Recall Atlas

ev3 recalls

3 official recalls and safety alerts involving ev3 since 2022-01, 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 ev3 or the relevant agency.

  1. 2025-01-22
  2. US
    Drugs & medicalClass II

    ev3 Inc recalls Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X…

    There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.

    FDA · Deviceev3 IncWorldwide distribution - US (& PR) Nationwide and the countries of Chile,…Official notice →
  3. 2022-03-16
  4. US
    Drugs & medicalClass I

    ev3 Inc. recalls Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.

    The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.

    FDA · Deviceev3 Inc.US Nationwide distribution in the states of AZ, CA, FL, IA, IL, KS, LA, MI,…Official notice →
  5. 2022-01-26
  6. US
    Drugs & medicalClass I

    ev3 Inc. recalls Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014"…

    Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.

    FDA · Deviceev3 Inc.Worldwide Distribution: US (nationwide), including PR; and Foreign…Official notice →