Medical DeviceMar 12, 2025
Biosense Webster VARIPULSE Bi-Directional Ablation Catheter REF D141201 recall — FDA Z-1205-2025
Due to an observed trend of neurovascular events
Class IFDA: OngoingBiosense Webster, Inc.
Recall history in this database
Classification mix: Class II: 1, Class I: 1.
Medical DeviceMar 20, 2024
Biosense Webster CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM recall — FDA Z-1290-2024
Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.
Class IIFDA: OngoingBiosense Webster, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Biosense Webster, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.