Biosense Webster, Inc.
Irwindale, 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.
52
Total Recalls
2004
First Recall
2022
Most Recent
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular cathe...
Jun 29, 2022
· Device
Open, Classified
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 279...
Feb 26, 2021
· Device
Completed
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797...
Feb 26, 2021
· Device
Completed
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797...
Feb 26, 2021
· Device
Completed
WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
May 7, 2018
· Device
Terminated
THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S
Sep 6, 2017
· Device
Terminated
THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
Sep 6, 2017
· Device
Terminated
THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)
Sep 6, 2017
· Device
Terminated
THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S
Sep 6, 2017
· Device
Terminated
THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)
Sep 6, 2017
· Device
Terminated
SMARTABLATE RF System Generator
Jun 14, 2017
· Device
Terminated
PENTARAY NAV High-Density Mapping Catheter.
May 17, 2017
· Device
Terminated
PENTARAY NAV High-Density Mapping Catheter.
May 17, 2017
· Device
Terminated
CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2...
Sep 9, 2016
· Device
Terminated
Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206...
Apr 14, 2016
· Device
Terminated
Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D1282...
Apr 14, 2016
· Device
Terminated
Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart th...
Oct 1, 2015
· Device
Terminated
SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization o...
Oct 1, 2015
· Device
Terminated
SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107.
Product Usage:
The use...
May 28, 2015
· Device
Terminated
WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stim...
Apr 27, 2015
· Device
Terminated
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...
Mar 3, 2015
· Device
Terminated
ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601,...
Oct 27, 2014
· Device
Terminated
PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D12820...
Mar 11, 2014
· Device
Terminated
CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124
WITH THE CARTOUN...
Feb 20, 2014
· Device
Terminated
20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S.
Designed to facilitate electrophysiological mapping of...
Jun 28, 2013
· Device
Terminated
20-Pole Eco Cable, Catalog #EM-5050-060
Product Usage:
The 20-Pole Eco Cable is intended to be used as an int...
Mar 28, 2013
· Device
Terminated
CARTO 3 V1.05(FG-5400-00).
The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular map...
Sep 12, 2012
· Device
Terminated
EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional Catheter
Cardiovascular catheter for use in...
May 22, 2012
· Device
Terminated
CARTO 3 Systems, Product Code M-4800-01
The intended use of the CARTO 3 System is catheter-based cardiac elec...
Mar 20, 2012
· Device
Terminated
EZ Steer ThermoCool Nav Part Number D-1292-05-S Diagnostic/Ablation Catheter instructions for use.
The Bios...
Feb 7, 2012
· Device
Terminated
EZ Steer ThermoCool Nav Part Number D-1292-02-S Diagnostic/Ablation Catheter instructions for use.
The Bios...
Feb 7, 2012
· Device
Terminated
EZ Steer ThermoCool Nav Part Number D-1292-04-S Diagnostic/Ablation Catheter instructions for use.
The Bios...
Feb 7, 2012
· Device
Terminated
EZ Steer ThermoCool Nav Part Number D-1292-03-S Diagnostic/Ablation Catheter instructions for use.
The Bios...
Feb 7, 2012
· Device
Terminated
EZ Steer ThermoCool Nav Part Number D-1292-01-S Diagnostic/Ablation Catheter instructions for use.
The Bios...
Feb 7, 2012
· Device
Terminated
STOCKERT 70 Radio Frequency Generator, Catalog Number 57001
Indicated for use with a Biosense Webster, Inc....
Sep 12, 2011
· Device
Terminated
Duo-Decapolar Electrophysiology Catheter, Manufacturing Part Number D-1171-35-S, Catalog Number D728260RT
Duo...
Aug 18, 2011
· Device
Terminated
ISMUS Catheter Mapping Catheter with Auto ID Technology, Manufacturing Part Number D-1171-34-S, Catalog Number...
Aug 18, 2011
· Device
Terminated
ISMUS CATH Mapping Catheter with Auto ID Technology, Part Number D-1171-34-S, Catalog #
D7R20P14CT
The affect...
Jun 27, 2011
· Device
Terminated
LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers D-1220-82-S, Catalog Numbers...
Jun 27, 2011
· Device
Terminated
HALO Catheter with Auto 10 Technology, Part Number D-1160-43-S, Catalog Number
D7T20282CT
The affected cathet...
Jun 27, 2011
· Device
Terminated
LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers D-122081-
S, Catalog Numbers...
Jun 27, 2011
· Device
Terminated
10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue, Manufacturing Part Number 01287-09, Catal...
Mar 28, 2011
· Device
Terminated
CARTO 3 System Interface Cable, 34-pin to 10-pin, Red, 10' - Part Number: D-1286-18; Catalog Number CR3410CT
T...
Jan 7, 2011
· Device
Terminated
Biosense Webster PREFACE Guiding Sheath, Posterior, for the introduction of intravascular electrophysiology ca...
Feb 28, 2007
· Device
Terminated
Biosense Webster PREFACE Guiding Sheath, Anterior, for the introduction of intravascular electrophysiology cat...
Feb 28, 2007
· Device
Terminated
Biosense Webster PREFACE Guiding Sheath, Multipurpose 77cm, for the introduction of intravascular electrophysi...
Feb 28, 2007
· Device
Terminated
Biosense Webster PREFACE Guiding Sheath, Multipurpose Short, for the introduction of intravascular electrophys...
Feb 28, 2007
· Device
Terminated
Biosense Webster PREFACE Guiding Sheath, Multipurpose 62cm, for the introduction of intravascular electrophysi...
Feb 28, 2007
· Device
Terminated
Thermocool Irrigated Catheters
Celsius
LABEL US Part Number# EU CATALOG #
L-1189-01-S D17TCBLRT 35Q-13R PMA;...
Oct 15, 2005
· Device
Terminated
Deflectable Tip Catheter for cardiac mapping.
Mfg Part # Catalog # EU Part #
D-1078-3...
Sep 2, 2004
· Device
Terminated