Biosense Webster, Inc.
Irvine, CA
This page shows every FDA and USDA recall linked to Biosense Webster, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
4
Total Recalls
2023
First Recall
2025
Most Recent
VARIPULSE Bi-Directional Ablation Catheter REF D141201.
The Field Catheter is indicated for use in cathete...
Feb 28, 2025
· Device
Open, Classified
CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502
The CARTO VIZIGOTM Bi-Directional Guiding Sheath is...
Mar 13, 2024
· Device
Open, Classified
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Steril...
Apr 1, 2023
· Device
Open, Classified
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
Apr 1, 2023
· Device
Open, Classified