Biosense Webster recalls
Biosense Webster appears in 33 official U.S. recall notices indexed by RecallRadar, most recently on 2025-03-12.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- VARIPULSE Bi-Directional Ablation Catheter REF D141201
FDA Device · Class I · 2025-03-12 · Biosense Webster - CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibili…
FDA Device · Class II · 2024-03-20 · Biosense Webster - Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
FDA Device · Class II · 2023-04-12 · Biosense Webster - Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
FDA Device · Class II · 2023-04-12 · Biosense Webster - CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501
FDA Device · Class II · 2022-09-14 · Biosense Webster - Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)108468…
FDA Device · Class II · 2021-03-31 · Biosense Webster - Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE EO, udi: (01)108468…
FDA Device · Class II · 2021-03-31 · Biosense Webster - Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)10846…
FDA Device · Class II · 2021-03-31 · Biosense Webster - PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Densi…
FDA Device · Class II · 2020-06-24 · Biosense Webster - PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-D…
FDA Device · Class II · 2020-06-24 · Biosense Webster - WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523
FDA Device · Class I · 2018-09-05 · Biosense Webster - PENTARAY NAV High-Density Mapping Catheter
FDA Device · Class II · 2017-12-13 · Biosense Webster - SMARTABLATE RF System Generator
FDA Device · Class II · 2017-12-13 · Biosense Webster - PENTARAY NAV High-Density Mapping Catheter
FDA Device · Class II · 2017-12-13 · Biosense Webster - THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
FDA Device · Class II · 2017-11-08 · Biosense Webster - THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S
FDA Device · Class II · 2017-11-08 · Biosense Webster - THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)
FDA Device · Class II · 2017-11-08 · Biosense Webster - THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)
FDA Device · Class II · 2017-11-08 · Biosense Webster - THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S
FDA Device · Class II · 2017-11-08 · Biosense Webster - CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CARTO…
FDA Device · Class II · 2016-09-21 · Biosense Webster - Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 The Biosense Webster Pentaray…
FDA Device · Class II · 2016-05-11 · Biosense Webster - Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 The Biosense Webster Penta…
FDA Device · Class II · 2016-05-11 · Biosense Webster - Carto 3 EP Navigation System
FDA Device · Class II · 2015-10-07 · Biosense Webster - SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters
FDA Device · Class II · 2015-10-07 · Biosense Webster - SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107
FDA Device · Class II · 2015-06-03 · Biosense Webster - WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure
FDA Device · Class II · 2015-05-06 · Biosense Webster - LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05, D-1354-06
FDA Device · Class II · 2015-03-11 · Biosense Webster - ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603
FDA Device · Class II · 2014-11-05 · Biosense Webster - PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205, D128207, D128208,…
FDA Device · Class II · 2014-03-19 · Biosense Webster - CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3
FDA Device · Class II · 2014-02-26 · Biosense Webster - 20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart
FDA Device · Class II · 2013-07-10 · Biosense Webster - 20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO…
FDA Device · Class II · 2013-04-03 · Biosense Webster - CARTO 3 V1.05(FG-5400-00)
FDA Device · Class II · 2012-09-19 · Biosense Webster