Recall Atlas

Biosense Webster recalls

4 official recalls and safety alerts involving Biosense Webster since 2022-09, 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 Biosense Webster or the relevant agency.

  1. 2025-03-12
  2. US
    Drugs & medicalClass I

    Biosense Webster, Inc. recalls VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac…

    Due to an observed trend of neurovascular events

    FDA · DeviceBiosense Webster, Inc.Worldwide distribution; US states of AR, CA, CO, KS, LA, MA, MO, NY, OH and…Official notice →
  3. 2024-03-20
  4. US
    Drugs & medicalClass II

    Biosense Webster, Inc. recalls CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide…

    Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.

    FDA · DeviceBiosense Webster, Inc.U.S. Nationwide distribution including in the states of FL, IL, AL, NY, PA,…Official notice →
  5. 2023-04-12
  6. US
    Drugs & medicalClass II

    Biosense Webster, Inc. recalls Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile

    Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch

    FDA · DeviceBiosense Webster, Inc.Worldwide distribution - US Nationwide distribution including the states of…Official notice →
  7. 2022-09-14
  8. US
    Drugs & medicalClass II

    Biosense Webster, Inc. recalls CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.

    Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile barrier of the product inside. Devices with a compromised…

    FDA · DeviceBiosense Webster, Inc.US Nationwide distribution in the states of AL, GA, AZ, TX, MA, VA, NY, ME,…Official notice →