PlainRecordsIon Flexison Biopsy Needle…
- Reason
- Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
- Status
- Terminated
- Distribution
- US: AZ, AR, CA, CO, DC, FL, GA, IL, IN, IO, MD, MA, MI, MN, MO, NV, NJ, NY, NC, OH, OK, PA, TN, TX, UT, VA, WA OUS: China
- Enforcement report date
- Oct. 20, 2021
- 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
- Terminated (FDA's definition: FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Intuitive Surgical, Inc.
- Product
- Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978
- Reason
- Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
- Distribution pattern
- US: AZ, AR, CA, CO, DC, FL, GA, IL, IN, IO, MD, MA, MI, MN, MO, NV, NJ, NY, NC, OH, OK, PA, TN, TX, UT, VA, WA OUS: China
- Quantity
- 1625 units
- Codes and lots
- Affected Lot Number(s): S90200303, S90200622, S90200727, S90200811, S90200820, S90200831 ,S90200909, S90201008, S90201015 ,S90201103, S90201107, S90201125 ,S90201202, S90201204, S90210114 ,S90210211, S90210225, S90210310 ,S90210318, S90210408, S90210414
- Recall started
- Aug. 6, 2021
- Recall terminated (FDA)
- May 17, 2024
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Bronchoscope (Flexible Or Rigid)
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- On August 6, 2021, Intuitive Surgical issued an "Urgent Medical Device Recall" notice to affected consignees via Fed Ex. In addition to informing consignees about the recall, Intuitive ask consignees to take the following actions: 1. Inform necessary hospital personnel about this issue. 2. Inform affected personnel when the requested actions have been completed. 3. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. 4. Please retain a copy of this letter and the acknowledgement form for your files. 5. All returned affected product will be assessed and credit will be provided for the quantity returned. Intuitive will provide a follow up notification once unaffected product becomes available. 6. If you need further information or support concerning this Medical Device Notification, please contact your Endoluminal Sales Representative or contact Intuitive Customer Service at the numbers listed below: " North America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com.
- Recall number
- Z-0106-2022
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.
“Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.”Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978, FDA enforcement report, 2021-10-20. 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: Bronchoscope (Flexible Or Rigid)
Distributed in (FDA's record): Arizona Arkansas California Colorado District of Columbia Florida Georgia Illinois Indiana Maryland Massachusetts Michigan Minnesota Missouri Nevada New Jersey New York North Carolina Ohio Oklahoma Pennsylvania Tennessee Texas Utah Virginia Washington
This recall among the others
- FDA's enforcement report came 75 days after the firm started the recall. For half of the 892 FDA medical device recall events reported in 2021 with a start date, it took 50 days or fewer (by year).
- Intuitive Surgical: 15 other recalls or notices on this site in the three years before this one (from Oct. 21, 2018).
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 report, recall number Z-0106-2022. 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-0106-2022, Oct. 20, 2021. "Ion Flexison Biopsy Needle." PlainRecords, https://plainrecords.com/recall/device/z-0106-2022/ (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