Angiodynamics recalls
14 official recalls and safety alerts involving Angiodynamics since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Angiodynamics or the relevant agency.
- 2026-04-29
USAngiodynamics, Inc. recalls Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145…
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.
FDA · DeviceAngiodynamics, Inc.Worldwide distribution - US Nationwide and the countries of Austria,…Official notice →- 2025-03-26
- US
Angiodynamics, Inc. recalls IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Product is mislabeled with the incorrect fill volume.
FDA · DeviceAngiodynamics, Inc.US Nationwide distribution in the states of AZ, DC, FL, TN, TX, VA, WI.Official notice → - 2025-01-08
- US
Angiodynamics, Inc. recalls AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to the Activation (Ready) mode.
FDA · DeviceAngiodynamics, Inc.US Nationwide distribution to the states of AR, AZ, CA, CO, CT, FL, GA, IL,…Official notice → - 2024-08-07
- US
Angiodynamics, Inc. recalls SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702
Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)
- 2024-07-10
- US
Angiodynamics, Inc. recalls IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but the inner pouch identifies the product as an ISO-60 (fill…
FDA · DeviceAngiodynamics, Inc.US Nationwide distribution in the states of AZ, FL, IL, MO, MS, NJ, NM, NY,…Official notice → - 2024-05-15
- US
- US
Angiodynamics, Inc. recalls DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product…
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
- 2024-03-27
- US
Angiodynamics, Inc. recalls MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system.…
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the…
FDA · DeviceAngiodynamics, Inc.Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ,…Official notice → - 2024-02-14
- US
Angiodynamics, Inc. recalls PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN:…
Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.
FDA · DeviceAngiodynamics, Inc.United States (MD, LA & UT), Austria, Canada and Spain.Official notice → - 2023-04-19
- US
Angiodynamics, Inc. recalls NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN:…
Not programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized by the NanoKnife generator resulting in a delay in procedure
- 2022-11-02
- US
Angiodynamics, Inc. recalls Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central venous placement…
Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for the Preparation, Implantation, and Post Operative Care of…
FDA · DeviceAngiodynamics, Inc.US Nationwide distribution in the states of AZ, CA, DC, IN, PA.Official notice → - 2022-10-05
- US
Angiodynamics, Inc. recalls VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). For use in the…
OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimensional specification, may result in damage to the sheath, including separation or the inability to move the fiber within…
FDA · DeviceAngiodynamics, Inc.US Nationwide distribution in the states of FL, NC, NJ, NM, NY, PA, TX, VA.Official notice → - 2021-10-13
- US
Angiodynamics, Inc. recalls AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID…
Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator.
FDA · DeviceAngiodynamics, Inc.Internationally distribution to the countries of Australia, Germany, Denmark,…Official notice → - 2021-10-06
- US
Angiodynamics Inc. (Navilyst Medical Inc.) recalls Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term…
Mislabeled: 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).