Brand recall history

Angiodynamics recalls

Every FDA recall record we found for Angiodynamics, newest first. Updated Oct. 11, 2026.

50 recalls since 2008. The most recent was on April 29, 2026.

Last 12 months: 1
Most recent: 2026-04
Most serious (FDA Class I): 0
Last 30 days: 0

Recalls by year

2012–2026

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Class I (FDA, most serious)Other recalls

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Recent recalls

1 of 50

April 29, 2026Class IIFDA · Medical device

Soft-Vu Angiographic Catheter… and 19 more products

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Filed by: Angiodynamics, Inc.

More recalls

March 26, 2025IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit… Class IIProduct is mislabeled with the incorrect fill volume.
Jan. 8, 2025Auryon Laser System 100-120 Vac… Class IIPotential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to…
Aug. 7, 2024SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic… and 1 more product Class IIMislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a…
July 10, 2024IsoLoc Prostate Immobilization Treatment Balloon Device Kit… Class IIA single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of…
May 15, 2024Duraflow 2… and 14 more products Class IITri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical…
March 27, 2024MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the… and 14 more products Class IINon-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass…
Feb. 14, 2024PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20… Class IIRotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.
April 19, 2023NanoKnife 5-Probe Procedure Pack 15 cm… Class IINot programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized…
Nov. 2, 2022Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray… Class IIPrinted Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and…
Oct. 5, 2022VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure… Class IIOPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimensional specification, may result in damage to the…
Oct. 13, 2021AngioDynamics NanoKnife Disposable Single Electrode Probes… Class IIProgramming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator.
Oct. 6, 2021Xcela PICC with PASV Valve Technology/Kit 5 F-55cm… Class IIMislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec).
Sept. 15, 2021Solero Generator Refurbished US PG… and 3 more products Class IISpecific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can…
April 28, 2021Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI… and 1 more product Class IIAngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for…
Nov. 11, 2020Angiodynamics 5F Standard Micro-Introducer Kit… Class II5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component
June 24, 2020BioFlo Midline Catheter and BioFlo Maximal Barrier Kits… and 3 more products Class IICertain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
Dec. 25, 2019Oartrac Prostate Immobilization Endorectal Balloon Device Kit… and 4 more products Class IIMay result in readings outside of the expected accuracy range.
Nov. 27, 2019Bioflo 8F Single Plastic Filled… and 4 more products Class IISnap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap…
Nov. 27, 2019Starburst Talon Semi-Flex Electrosurgical Device… Class IIThe devices are not labelled correctly. End users impacted by this issue may experience a procedural delay.
Sept. 11, 2019AngioDynamics VenaCure EVLT NeverTouch Procedure Kit… Class IIThe affected product is properly labelled with an expiration date of March 31, 2022; but the RFID programmed expiration date is April-2014 which…
June 12, 2019AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero… and 4 more products Class IIUpdated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a…
Dec. 19, 2018Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter… and 1 more product Class IISpecific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf…
Oct. 17, 2018BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED… Class IIBioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual sterile port assembly used was, 8F SL Xcela Plus…
June 20, 2018XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG… and 37 more products Class IIA component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
April 25, 2018Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive… Class IINAMIC Fluid Management Convenience Kits contains a Fluid Delivery Set that was not assembled in accordance with specification, and prevents the…
March 7, 2018Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015)… Class IIProduct was placed into distribution prior to completion of all required post sterilization release activities.
Feb. 14, 2018Accu2i pMTA Applicator… and 5 more products Class IIThe firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired…
Dec. 20, 2017Xcela PICC Kit with ENDEXO and PASV Valve Technology… and 12 more products Class IINavilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the…
April 26, 2017NAMIC Fluid Delivery Set… Class IIThe product has the potential to be non-sterile as it was not packaged in accordance to specification.
Feb. 15, 2017Celerity ECG Cable Accessory Pack… Class IIThe Celerity ECG Cable Accessory Pack has the potential to contain an ECG Clip Cable that was not properly manufactured. The affected product is not…
Dec. 28, 2016ANGIODYNAMICS Percutaneous Introducer Set under the following labels… and 6 more products Class IIGreatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016…
Dec. 14, 2016Peripherally Inserted Central Catheters (PICC)… and 1 more product Class IIThere is a potential for stylet stiffening that is not accurately represented on the labeling. The label states that product includes a stylet with…
Dec. 14, 2016Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal… and 2 more products Class IIMedline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem packing of the Maximal Barrier Nursing Kits. Medline…
June 1, 2016Vortex MEDICAL AngioVac Circuit… and 1 more product Class IIMaquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed…
April 13, 2016Namic Convenience Kit Self Regional Healthcare PV Leg Pack… and 3 more products Class IIProcedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specification. Specifically, at least a…
March 4, 2015Starburst MRI Semi-Flex Electrode Device… Class IIPrinted mark on the trocar intended to indicate a 5cm distance from the distal tip of the needle is actually located 4cm from the distal tip of the…
Aug. 27, 2014Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE… and 2 more products Class IIAngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).
July 17, 2013AngioDynamics RITA Main Cable… Class IIThe RITA Main Cable product contains the incorrect Instructions for Use.
June 5, 2013AngioDynamics Micro Introducer Kits under the following labeling: 1)… and 1 more product Class IIAngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro…
Jan. 11, 2012DURAMAX 15.5 F x 22 cm Chronic Hemodialysis Catheter Set (With Cuff… and 4 more products AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use.
Oct. 13, 20118F Safe Sheath Introducer… and 1 more product The product may contain an incorrect size catheter and introducer.
Sept. 23, 2011Angiodynamics Nanoknife Ire Generator… Some units of Nanoknife have the potential to deliver a shortened pulse width without indicating an error. The affected units contain a "GOMe"…
Aug. 24, 2011Vortex MP Port Single Titanium Port with Attached (5Fr) Silicone… and 3 more products The labeling contains errors which result in the products being misbranded
Nov. 17, 2010Vortex VX Port… and 4 more products Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit contains a Lifeguard Safety Infusion Set.
June 4, 2010DURAMAX (TM) Hemodialysis Catheters… and 10 more products The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform the leak test on the DuraMax Catheters was…
May 28, 2010ANGIODYNAMICS BENEPHIT(TM) XT Infusion System… and 1 more product Benephit Infusion Catheters may exhibit a hole or tear in the primary sterile barrier packaging. The product is intended to be sterile. Breaches in…
May 27, 2010Pulsespray Infusion System… This lot was packaged with the wrong occluding ball guidewire. The PulseSpray Catheter is 90 cm in length and requires a 109 cm occluding ball…
Sept. 1, 2009SmartPort CT Port Access System… The product may contain an incorrect size catheter and introducer.
Sept. 24, 2008Centros(TM) 15F x 24cm Chronic Hemodialysis Curved Catheter Set (With… and 2 more products The cuff may be inadequately attached to the catheter, resulting in possible catheter movement or leakage at the insertion site.

How we match: a recall is listed here when the agency names Angiodynamics as the company that filed it. Sources: FDA enforcement reports and FDA-posted company announcements, CPSC recall notices and NHTSA recall campaigns.

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