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Biosense Webster, Inc. Recalls

22 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Biosense Webster, Inc..

22Total Recalls
1Critical
411,975Units Affected
Feb 16, 2024Most Recent
All Recalls

Every Biosense Webster, Inc. Recall

Sorted by most recent. Click any recall for full details.

22 recalls
High RiskFDA
Biosense Webster, Inc.
CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide acces...
Cardiac Devices·853 affected·Feb 16, 2024
High RiskFDA
Biosense Webster, Inc.
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
Medical Devices·277 affected·Feb 21, 2023
High RiskFDA
Biosense Webster, Inc.
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE EO, udi: (01)1084...
Cardiac Devices·0 affected·Feb 26, 2021
High RiskFDA
Biosense Webster, Inc.
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)1084...
Cardiac Devices·71,473 affected·Feb 26, 2021
High RiskFDA
Biosense Webster, Inc.
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)108...
Cardiac Devices·0 affected·Feb 26, 2021
CriticalFDA
Biosense Webster, Inc.
WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
Medical Devices·25 affected·May 7, 2018
High RiskFDA
Biosense Webster, Inc.
THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
Surgical Devices·329 affected·Sep 6, 2017
High RiskFDA
Biosense Webster, Inc.
THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S
Medical Devices·357 affected·Sep 6, 2017
High RiskFDA
Biosense Webster, Inc.
SMARTABLATE RF System Generator
Medical Devices·185 affected·Jun 14, 2017
High RiskFDA
Biosense Webster, Inc.
PENTARAY NAV High-Density Mapping Catheter.
Surgical Devices·73,796 affected·May 17, 2017
High RiskFDA
Biosense Webster, Inc.
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 CA...
Cardiac Devices·338 affected·Aug 15, 2016
High RiskFDA
Biosense Webster, Inc.
Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 The Biosense Webster Pent...
Cardiac Devices·13,912 affected·Apr 14, 2016
High RiskFDA
Biosense Webster, Inc.
Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 The Biosense Webster ...
Cardiac Devices·59,672 affected·Apr 14, 2016
High RiskFDA
Biosense Webster, Inc.
SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel ...
Cardiac Devices·1,035 affected·Sep 10, 2015
High RiskFDA
Biosense Webster, Inc.
SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107. Product Usage: The use of the SMART ABLATE Gen...
Cardiac Devices·115 affected·Mar 19, 2015
High RiskFDA
Biosense Webster, Inc.
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. LASSO NAV DUO LOOP eco C...
Cardiac Devices·464 affected·Feb 25, 2015
High RiskFDA
Biosense Webster, Inc.
ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
Surgical Devices·173,329 affected·Oct 19, 2014
High RiskFDA
Biosense Webster, Inc.
PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205, D128207, D12820...
Cardiac Devices·15,672 affected·Feb 20, 2014
High RiskFDA
Biosense Webster, Inc.
CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124 WITH THE CARTOUNIVU MODULE, FLUOROSCOPIC ...
Surgical Devices·8 affected·Feb 12, 2014
High RiskFDA
Biosense Webster, Inc.
20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.
Cardiac Devices·10 affected·Jun 19, 2013
High RiskFDA
Biosense Webster, Inc.
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...
Surgical Devices·54 affected·Mar 5, 2013
High RiskFDA
Biosense Webster, Inc.
CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system ...
Cardiac Devices·71 affected·Nov 17, 2009