FDA · Medical device recall

CareLink SmartSync Programmer… and 2 more products

Recall started Sept. 24, 2026 · FDA enforcement report Nov. 4, 2026 · On this site since Nov. 2, 2026 Class II

Reason: Software problem has the potential for an inaccurate displayed longevity estimate.
Status: Ongoing
Distribution: Worldwide distribution.

Enforcement report date: Nov. 4, 2026
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
Filed by: Medtronic, Inc.
Reason: Software problem has the potential for an inaccurate displayed longevity estimate.
Distribution pattern: Worldwide distribution.

What the record says about this device

A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.

“Software problem has the potential for an inaccurate displayed longevity estimate.”CareLink SmartSync Programmer, Model 24970A, Pulse generator, permanent, implantable, FDA enforcement report, 2026-11-04. The caption is the record's own words.

A generic device, not the product. The mark follows the record's own words.

If the drawing and the record's words differ, the words govern. A drawing is chosen by rules and an AI reading of the record and can miss what it means; report one with the form below.

FDA device name: Pulse Generator, Permanent, Implantable

3 products in this recall

CareLink SmartSync Programmer…

Product: CareLink SmartSync Programmer, Model 24970A, Pulse generator, permanent, implantable
Quantity: 11238 units
Codes and lots: GTIN 00763000044688, Serial Number SPM001252A; GTIN 00763000044688, Serial Number SPM001274A; GTIN 00763000044688, Serial Number SPM001303A; GTIN 00763000044688, Serial Number SPM001309A; GTIN 00763000044688, Serial Number SPM001317A; GTIN 00763000044688, Serial Number SPM001321A; GTIN 00763000044688, Serial Number SPM001323A; GTIN 00763000044688, Serial Number SPM001332A; GTIN 00763000044688, Serial Number SPM001375A; GTIN 00763000044688, Serial Number SPM001505A; GTIN 00763000044688, Serial Number SPM001554A; GTIN 00763000044688, Serial Number SPM001565A; GTIN 00763000044688, Serial Number SPM001576A; GTIN 00763000044688, Serial Number SPM001582A; GTIN 00763000044688, Serial Number SPM001585A; GTIN 00763000044688, Serial Number SPM001588A; GTIN 00763000044688, Serial Number SPM001589A; GTIN 00763000044688, Serial Number SPM001611A; GTIN 00763000044688, Serial Number SPM001619A; GTIN 00763000044688, Serial Number SPM001624A; GTIN 00763000044688, Serial Number SPM001634A; GTIN 00763000044688, Serial Number SPM001645A; GTIN 00763000044688, Serial Number SPM001657A; GTIN 00763000044688, Serial Number SPM001660A; GTIN 00763000044688, Serial Number SPM001673A; GTIN 00763000044688, Serial Number SPM001686A; GTIN 00763000044688, Serial Number SPM001687A; GTIN 00763000044688, Serial Number SPM001690A; GTIN 00763000044688, Serial Number SPM001698A; GTIN 00763000044688, Serial Number SPM001712A; GTIN 00763000044688, Serial Number SPM001713A; GTIN 00763000044688, Serial Number SPM001753A; GTIN 00763000044688, Serial Number SPM001769A; GTIN 00763000044688, Serial Number SPM001793A; GTIN 00763000044688, Serial Number SPM001812A; GTIN 00763000044688, Serial Number SPM001820A; GTIN 00763000044688, Serial Number SPM001972A; GTIN 00763000044688, Serial Number SPM001978A; GTIN 00763000044688, Serial Number SPM001989A; GTIN 00763000044688, Serial Number SPM001995A; GTIN 00763000044688, Serial Number SPM002001A; GTIN 00763000044688, Serial Number SPM002002A; GTIN 00763000044688, Serial Number SPM002003A; GTIN 00763000044688, Serial Number SPM002004A; GTIN 00763000044688, Serial Number SPM002006A; GTIN 00763000044688, Serial Number SPM002009A; GTIN 00763000044688, Serial Number SPM002011A; GTIN 00763000044688, Serial Number SPM002012A; GTIN 00763000044688, Serial Number SPM002013A; GTIN 00763000044688, Serial Number SPM002014A; GTIN 00763000044688, Serial Number SPM002015A; GTIN 00763000044688, Serial Number SPM002067A; GTIN 00763000044688, Serial Number SPM002088A; GTIN 00763000044688, Serial Number SPM002092A; GTIN 00763000044688, Serial Number SPM002097A; GTIN 00763000044688, Serial Number SPM002106A; GTIN 00763000044688, Serial Number SPM002107A; GTIN 00763000044688, Serial Number SPM002111A; GTIN 00763000044688, Serial Number SPM002112A; GTIN 00763000044688, Serial Number SPM002115A; GTIN 00763000044688, Serial Number SPM002118A; GTIN 00763000044688, Serial Number SPM002121A; GTIN 00763000044688, Serial Number SPM002122A; GTIN 00763000044688, Serial Number SPM002124A; GTIN 00763000044688, Serial Number SPM002128A; GTIN 00763000044688, Serial Number SPM002153A; GTIN 00763000044688, Serial Number SPM002248A; GTIN 00763000044688, Serial Number SPM002293A; GTIN 00763000044688, Serial Number SPM002356A; GTIN 00763000044688, Serial Number SPM002367A; GTIN 00763000044688, Serial Number SPM002441A; GTIN 00763000044688, Serial Number SPM002464A; GTIN 00763000044688, Serial Number SPM002467A; GTIN 00763000044688, Serial Number SPM002469A; GTIN 00763000044688, Serial Number SPM002472A; GTIN 00763000044688, Serial Number SPM002538A; GTIN 00763000044688, Serial Number SPM002539A; GTIN 00763000044688, Serial Number SPM002542A; GTIN 00763000044688, Serial Number SPM002576A; GTIN 00763000044688, Serial Number SPM002578A; GTIN 00763000044688, Serial Number SPM002585A; GTIN 00763000044688, Serial Number SPM002587A; GTIN 00763000044688, Serial Number SPM002618A; GTIN 00763000044688, Serial Number SPM002622A; GTIN 00763000044688, Serial Number SPM002646A; GTIN 00763000044688, Serial Number SPM002651A; GTIN 00763000044688, Serial Number SPM002672A; GTIN 00763000044688, Serial Number SPM002684A; GTIN 00763000044688, Serial Number SPM002697A; GTIN 00763000044688, Serial Number SPM002702A; GTIN 00763000044688, Serial Number SPM002703A; GTIN 00763000044688, Serial Number SPM002716A; GTIN 00763000044688, Serial Number SPM002720A; GTIN 00763000044688, Serial Number SPM002741A; GTIN 00763000044688, Serial Number SPM002742A; GTIN 00763000044688, Serial Number SPM002744A; GTIN 00763000044688, Serial Number SPM002921A; GTIN 00763000044688, Serial Number SPM002929A; GTIN 00763000044688, Serial Number SPM002931A; GTIN 00763000044688, Serial Number SPM002937A; GTIN 00763000044688, Serial Number SPM002941A; GTIN 00763000044688, Serial Number SPM002942A; GTIN 00763000044688, Serial Number SPM002954A; GTIN 00763000044688, Serial Number SPM002956A; GTIN 00763000044688, Serial Number SPM002964A; GTIN 00763000044688, Serial Number SPM002991A; GTIN 00763000044688, Serial Number SPM003001A; GTIN 00763000044688, Serial Number SPM003005A; GTIN 00763000044688, Serial Number SPM003009A; GTIN 00763000044688, Serial Number SPM003015A; GTIN 00763000044688, Serial Number SPM003020A; GTIN 00763000044688, Serial Number SPM003023A; GTIN 00763000044688, Serial Number SPM003033A; GTIN 00763000044688, Serial Number SPM003064A; GTIN 00763000044688, Serial Number SPM003071A; GTIN 00763000044688, Serial Number SPM003076A; GTIN 00763000044688, Serial Number SPM003077A; GTIN 00763000044688, Serial Number SPM003080A; GTIN 00763000044688, Serial Number SPM003081A; GTIN 00763000044688, Serial Number SPM003090A; GTIN 00763000044688, Serial Number SPM003097A; GTIN 00763000044688, Serial Number SPM003104A; GTIN 00763000044688, Serial Number SPM003107A; GTIN 00763000044688, Serial Number SPM003114A; GTIN 00763000044688, Serial Number SPM003115A; GTIN 00763000044688, Serial Number SPM003116A; GTIN 00763000044688, Serial Number SPM003120A; GTIN 00763000044688, Serial Number SPM003138A; GTIN 00763000044688, Serial Number SPM003140A; GTIN 00763000044688, Serial Number SPM003430A; GTIN 00763000044688, Serial Number SPM003465A; GTIN 00763000044688, Serial Number SPM003472A; GTIN 00763000044688, Serial Number SPM003475A; GTIN 00763000044688, Serial Number SPM003515A; GTIN 00763000044688, Serial Number SPM003517A; GTIN 00763000044688, Serial Number SPM003534A; GTIN 00763000044688, Serial Number SPM003546A; GTIN 00763000044688, Serial Number SPM003547A; GTIN 00763000044688, Serial Number SPM003556A; GTIN 00763000044688, Serial Number SPM003566A; GTIN 00763000044688, Serial Number SPM003568A; GTIN 00763000044688, Serial Number SPM003569A; GTIN 00763000044688, Serial Number SPM003570A; GTIN 00763000044688, Serial Number SPM003578A; GTIN 00763000044688, Serial Number SPM003585A; GTIN 00763000044688, Serial Number SPM003596A; GTIN 00763000044688, Serial Number SPM003607A; GTIN 00763000044688, Serial Number SPM003608A; GTIN 00763000044688, Serial Number SPM003609A; GTIN 00763000044688, Serial Number SPM003697A; GTIN 00763000044688, Serial Number SPM003701A; GTIN 00763000044688, Serial Number SPM003737A; GTIN 00763000044688, Serial Number SPM003971A; GTIN 00763000044688, Serial Number SPM004250A; GTIN 00763000044688, Serial Number SPM004403A; GTIN 00763000044688, Serial Number SPM004509A; GTIN 00763000044688, Serial Number SPM004537A; GTIN 00763000044688, Serial Number SPM004541A; GTIN 00763000044688, Serial Number SPM004542A; GTIN 00763000044688, Serial Number SPM004546A; GTIN 00763000044688, Serial Number SPM004550A; GTIN 00763000044688, Serial Number SPM004555A; GTIN 00763000044688, Serial Number SPM004578A; GTIN 00763000044688, Serial Number SPM004580A; GTIN 00763000044688, Serial Number SPM004585A; GTIN 00763000044688, Serial Number SPM004591A; GTIN 00763000044688, Serial Number SPM004594A; GTIN 00763000044688, Serial Number SPM004595A; GTIN 00763000044688, Serial Number SPM004621A; GTIN 00763000044688, Serial Number SPM004670A; GTIN 00763000044688, Serial Number SPM004682A; GTIN 00763000044688, Serial Number SPM004684A; GTIN 00763000044688, Serial Number SPM004692A; GTIN 00763000044688, Serial Number SPM004694A; GTIN 00763000044688, Serial Number SPM004700A; GTIN 00763000044688, Serial Number SPM004712A; GTIN 00763000044688, Serial Number SPM004717A; GTIN 00763000044688, Serial Number SPM004752A; GTIN 00763000044688, Serial Number SPM004753A; GTIN 00763000044688, Serial Number SPM004754A; GTIN 00763000044688, Serial Number SPM004773A; GTIN 00763000044688, Serial Number SPM004784A; GTIN 00763000044688, Serial Number SPM004795A; GTIN 00763000044688, Serial Number SPM004800A; GTIN 00763000044688, Serial Number SPM004802A; GTIN 00643169957657, Serial Number SPM001459A; GTIN 00643169957657, Serial Number SPM001461A; GTIN 00643169957657, Serial Number SPM002410A; GTIN 00643169957657, Serial Number SPM002415A; GTIN 00643169957657, Serial Number SPM002424A; GTIN 00643169957657, Serial Number SPM002736A; GTIN 00643169957657, Serial Number SPM002756A; GTIN 00643169957657, Serial Number SPM002796A; GTIN 00643169957657, Serial Number SPM002883A; GTIN 00643169957657, Serial Number SPM002885A; GTIN 00643169957657, Serial Number SPM003141A; GTIN 00643169957657, Serial Number SPM003213A; GTIN 00643169957657, Serial Number SPM003220A; GTIN 00643169957657, Serial Number SPM003318A; GTIN 00643169957657, Serial Number SPM003339A; GTIN 00643169957657, Serial Number SPM003491A; GTIN 00643169957657, Serial Number SPM003818A; GTIN 00643169957657, Serial Number SPM003843A; GTIN 00643169957657, Serial Number SPM003844A; GTIN 00643169957657, Serial Number SPM003993A; GTIN 00643169957657, Serial Number SPM004052A; GTIN 00643169957657, Serial Number SPM004055A; GTIN 00643169957657, Serial Number SPM004178A; GTIN 00643169957657, Serial Number SPM004501A; GTIN 00643169957657, Serial Number SPM004507A; GTIN 00643169957657, Serial Number SPM004508A; GTIN 00643169957657, Serial Number SPM004512A; GTIN 00643169957657, Serial Number SPM004520A; GTIN 00643169957657, Serial Number SPM004522A; GTIN 00643169957657, Serial Number SPM004524A; GTIN 00643169957657, Serial Number SPM004527A; GTIN 00643169957657, Serial Number SPM004528A; GTIN 00643169957657, Serial Number SPM004529A; GTIN 00643169957657, Serial Number SPM004536A; GTIN 00643169957657, Serial Number SPM004548A; GTIN 00643169957657, Serial Number SPM004654A; GTIN 00643169957657, Serial Number SPM004735A; GTIN 00643169957657, Serial Number SPM004840A; GTIN 00643169957657, Serial Number SPM004842A; GTIN 00643169957657, Serial Number SPM004843A; GTIN 00643169957657, Serial Number SPM004846A; GTIN 00643169957657, Serial Number SPM004847A; GTIN 00643169957657, Serial Number SPM004849A; GTIN 00643169957657, Serial Number SPM004851A; GTIN 00643169957657, Serial Number SPM004852A; GTIN 00643169957657, Serial Number SPM004854A; GTIN 00643169957657, Serial Number SPM004855A; GTIN 00643169957657, Serial Number SPM004856A; GTIN 00643169957657, Serial Number SPM004858A; GTIN 00643169957657, Serial Number SPM004860A; GTIN 00643169957657, Serial Number SPM004862A; GTIN 00643169957657, Serial Number SPM004863A; GTIN 00643169957657, Serial Number SPM004864A; GTIN 00643169957657, Serial Number SPM004867A; GTIN 00643169957657, Serial Number SPM004868A; GTIN 00643169957657, Serial Number SPM004871A; GTIN 00643169957657, Serial Number SPM004873A; GTIN 00643169957657, Serial Number SPM004875A; GTIN 00643169957657, Serial Number SPM004876A; GTIN 00643169957657, Serial Number SPM004877A; GTIN 00643169957657, Serial Number SPM004878A; GTIN 00643169957657, Serial Number SPM004879A; GTIN 00643169957657, Serial Number SPM004884A; GTIN 00643169957657, Serial Number SPM004886A; GTIN 00643169957657, Serial Number SPM004889A; GTIN 00643169957657, Serial Number SPM004890A; GTIN 00643169957657, Serial Number SPM004894A; GTIN 00643169957657, Serial Number SPM004895A; GTIN 00643169957657, Serial Number SPM004896A; GTIN 00643169957657, Serial Number SPM004897A; GTIN…; The first 12,000 characters of this field; the agency record has the rest.
Recall started: Sept. 24, 2026
Voluntary or mandated: Voluntary: Firm initiated
Device type: Pulse Generator, Permanent, Implantable
Root cause (FDA): Software design
What the company told customers: Medtronic issued a Communication regarding a software update to its consignees on 9/24/2026 via UPS 2-day delivery. The notice explained the issues and requested the consignees to update the SmartSync and return a confirmation certificate (or equivalent record) confirming they have received the notification and completed the action. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been distributed. For questions, contact Medtronic Technical Services at 800-638-1991 or the local Medtronic Sales Representative.
Recall number: Z-0302-2027

CareLink SmartSync…

Product: CareLink SmartSync, RF Head Patient Connector, Model 24967, Pulse generator, permanent, implantable
Quantity: 11741 units
Codes and lots: GTIN 00763000060435, Serial Number RFA001598A; GTIN 00763000060435, Serial Number RFA001602A; GTIN 00763000060435, Serial Number RFA001786A; GTIN 00763000060435, Serial Number RFA001826A; GTIN 00763000060435, Serial Number RFA002016A; GTIN 00763000060435, Serial Number RFA002095A; GTIN 00763000060435, Serial Number RFA002591A; GTIN 00763000060435, Serial Number RFA003113A; GTIN 00763000060435, Serial Number RFA003146A; GTIN 00763000060435, Serial Number RFA003306A; GTIN 00763000060435, Serial Number RFA005031A; GTIN 00763000060435, Serial Number RFA005097A; GTIN 00763000060435, Serial Number RFA005103A; GTIN 00763000060435, Serial Number RFA008830A; GTIN 00763000060435, Serial Number RFA014171A; GTIN 00763000060435, Serial Number RFA014218A; GTIN 00763000060435, Serial Number RFA014252A; GTIN 00763000060435, Serial Number RFA014258A; GTIN 00763000060435, Serial Number RFA014278A; GTIN 00763000060435, Serial Number RFA014286A; GTIN 00763000060435, Serial Number RFA014342A; GTIN 00763000060435, Serial Number RFA014609A; GTIN 00763000060435, Serial Number RFA014653A; GTIN 00763000060435, Serial Number RFA014885A; GTIN 00763000060435, Serial Number RFA014952A; GTIN 00763000060435, Serial Number RFA014996A; GTIN 00763000060435, Serial Number RFA015015A; GTIN 00763000060435, Serial Number RFA016648A; GTIN 00763000060435, Serial Number RFA016815A; GTIN 00763000060435, Serial Number RFA016817A; GTIN 00763000060435, Serial Number RFA017064A; GTIN 00763000060435, Serial Number RFA017468A; GTIN 00763000060435, Serial Number RFA017880A; GTIN 00763000060435, Serial Number RFA017906A; GTIN 00763000060435, Serial Number RFA017907A; GTIN 00763000060435, Serial Number RFA017929A; GTIN 00763000060435, Serial Number RFA017947A; GTIN 00763000060435, Serial Number RFA018801A; GTIN 00763000060435, Serial Number RFA019059A; GTIN 00763000060435, Serial Number RFA021437A; GTIN 00763000060435, Serial Number RFA021450A; GTIN 00763000060435, Serial Number RFA021477A; GTIN 00763000060435, Serial Number RFA021618A; GTIN 00763000060435, Serial Number RFA021626A; GTIN 00763000060435, Serial Number RFA021652A; GTIN 00763000060435, Serial Number RFA021661A; GTIN 00763000060435, Serial Number RFA036107A; GTIN 00763000060435, Serial Number RFA036123A; GTIN 00763000060435, Serial Number RFA036190A; GTIN 00763000060435, Serial Number RFA036411A; GTIN 00763000060435, Serial Number RFA036460A; GTIN 00763000060435, Serial Number RFA037606A; GTIN 00763000060435, Serial Number RFA037647A; GTIN 00763000060435, Serial Number RFA037648A; GTIN 00763000060435, Serial Number RFA037650A; GTIN 00763000060435, Serial Number RFA037794A; GTIN 00763000060435, Serial Number RFA038977A; GTIN 00763000060435, Serial Number RFA039112A; GTIN 00763000060435, Serial Number RFA039113A; GTIN 00763000060435, Serial Number RFA040362A; GTIN 00763000060435, Serial Number RFA040386A; GTIN 00763000060435, Serial Number RFA040584A; GTIN 00763000060435, Serial Number RFA040632A; GTIN 00763000060435, Serial Number RFA040655A; GTIN 00763000060435, Serial Number RFA040688A; GTIN 00763000060435, Serial Number RFA040689A; GTIN 00763000060435, Serial Number RFA040765A; GTIN 00763000060435, Serial Number RFA040802A; GTIN 00763000060435, Serial Number RFA040823A; GTIN 00763000060435, Serial Number RFA040848A; GTIN 00763000060435, Serial Number RFA040850A; GTIN 00763000060435, Serial Number RFA040853A; GTIN 00763000060435, Serial Number RFA040905A; GTIN 00763000060435, Serial Number RFA040911A; GTIN 00763000060435, Serial Number RFA040918A; GTIN 00763000060435, Serial Number RFA041045A; GTIN 00763000060435, Serial Number RFA041053A; GTIN 00763000060435, Serial Number RFA041211A; GTIN 00763000060435, Serial Number RFA041213A; GTIN 00763000060435, Serial Number RFA041375A; GTIN 00763000060435, Serial Number RFA041376A; GTIN 00763000060435, Serial Number RFA041383A; GTIN 00763000060435, Serial Number RFA041384A; GTIN 00763000060435, Serial Number RFA041450A; GTIN 00763000060435, Serial Number RFA041455A; GTIN 00763000060435, Serial Number RFA041457A; GTIN 00763000060435, Serial Number RFA041483A; GTIN 00763000060435, Serial Number RFA041511A; GTIN 00763000060435, Serial Number RFA041514A; GTIN 00763000060435, Serial Number RFA041515A; GTIN 00763000060435, Serial Number RFA041518A; GTIN 00763000060435, Serial Number RFA041537A; GTIN 00763000060435, Serial Number RFA041559A; GTIN 00763000060435, Serial Number RFA041568A; GTIN 00763000060435, Serial Number RFA041572A; GTIN 00763000060435, Serial Number RFA041573A; GTIN 00763000060435, Serial Number RFA041600A; GTIN 00763000060435, Serial Number RFA042036A; GTIN 00763000060435, Serial Number RFA042051A; GTIN 00763000060435, Serial Number RFA042055A; GTIN 00763000060435, Serial Number RFA042056A; GTIN 00763000060435, Serial Number RFA042124A; GTIN 00763000060435, Serial Number RFA042131A; GTIN 00763000060435, Serial Number RFA042132A; GTIN 00763000060435, Serial Number RFA042141A; GTIN 00763000060435, Serial Number RFA042147A; GTIN 00763000060435, Serial Number RFA042269A; GTIN 00763000060435, Serial Number RFA042413A; GTIN 00763000060435, Serial Number RFA042417A; GTIN 00763000060435, Serial Number RFA042425A; GTIN 00763000060435, Serial Number RFA042431A; GTIN 00763000060435, Serial Number RFA042477A; GTIN 00763000060435, Serial Number RFA042513A; GTIN 00763000060435, Serial Number RFA042630A; GTIN 00763000060435, Serial Number RFA042684A; GTIN 00763000060435, Serial Number RFA042929A; GTIN 00763000060435, Serial Number RFA042966A; GTIN 00763000060435, Serial Number RFA043004A; GTIN 00763000060435, Serial Number RFA043005A; GTIN 00763000060435, Serial Number RFA043006A; GTIN 00763000060435, Serial Number RFA043013A; GTIN 00763000060435, Serial Number RFA043046A; GTIN 00763000060435, Serial Number RFA043113A; GTIN 00763000060435, Serial Number RFA043442A; GTIN 00763000060435, Serial Number RFA043519A; GTIN 00763000060435, Serial Number RFA043612A; GTIN 00763000060435, Serial Number RFA043770A; GTIN 00763000060435, Serial Number RFA043777A; GTIN 00763000060435, Serial Number RFA043838A; GTIN 00763000060435, Serial Number RFA044072A; GTIN 00763000060435, Serial Number RFA044122A; GTIN 00763000060435, Serial Number RFA044312A; GTIN 00763000060435, Serial Number RFA044417A; GTIN 00763000060435, Serial Number RFA044485A; GTIN 00763000060435, Serial Number RFA044486A; GTIN 00763000060435, Serial Number RFA044505A; GTIN 00763000060435, Serial Number RFA044506A; GTIN 00763000060435, Serial Number RFA044628A; GTIN 00763000060435, Serial Number RFA044684A; GTIN 00763000060435, Serial Number RFA044685A; GTIN 00763000060435, Serial Number RFA044687A; GTIN 00763000060435, Serial Number RFA044700A; GTIN 00763000060435, Serial Number RFA044805A; GTIN 00763000060435, Serial Number RFA045057A; GTIN 00763000060435, Serial Number RFA045058A; GTIN 00763000060435, Serial Number RFA045059A; GTIN 00763000060435, Serial Number RFA045060A; GTIN 00763000060435, Serial Number RFA045181A; GTIN 00763000060435, Serial Number RFA045281A; GTIN 00763000060435, Serial Number RFA045291A; GTIN 00763000060435, Serial Number RFA045295A; GTIN 00763000060435, Serial Number RFA045328A; GTIN 00763000060435, Serial Number RFA045386A; GTIN 00763000060428, Serial Number RFA001761A; GTIN 00763000060428, Serial Number RFA001793A; GTIN 00763000060428, Serial Number RFA001814A; GTIN 00763000060428, Serial Number RFA001845A; GTIN 00763000060428, Serial Number RFA001854A; GTIN 00763000060428, Serial Number RFA001855A; GTIN 00763000060428, Serial Number RFA001857A; GTIN 00763000060428, Serial Number RFA001859A; GTIN 00763000060428, Serial Number RFA001867A; GTIN 00763000060428, Serial Number RFA001885A; GTIN 00763000060428, Serial Number RFA001888A; GTIN 00763000060428, Serial Number RFA001891A; GTIN 00763000060428, Serial Number RFA001952A; GTIN 00763000060428, Serial Number RFA001994A; GTIN 00763000060428, Serial Number RFA001996A; GTIN 00763000060428, Serial Number RFA002014A; GTIN 00763000060428, Serial Number RFA002067A; GTIN 00763000060428, Serial Number RFA002129A; GTIN 00763000060428, Serial Number RFA002131A; GTIN 00763000060428, Serial Number RFA002141A; GTIN 00763000060428, Serial Number RFA002145A; GTIN 00763000060428, Serial Number RFA002162A; GTIN 00763000060428, Serial Number RFA002166A; GTIN 00763000060428, Serial Number RFA002217A; GTIN 00763000060428, Serial Number RFA002220A; GTIN 00763000060428, Serial Number RFA002250A; GTIN 00763000060428, Serial Number RFA002289A; GTIN 00763000060428, Serial Number RFA002291A; GTIN 00763000060428, Serial Number RFA002312A; GTIN 00763000060428, Serial Number RFA002319A; GTIN 00763000060428, Serial Number RFA002322A; GTIN 00763000060428, Serial Number RFA002325A; GTIN 00763000060428, Serial Number RFA002334A; GTIN 00763000060428, Serial Number RFA002337A; GTIN 00763000060428, Serial Number RFA002340A; GTIN 00763000060428, Serial Number RFA002343A; GTIN 00763000060428, Serial Number RFA002347A; GTIN 00763000060428, Serial Number RFA002368A; GTIN 00763000060428, Serial Number RFA002388A; GTIN 00763000060428, Serial Number RFA002390A; GTIN 00763000060428, Serial Number RFA002405A; GTIN 00763000060428, Serial Number RFA002406A; GTIN 00763000060428, Serial Number RFA002412A; GTIN 00763000060428, Serial Number RFA002428A; GTIN 00763000060428, Serial Number RFA002433A; GTIN 00763000060428, Serial Number RFA002440A; GTIN 00763000060428, Serial Number RFA002448A; GTIN 00763000060428, Serial Number RFA002449A; GTIN 00763000060428, Serial Number RFA002452A; GTIN 00763000060428, Serial Number RFA002460A; GTIN 00763000060428, Serial Number RFA002486A; GTIN 00763000060428, Serial Number RFA002491A; GTIN 00763000060428, Serial Number RFA002496A; GTIN 00763000060428, Serial Number RFA002506A; GTIN 00763000060428, Serial Number RFA002513A; GTIN 00763000060428, Serial Number RFA002525A; GTIN 00763000060428, Serial Number RFA002546A; GTIN 00763000060428, Serial Number RFA002548A; GTIN 00763000060428, Serial Number RFA002561A; GTIN 00763000060428, Serial Number RFA002565A; GTIN 00763000060428, Serial Number RFA002576A; GTIN 00763000060428, Serial Number RFA002587A; GTIN 00763000060428, Serial Number RFA002589A; GTIN 00763000060428, Serial Number RFA002594A; GTIN 00763000060428, Serial Number RFA002608A; GTIN 00763000060428, Serial Number RFA002610A; GTIN 00763000060428, Serial Number RFA002613A; GTIN 00763000060428, Serial Number RFA002618A; GTIN 00763000060428, Serial Number RFA002619A; GTIN 00763000060428, Serial Number RFA002629A; GTIN 00763000060428, Serial Number RFA002643A; GTIN 00763000060428, Serial Number RFA002645A; GTIN 00763000060428, Serial Number RFA002652A; GTIN 00763000060428, Serial Number RFA002674A; GTIN 00763000060428, Serial Number RFA002690A; GTIN 00763000060428, Serial Number RFA002691A; GTIN 00763000060428, Serial Number RFA002700A; GTIN 00763000060428, Serial Number RFA002990A; GTIN 00763000060428, Serial Number RFA002994A; GTIN 00763000060428, Serial Number RFA002996A; GTIN 00763000060428, Serial Number RFA003007A; GTIN 00763000060428, Serial Number RFA003244A; GTIN 00763000060428, Serial Number RFA003247A; GTIN 00763000060428, Serial Number RFA003250A; GTIN 00763000060428, Serial Number RFA003259A; GTIN 00763000060428, Serial Number RFA003260A; GTIN 00763000060428, Serial Number RFA003938A; GTIN 00763000060428, Serial Number RFA004003A; GTIN 00763000060428, Serial Number RFA004057A; GTIN 00763000060428, Serial Number RFA004058A; GTIN 00763000060428, Serial Number RFA004076A; GTIN 00763000060428, Serial Number RFA004157A; GTIN 00763000060428, Serial Number RFA004158A; GTIN 00763000060428, Serial Number RFA004162A; GTIN 00763000060428, Serial Number RFA004173A; GTIN 00763000060428, Serial Number RFA004181A; GTIN 00763000060428, Serial Number RFA004204A; GTIN 00763000060428, Serial Number RFA004207A; GTIN 00763000060428, Serial Number RFA004214A; GTIN 00763000060428, Serial Number RFA004215A; GTIN 00763000060428, Serial Number RFA004263A; GTIN 00763000060428, Serial Number RFA004275A; GTIN…; The first 12,000 characters of this field; the agency record has the rest.
Recall started: Sept. 24, 2026
Voluntary or mandated: Voluntary: Firm initiated
Device type: Pulse Generator, Permanent, Implantable
Root cause (FDA): Software design
What the company told customers: Medtronic issued a Communication regarding a software update to its consignees on 9/24/2026 via UPS 2-day delivery. The notice explained the issues and requested the consignees to update the SmartSync and return a confirmation certificate (or equivalent record) confirming they have received the notification and completed the action. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been distributed. For questions, contact Medtronic Technical Services at 800-638-1991 or the local Medtronic Sales Representative.
Recall number: Z-0303-2027

CareLink SmartSync Device Manager App…

Product: CareLink SmartSync Device Manager App, Model M01A02, Pulse generator, permanent, implantable
Quantity: 38115 units
Codes and lots: GTIN none, Serial Numbers: C2TM4QV0XC, DL269KH953, DVP79R6KV6, FDG69FQX19, FHHG9CHX3H, FVFVMVPK7N, FVQYCR34T1, FYJPFH6099, G19LC9X7J7, G2VQP97D2J, GR4R69G4VN, GW7TFH7HQ0, GX44D2GDP4, H3G0Q6W9T7, H3QGWTYW42, H9GX6NHL45, HD2104VHK2, HD972G7JFV, HK212M19PD, HPH6FQFHF9, J4G16FXW05, JGYXLTCXLW, K6HTFXLW2T, KD0MV7CVQG, KQL96W3WGF, MGF4DJCVFL, Q76YQPKJQK, QXGQV69765, RH1XG26WGV, V669K664R6, X2XDNVV5CF, C2TR7WKTWW, C44L16FCW7, C52X07MXR7, C5Y6H49KH6, C69TG9WDJV, C69W9N6PWF, C6VT6QX05N, C9W7NX7X11, CFQT0F4N2T, CH02T6FTFJ, CJ2VX4PCQT, CJF6VNT3HT, CJR4Y6920X, CM44FWL9G7, CP63R629G3, CQ94K67LJF, CW3KFX02JG, CW7XHL6MPY, CW9LQ9593X, CWJX3439G5, CWNW7QK7YW, CWR0W7J4VL, CWRR649J63, CWVJ60WDCC, CWVXWHWG17, CWYMJQKVDN, CX99YN7PL2, CXGCY70L60, CXWJLXQYX6, D04T9VT46M, D0JFR44TD2, D4070M21J1, D494VRK60H, D617Y162PJ, D6VF5YXXH1, D70KX7QJ22, D723GV1WQW, D7K79L70F6, D7LG73X9JW, D7RJ2T9KC9, D96NK032FY, DH94DT62V4, DTD172G4YP, DY63799N29, F062YWR7V3, F2NL42C2MM, F3WV20DVTJ, F3Y0R2YGQT, F4KNXN3609, F4XWWJ5TXM, F5VX9GHG0W, F67W79C3FH, F67XVY2M27, F6C6667WJ6, F6P9MNVDYR, F7NP73CN7H, F7NYPL2MKC, FD90MH6YVY, FH497W575J, FHN2F9F614, FHYYG7FDJP, FK6JX9D61J, FKPFXKGWC4, FLYF7YXF69, FMHXCDJJMG, FNXQ10D4RW, FPQT4VT2JN, FT6HQK60D7, FVJG2N26J1, FWRJF0VMR9, FWVYMJH9TR, FX1Y74DLC4, FX2337J9GQ, FX76D726VH, FY4016742W, FY90KH799T, FYD90QM3W0, G07VQ2G2XK, G0HK4Q75WV, G170JGHLQL, G1C96DL6C9, G1CF04Q3H9, G2DT932HNY, G2PX4QHHG3, G46K22XXN9, G4TYJ0QM7X, G4WCV2RYR7, G5X4CXQYR3, G6J29221WX, G9C979CX95, GH4V46FGPG, GJ2KD063F7, GJ9YWDKQCV, GJQMT4K3DT, GL91WL5X7M, GMK3JWNR94, GMKPJ67Y4P, GN7N7K7XYM, GN9216D3R4, GNPRYX0XWP, GP24M66J3Y, GPR6RPFCJ7, GQ0CV4CF0H, GQ9VK1Q5L9, GXPG3JFMJX, GY20FGY4CR, GY46FPG6V0, H16VP6XV2T, H39739V6QN, H3QRQ33QY4, H40JWD94DP, H41R97CY32, H5717KF97X, H60XQTVYHF, H79KM7VW7H, H7JXKWTY72, H96J73HRX5, H9PK00DXPG, HD7JWFXX6G, HDHKC6MWXF, HNW5L25VHC, HPF0VMGJ9P, HPR2DF7W6L, HPWFDJMH4C, HR9G9KJ20D, HT9VP9QRH4, HV64G5W0H7, HW0WG7063M, HW4WWH4G4V, HW7TP7GCVH, HYW5RV7MHP, J191V6NC7L, J1Y5C3YQ9P, J22FPM725L, J29324MYP1, J2CR2WMHC3, J3606DRWQ5, J36KQ100X2, J4F9P2VFNM, J4FM6HYJVC, J5R2252J54, J6DCFQKPQ6, J6P44HPQHQ, J9PWC6JW6T, JC4XV2YFX1, JCYD6591C2, JFQ23154XW, JL6DVPYT65, JMY3YYX0JM, JQ9TYX4DQ4, JQWVP7D726, JV947XXNMJ, JVX5QJMGYN, JWCYD09Q65, JXCQQRYP4Q, K247DP7QHR, K26QPK4FLK, K2QQXCWXFD, K2R6Y0FJWF, K399W0XXLW, K3WRYVY2L9, K4PV71RYGR, K59MPM2626, K6QQT56X0X, K725YXDXCT, K7PHR6L9FM, K9H7RX1Y4K, KF7JVVMQDH, KGFG4J2YJJ, KH2VNJ07FR, KJKXQJ2N7T, KJTY47P09P, KK6L4F2QMT, KVCTV54ML2, KVG6P2C2CN, KVWH0C65N4, KY2C5752WP, L3R6FQVV6J, L6TGCLG0HQ, L70YH9FD60, L793LK2JGK, L7FFQLH21W, L7K7HQ5WG2, L7QDQ559KG, L92RX12WX6, L9LG97R4TM, LCDT65GWHG, LD4YW295V2, LDY9PYKX93, LF3V6DV6NT, LFT9V37W2J, LNFDF0QNJ9, LQCPGXG1QX, LTJ7FD24R9, M02446WFM3, M12M20W14V, M70QKX77YL, MD977JY0XM, MFL245N23T, MGQQWQ1CW5, MH9R3JT6YK, MJYDHQGK14, MM22G09X77, MMW1DWYK16, MPYVQX17M7, MWF627WW62, MWPP6JK9HT, MWQ0MJ9R91, MWYMVF6M5W, N4LNPH44GW, N5GQHFN63C, N9W73D2W3M, NC604QTD4K, NF22JHCDK6, NH947TXNPC, NJJXRQ914K, NVY9C260XG, NXDG9KM2Y6, NY6H9GNF97, P3W6DJP93J, P70VF9DYXF, P7P3V7X0RH, P94CRW75WY, P9755F74XY, PCWX4NRWXV, PG455CQTX3, PGL9KQYWM9, PH0JXRYX0J, PH663J9QRP, PN79L7V2WT, PQ2WXH6WP3, PQ4RW2J2J0, PQHR4XC9N7, PX2GQXDXVK, PXQQCP74Q4, Q6VWXPXJXK, QF9YQM9PC2, QGJQ1G6XNW, QLWRXK1GL2, QQK6CGWQ9F, QQL2R9RF9X, QRXM54QWTC, QRXRMY460X, QV33WCGFPM, QX5MHJH9X5, QXMK4XF9H2, R1VV1Q5XX3, R23J57GKX7, R3W6QTPQ9W, R4TJQN729X, RH0C2PYN6P, RHHK7KQV9W, RJPWNWVQJF, RQ4W4036KX, RVY1Q27RGP, RW16KH2WHQ, TC3Q2X7HCQ, TPXKFGYHWT, TW79MF2HFD, V3P57VVHD7, V56LQ6WNHR, V6272KDY4G, VJ99YYW3VK, VQNFYQXJQ4, VQXK1H4QYP, VTG7LR7Q0Y, W077G7RCY4, W25M9TNFW9, WF4TGCRXNQ, WKHG3H69GR, WQFK3MKVHW, WR4YQWDG34, WVVCY54HDH, X13RW1CDFR, X1XDT94R95, X2GXFKYCNW, X40N6TVMCQ, X63431WX7R, X64M9YFX4H, XHWR0Q2JRH, XL6KMGJH6D, XN64G710WD, XVRXD95279, XX42F5XXLW, Y946WJ1WNY, YFLY0HWMM9, YFR7M0VXPM, YH63JXDPFC, YHHQQJPC21, YM71D70CVF, YMCQDXRVF9, YN9V2Y6RN2, YNJL2X2VVJ, YQD4PC72GH, YQG53P9QLF, YQNQH66YMG, YVGQLGWF0W, YWG3R61772, CHXM497GFX, CYMVDW70H2, F3CGFXG9Q6, J65QNVWFY3, J6WC32G9FY, JRVV17HPMV, K69F62TVMW, LTF9WXYHX4, LVP2RH4KWP, M2W9RK4V5C, MYC0XR7WJD, P6K2CYNWJJ, C2H330FH6N, C2JYYPQXDK, C4072PL47Y, C4NJ4J1XD6, C7RYCHGLWD, C9L4W37PYM, C9R2Q490TL, CFF7FLQVMC, CJ7F14JC4P, CKQWW4CQYW, CQ30NRW6TT, CQT602245L, CTJJG3RD2Q, CX2LQJ49GG, CXQY6HW7TD, CYHXKJQ6WD, D226W907D1, D2CWWYTX91, D3H7V59P7Y, D3KFWWXGCX, DF231F7RN2, DWFHM400HT, F0GJH6CWYH, F4QKG33NHY, F9XHV4KWX5, FT9G6M64PF, FVJKFWQQPM, FWVHYRPQR0, G609KXW3QK, GD6V6Q3100, GFY43V32DJ, GGXQFTXT95, GVX297JT26, H9KXTQXQK9, HQX9FHWXWR, HX4D5P94WV, HYWGWXF732, J3W9TD7247, J52VMRPFWC, J66RJ4F7V1, J66V6W7GFP, J6QHXJ0W0C, JC4NPWQ59P, JF3Y2H4NTH, JG4F4652DQ, JKWLY9GYKH, JMT29JFPNY, JQY3Y14R36, JR2XVQR96X, JRVGWJVJ19, JVWWWMXGXQ, JY3KQQY7WT, JYD2Y0MD7D, K33QV9G03M, K49QGRWR2R, K4LVHMW5XV, KC7V4W5FX9, KCXM6RQLP6, KF6MWD2FGM, KFW0WMWW5V, KL61P6PTGG, KN4MY5LQWC, KT6HT0LGV4, L496XTT4DN, L4XD3N4VG9, LF3HM6L7J9, LJWY4G966F, LMW0Y7W26D, M4NJ4MFM9M, MFXJJC469Y, MQ6LYJ3QH5, N4VFQ9VH6N, P5F499GK07, P6FVQN4H3G, P749DDH5MW, PR94RYF4XM, Q414Q1F7J2, QR16KY4426, T0907PC2RR, TC2J125Q76, TK2WRWWWLC, VCXX1DQW0T, VNM79Y7WKG, W52T9QJ7H6, WF95GJ9K36, WXVQF9Y32D, X01C4T3203, XKYQL2VC3Y, XWY7JRQV4C, Y0GHC0FP24, C4C14CNXJK, C4JWK7P54Q, C71XHW077C, C9G7TN6NW0, CD6R35QK66, CF9MT6NCPY, CGFWX56Y9Y, CJFJ4PQ4RW, CL2K7T2R94, CMW6W909TR, CN6H6X2TR6, CQ662FVF2K, CRQHG72C17, CW26R509FM, CWCRX17QJG, CWD4R4JQGQ, CWPL9PT77C, CWR19DQJK2, CWV7J60V2G, CWVTHR2993, CY296HWVJ9, D0WVJVNJ33, D195Y2K4X6, D4HWM6X63Y, DJ6DCL9F33, DJKQ67R3MP, DK0VD4PC70, DMPN2FPY70, DMWQ02079M, DN9LWTW7WN, DQW91NQF9W, F27MW9KQRL, F2Y9FV603G, F47M44FFHK, F4K4M22WQJ, F7VH2FWJ0N, F96XG37KKG, FG6Y5926R2, FG74RGV93G, FJ1QX5DW6R, FJJTHKDM2X, FQ3QD4K2NY, FVHYQD449G, FW2R92C9PJ, FW4K5QJ6QL, FX7XDT93VN, FYHK9K0M9V, FYVRC4PHFJ, G2TD7L66KV, G2TYJD4XTG, G34JF926R9, G63GKPVGF2, G67QY6CJF2, G6R6HY6545, GC93G6GC2W, GDG2372KWV, GFQ4YXVDY7, GQ9J170YVM, GTWR3T6C21, GXC96Y0JQ2, H2MHV96MGM, H3H79L6QNV, HC0H7VTWGG, HC2J4CL4TC, HFYRR04C24, HRV0064L75, HVVCTW9VK2, HW403Y30T4, HX20VDHJPF, J0CF66VVFJ, J0QPWNL4LH, J296Q6TW7P, J3104DYYXR, J3X1DYXNPW, J44Q41C9LK, J4C4LJ6DQL, J4CN400PXP, J5JVC3W42P, J6XPWFHWXK, J90577576G, JC6QLCM76R, JFMVPHMH23, JGHV7KT6NP, JKJVF1Q12Q, JL93J57MH7, JL9HHGQT43, JLCJ2DFCY9, JQVFDK09X0, JR0X5GJK0M, JT4LXX112J, JT9VYKTV2X, JVWFX6WGVV, JW17DQ0CHK, JWVXJWTGDM, JXCYTWL7QY, JYHNGC76K1, K07XMXCGP7, K16L7LQ620, K19LR423DW, K224FN4YYP, K24MD6K9CW, K24PW0Y74V, K2RCJX22TD, K42G736G5Y, K62VLQCW39, K94166HF2L, KCXJQK4N71, KFKHGYF0Q1, KJ4HM96XHN, KK2G433MWX, KK7023JDYV, KK9KG34K2N, KKH6T436JF, KL465D736L, KM4454T471, KMG0GJK7KX, KQ59NM422D, KQRY1VYQNP, KT7F9R3HDQ, KVHT9R7XW5, KW9QF9LTV4, KXD7X6YMPF, KYLF1WW9D3, L3DCL63LXY, L4LF6XPQG3, L4RQDKK633, L6MGGV9PCW, L6R6FPJQ06, L93137YXQX, L9X1JQP60H, LCM0JHK0F2, LMJ7JFVWJT, LQ259NJ662, LTXK4MQDJV, LX4YCNX0KR, M029XL2WQW, M16J6X6KFV, M20NKHW5P7, M3YF7349L9, M6CT7CWN9Q, M6RDP9XFDH, M7TMCFM4TW, M7WPNWLYK5, MC6MF4WG3N, MD9PGX617F, MGH97QF7X4, 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R3W9W3K4FR, R7GC7KQYN6, RXKWC6XTD7, T1PM9KDQ7P, TD12NKQT32…; The first 12,000 characters of this field; the agency record has the rest.
Recall started: Sept. 24, 2026
Voluntary or mandated: Voluntary: Firm initiated
Device type: Pulse Generator, Permanent, Implantable
Root cause (FDA): Software design
What the company told customers: Medtronic issued a Communication regarding a software update to its consignees on 9/24/2026 via UPS 2-day delivery. The notice explained the issues and requested the consignees to update the SmartSync and return a confirmation certificate (or equivalent record) confirming they have received the notification and completed the action. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been distributed. For questions, contact Medtronic Technical Services at 800-638-1991 or the local Medtronic Sales Representative.
Recall number: Z-0304-2027

This recall among the others

FDA's enforcement report came 41 days after the firm started the recall. For half of the 860 FDA medical device recall events reported in 2026 so far with a start date, it took 49 days or fewer (by year).
Medtronic: 14 other recalls or notices on this site in the three years before this one (from Nov. 5, 2023).

Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.

What should I do? How serious is a recall? Classes and warnings explained · How to read this record

Source: FDA · Medical device enforcement reports, recall numbers Z-0302-2027, Z-0303-2027, Z-0304-2027. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.

Cite this record

FDA recall record Z-0302-2027, Nov. 4, 2026. "CareLink SmartSync Programmer… and 2 more products." PlainRecords, https://plainrecords.com/recall/device/z-0302-2027/ (on this site since Nov. 2, 2026; as of the day it was built).

At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections

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