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Biosense Webster, Inc.

45 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated fo recall (Z-1205-2025)Biosense Webster, Inc.2025-02-28
CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional recall (Z-1290-2024)Biosense Webster, Inc.2024-03-13
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, recall (Z-1319-2023)Biosense Webster, Inc.2023-04-01
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S recall (Z-1320-2023)Biosense Webster, Inc.2023-04-01
CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Softw recall (Z-2776-2016)Biosense Webster, Inc.2016-09-09
Carto 3 EP Navigation System. Electro physiology system which views of the electrical acti recall (Z-0002-2016)Biosense Webster, Inc.2015-10-01
SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-lumi recall (Z-0003-2016)Biosense Webster, Inc.2015-10-01
SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107. Pro recall (Z-1691-2015)Biosense Webster, Inc.2015-05-28
WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac s recall (Z-1525-2015)Biosense Webster, Inc.2015-04-27
LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, recall (Z-1242-2015)Biosense Webster, Inc.2015-03-03
ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704 recall (Z-0139-2015)Biosense Webster, Inc.2014-10-27
PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128 recall (Z-1176-2014)Biosense Webster, Inc.2014-03-11
CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-1 recall (Z-1045-2014)Biosense Webster, Inc.2014-02-20
20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysio recall (Z-1617-2013)Biosense Webster, Inc.2013-06-28
20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended t recall (Z-1023-2013)Biosense Webster, Inc.2013-03-28
CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial recall (Z-2369-2012)Biosense Webster, Inc.2012-09-12
EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional Catheter Cardiovascular recall (Z-1647-2012)Biosense Webster, Inc.2012-05-22
CARTO 3 Systems, Product Code M-4800-01 The intended use of the CARTO 3 System is catheter recall (Z-1230-2012)Biosense Webster, Inc.2012-03-20
EZ Steer ThermoCool Nav Part Number D-1292-01-S Diagnostic/Ablation Catheter instructions recall (Z-0979-2012)Biosense Webster, Inc.2012-02-07
EZ Steer ThermoCool Nav Part Number D-1292-02-S Diagnostic/Ablation Catheter instructions recall (Z-0980-2012)Biosense Webster, Inc.2012-02-07
EZ Steer ThermoCool Nav Part Number D-1292-03-S Diagnostic/Ablation Catheter instructions recall (Z-0981-2012)Biosense Webster, Inc.2012-02-07
EZ Steer ThermoCool Nav Part Number D-1292-04-S Diagnostic/Ablation Catheter instructions recall (Z-0982-2012)Biosense Webster, Inc.2012-02-07
EZ Steer ThermoCool Nav Part Number D-1292-05-S Diagnostic/Ablation Catheter instructions recall (Z-0983-2012)Biosense Webster, Inc.2012-02-07
STOCKERT 70 Radio Frequency Generator, Catalog Number 57001 Indicated for use with a Biose recall (Z-3178-2011)Biosense Webster, Inc.2011-09-12
ISMUS Catheter Mapping Catheter with Auto ID Technology, Manufacturing Part Number D-1171- recall (Z-3037-2011)Biosense Webster, Inc.2011-08-18
Duo-Decapolar Electrophysiology Catheter, Manufacturing Part Number D-1171-35-S, Catalog N recall (Z-3038-2011)Biosense Webster, Inc.2011-08-18
ISMUS CATH Mapping Catheter with Auto ID Technology, Part Number D-1171-34-S, Catalog # D7 recall (Z-2664-2011)Biosense Webster, Inc.2011-06-27
HALO Catheter with Auto 10 Technology, Part Number D-1160-43-S, Catalog Number D7T20282CT recall (Z-2665-2011)Biosense Webster, Inc.2011-06-27
LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers D-122081 recall (Z-2666-2011)Biosense Webster, Inc.2011-06-27
LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers D-1220-8 recall (Z-2667-2011)Biosense Webster, Inc.2011-06-27
10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue, Manufacturing Part Nu recall (Z-1839-2011)Biosense Webster, Inc.2011-03-28
CARTO 3 System Interface Cable, 34-pin to 10-pin, Red, 10' - Part Number: D-1286-18; Catal recall (Z-0884-2011)Biosense Webster, Inc.2011-01-07
Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 4mm Catheters; Part Number recall (Z-0368-2010)BioSense Webster, Inc.2009-11-19
Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 8mm DS Catheters; Part Num recall (Z-0369-2010)BioSense Webster, Inc.2009-11-19
Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping Catheter- recall (Z-1703-2008)Biosense Webster Inc2008-08-25
Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping Catheter- recall (Z-1704-2008)Biosense Webster Inc2008-08-25
Biosense Webster PREFACE Guiding Sheath, Multipurpose Short, for the introduction of intra recall (Z-0537-2007)Biosense Webster, Inc.2007-02-28
Biosense Webster PREFACE Guiding Sheath, Multipurpose 62cm, for the introduction of intrav recall (Z-0538-2007)Biosense Webster, Inc.2007-02-28
Biosense Webster PREFACE Guiding Sheath, Multipurpose 77cm, for the introduction of intrav recall (Z-0539-2007)Biosense Webster, Inc.2007-02-28
Biosense Webster PREFACE Guiding Sheath, Anterior, for the introduction of intravascular e recall (Z-0540-2007)Biosense Webster, Inc.2007-02-28
Biosense Webster PREFACE Guiding Sheath, Posterior, for the introduction of intravascular recall (Z-0541-2007)Biosense Webster, Inc.2007-02-28
Thermocool Irrigated Catheters Celsius LABEL US Part Number# EU CATALOG # L-1189-01-S D17T recall (Z-0057-06)Biosense Webster, Inc.2005-10-15
Deflectable Tip Catheter for cardiac mapping. Mfg Part # Catalog # EU Part # D-1078-35-S 1 recall (Z-1437-04)Biosense Webster, Inc.2004-09-02
Stockert 70 Radio Frequency Ablation Generator recall (Z-1328-04)Biosense Webster, Inc.2004-08-07
Quickcable Autoclaveable Cable Electrode Cable recall (Z-1006-04)Biosense Webster, Inc.2004-07-20

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