Biosense Webster, Inc.
Medical device manufacturer in Irvine, CA.
76510(k) clearances
8PMA approvals
58recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K252972 | CARTO 3 EP Navigation System V8.4DQK · Traditional | 02/20/2026SE |
| K254085 | CARTO 3 EP Navigation System V9.0 with PIU PlusDQK · Special | 01/18/2026SE |
| K252302 | CARTO 3 EP Navigation System V8.1DQK · Special | 08/22/2025SE |
| K241540 | NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound CatheterOBJ · Special | 06/28/2024SE |
| K240050 | SOUNDSTAR CRYSTAL Ultrasound CatheterOBJ · Special | 06/12/2024SE |
| K231207 | CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)DQK · Traditional | 09/07/2023SE |
| K231412 | CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)DYB · Special | 07/10/2023SE |
| K231312 | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS…MTD · Special | 07/10/2023SE |
| K230253 | OPTRELL Mapping Catheter with TRUEref TechnologyMTD · Special | 03/02/2023SE |
| K223766 | NUVISION NAV Ultrasound CatheterOBJ · Traditional | 02/16/2023SE |
| K223733 | CARTO® 3 EP Navigation System with CARTOSOUND 4D Version 7.4DQK · Traditional | 02/16/2023SE |
| K221112 | CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)DQK · Traditional | 08/17/2022SE |
| K211438 | OPTRELL Mapping Catheter with TRUEref TechnologyMTD · Traditional | 03/18/2022SE |
| K211219 | LASSOSTAR NAV Circular Mapping CatheterDRF · Traditional | 01/26/2022SE |
| K213264 | CARTO 3 EP Navigation System Version 7.2DQK · Special | 10/29/2021SE |
| K200484 | CARTO® 3 EP Navigation System with Signal Processing UnitDQK · Traditional | 11/25/2020SE |
| K201750 | Pentaray Nav eco High-Density Mapping CatheterMTD · Traditional | 08/06/2020SE |
| K193237 | Carto Octaray Mapping Catheter with Trueref TechnologyMTD · Traditional | 07/31/2020SE |
| K193632 | LassoStar Circular Mapping CatheterDRF · Traditional | 06/30/2020SE |
| K192397 | TruDi Navigation SystemPGW · Traditional | 01/30/2020SE |
| K191660 | CARTO 3 EP Navigation System, Version 7.1 and AccessoriesDQK · Special | 07/20/2019SE |
| K173978 | CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER ModuleDQK · Traditional | 08/24/2018SE |
| K173977 | CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP ModuleDQK · Traditional | 06/14/2018SE |
| K180238 | CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINTDQK · Traditional | 06/01/2018SE |
| K170997 | CARTO VIZIGO 8.5F Bi-Directional Guiding SheathDYB · Traditional | 07/25/2017SE |
| K170600 | CARTO 3 EP Navigation System, Version 6.0 and AccessoriesDQK · Traditional | 07/25/2017SE |
| K161701 | CARTO ENT SystemPGW · Traditional | 10/24/2016SE |
| K133916 | Carto 3 Ep Navigation System, Version 4.2DQK · Traditional | 07/01/2014SE |
| K140318 | Soundstar Eco 8F Gultrasound Catheter, Soundstar Eco 8F Ultrasound CatheterOBJ · Special | 03/12/2014SE |
| K132782 | CARTO3 Ep Navigation System, Version 3.2DQK · Traditional | 01/24/2014SE |
| K130602 | Lasso Nav Duo Loop CatheterDRF · Traditional | 08/14/2013SE |
| K123837 | Pentaray Nav Eco High-Density Mapping CatheterMTD · Special | 03/05/2013SE |
| K120425 | Pentaray Nav High-Density Mapping CatheterMTD · Traditional | 05/24/2012SE |
| K120550 | Carto(R) Ep Navigation System, Version 3.0 (with Standard Location Pad)DQK · Traditional | 05/07/2012SE |
| K113213 | Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter Continued From Line 2DRF · Special | 12/05/2011SE |
| K112050 | Soundstar Eco Diagnostic Ultrasound CatheterOBJ · Special | 11/18/2011SE |
| K112007 | Carto 3 Ep Navigation System, Version 2.2DQK · Special | 10/05/2011SE |
| K101991 | Webster Duo-Decapolar CatheterDRF · Traditional | 05/02/2011SE |
| K103746 | Carto 3 Ep Navigation System, Version 2.0 (W/Standard Location PAD),CARTO3 Epnavigation…DQK · Special | 01/21/2011SE |
| K101345 | Webster CS Catheter with Ez Steer Technology, Webster CS Catheter with Ez Steer…DRF · Traditional | 06/22/2010SE |
| K101138 | Soundstar 3D Ultrasound Catheter Model M-5723-12OBJ · Special | 06/22/2010SE |
| K093566 | Carto XP Ep Navigation System, Version 10DQK · Traditional | 06/18/2010SE |
| K093376 | Lasso Nav CatheterDRF · Traditional | 06/18/2010SE |
| K093455 | Carto 3 Version 1.05 Ep Navigation System and AccessoriesDQK · Special | 12/04/2009SE |
| K091352 | Soundstar 3D Diagnostic Catheter, Model M-5723-05OBJ · Special | 12/04/2009SE |
| K090017 | Carto 3 Ep Navigation System, V1.0 and AccessoriesDQK · Traditional | 10/13/2009SE |
| K091789 | Carto RMT Ep Navigation System V8DQK · Traditional | 10/01/2009SE |
| K090898 | Coronary Sinus Deflectable Mapping Catheter, Model D-1263-01, Webster CS Catheter with…DRF · Special | 09/04/2009SE |
| K092064 | Soundstar 3D Ultrasound Catheter, Model M-5723-12OBJ · Special | 08/07/2009SE |
| K090120 | Refstar Plus with Qwikpatch External Reference Patch, Model D-1210-03, Refstar Plus…DRF · Special | 03/24/2009SE |
| K081258 | Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02DRF · Traditional | 01/06/2009SE |
| K080425 | CS Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02DRF · Traditional | 04/23/2008SE |
| K072202 | Carto 3 Navigation System (MODEL:FG-5400-00), Carto 3 External Reference Patches…DQK · Traditional | 11/19/2007SE |
| K070242 | Soundstar 3D Ultrasound Catheter, Model M-5723-05OBJ · Traditional | 05/15/2007SE |
| K070240 | Carto XP Ep Navigation System, Version 9DQK · Traditional | 05/04/2007SE |
| K061468 | Refstar External Reference PatchDRF · Special | 08/14/2006SE |
| K061463 | Esophageal Mapping Catheter, Model D-1272-01-SDRF · Traditional | 08/14/2006SE |
| K060047 | Carto RMT Ep Navigation System V8DRF · Traditional | 06/19/2006SE |
| K053194 | Noga XP Cardiac Navigation System with Qwikmap SoftwareDQK · Traditional | 03/09/2006SE |
| K052083 | Navistar RMT Steerable Tip Diagnostic CatheterDRF · Traditional | 09/29/2005SE |
| K042998 | Refstar RMT External Reference PatchDRF · Special | 09/29/2005SE |
| K042681 | Carto RMT Ep Navigation SystemDQK · Traditional | 09/29/2005SE |
| K050877 | Coronary Sinus Deflectable Mapping Catheter, 4 FR, 5 FR, 6 FR & 7 FRDRF · Special | 06/24/2005SE |
| K050217 | Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing), (2-6-2 MM Electrode…MTD · Traditional | 03/30/2005SE |
| K042999 | Carto XP Ep Navigation System, Software Verison 8DQK · Traditional | 03/21/2005SE |
| K031161 | Variable Lasso 2515 Circular Mapping CatheterDRF · Special | 07/22/2003SE |
| K020863 | Carto XP and Qwikmap Ep Navigation SystemDQK · Special | 01/09/2003SE |
| K013083 | Carto XP Ep Navigation SystemDQK · Special | 11/21/2001SE |
| K002333 | Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model D-1220DRF · Special | 08/31/2000SE |
| K001390 | Biosense Webster Patient Cable and LeadwiresDSA · Abbreviated | 07/21/2000SE |
| K001139 | Preface Guiding Sheath, Models 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103MDYB · Special | 05/10/2000SE |
| K000248 | Carto Ep Navigation SystemDQK · Special | 05/05/2000SE |
| K000190 | Modification to Carto Ep Navigation SystemDQK · Special | 05/05/2000SE |
| K000332 | Noga Cardiac Navigation SystemDQK · Special | 05/04/2000SE |
| K993729 | Modification to Carto Ep Navigation SystemDQK · Special | 12/03/1999SE |
| K992968 | Carto Ep Navigation SystemDQK · Special | 09/29/1999SE |
PMA approvals
- P240006 VARIPULSE Platform (VARIPULSE Catheter; TRUPULSE Generator; Sterile Interface Cable; nGEN Pump) · 11/06/2024 · 15 supplements
- P210027 QDOT MICRO System · 11/23/2022 · 17 supplements
- P040036 Navistar Thermocool Deflectable Diagnostic/Ablation Catheter · 08/11/2006 · 91 supplements
- P030031 Biosense Webster Navistar/Celsius Thermo Cool Diagnostic/Ablation Deflectable Tip Catheters · 11/05/2004 · 134 supplements
- P010068 Navistar/Celsius DS Diagnostic/Ablation Deflectable 8MM Tip Catheter · 09/27/2002 · 73 supplements
- P990025 Navi-Star Diagnostic/Ablation Deflectable Tip Catheter · 06/15/2000 · 72 supplements
- P990071 Stockert 70 Radiofrequency Ablation Generator · 05/31/2000 · 65 supplements
- P950005 Webster Diag./Ablation Deflectable Tip Catheter · 09/30/1997 · 86 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1205-2025 Class I | VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated…Due to an observed trend of neurovascular events | 01/05/2025Completed |
| Z-1290-2024 Class II | CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM…Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main… | 02/16/2024Open, Classified |
| Z-1320-2023 Class II | Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF…Incorrect labeling; specifically, the product name, lot number and product code on the carton label for… | 02/21/2023Open, Classified |
| Z-1319-2023 Class II | Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF…Incorrect labeling; specifically, the product name, lot number and product code on the carton label for… | 02/21/2023Open, Classified |
| Z-1677-2022 Class II | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various…Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained… | 06/29/2022Open, Classified |
| Z-1287-2021 Class II | Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF:…There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the… | 02/26/2021Completed |
| Z-1286-2021 Class II | Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF:…There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the… | 02/26/2021Completed |
| Z-1285-2021 Class II | Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF:…There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the… | 02/26/2021Completed |
| Z-2372-2020 Class II | PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO -…Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to… | 04/22/2020Terminated |
| Z-2371-2020 Class II | PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product…Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to… | 04/22/2020Terminated |
| Z-2878-2018 Class I | WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523…When attempting to recapture the 32-mm device, the tip of the delivery sheath may fold or buckle, resulting… | 05/07/2018Terminated |
| Z-0058-2018 Class II | THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-SBiosense Webster, Inc. has recently received an increased number of complaints related to the display of… | 09/06/2017Terminated |
| Z-0057-2018 Class II | THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)Biosense Webster, Inc. has recently received an increased number of complaints related to the display of… | 09/06/2017Terminated |
| Z-0056-2018 Class II | THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)Biosense Webster, Inc. has recently received an increased number of complaints related to the display of… | 09/06/2017Terminated |
| Z-0055-2018 Class II | THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S…Biosense Webster, Inc. has recently received an increased number of complaints related to the display of… | 09/06/2017Terminated |
| Z-0054-2018 Class II | THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S…Biosense Webster, Inc. has recently received an increased number of complaints related to the display of… | 09/06/2017Terminated |
| Z-0210-2018 Class II | SMARTABLATE RF System GeneratorGenerator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented… | 06/14/2017Terminated |
| Z-0212-2018 Class II | PENTARAY NAV High-Density Mapping Catheter.Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters… | 05/17/2017Terminated |
| Z-0211-2018 Class II | PENTARAY NAV High-Density Mapping Catheter.Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters… | 05/17/2017Terminated |
| Z-2776-2016 Class II | CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C…Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Systems that… | 08/15/2016Terminated |
| Z-1591-2016 Class II | Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209…Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the… | 04/14/2016Terminated |
| Z-1590-2016 Class II | Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203…Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the… | 04/14/2016Terminated |
| Z-0003-2016 Class II | SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and…Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting… | 09/10/2015Terminated |
| Z-0002-2016 Class II | Carto 3 EP Navigation System. Electro physiology system which views of the electrical…Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting… | 09/10/2015Terminated |
| Z-1525-2015 Class II | WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac…The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation… | 04/17/2015Terminated |
| Z-1691-2015 Class II | SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107.…Biosense Webster is recalling the SMARTABLATE Generator System because Biosense Webster has received two… | 03/19/2015Terminated |
| Z-1242-2015 Class II | LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03…Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty… | 02/25/2015Terminated |
| Z-0139-2015 Class II | ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703…The recall was initiated because Biosense Webster is providing additional labeling for the safe and… | 10/19/2014Terminated |
| Z-1176-2014 Class II | PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No.…Biosense Webster is recalling the PentaRay Nav Catheter because it has the potential to have partial tip… | 02/20/2014Terminated |
| Z-1045-2014 Class II | CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No.…Biosense Webster has initiated a recall of the CartoUnivu Module within the Carto 3 System (V3.2.2 and… | 02/12/2014Terminated |
| Z-1617-2013 Class II | 20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate…Biosense Webster is recalling the 20-Pole LASSO NAV Catheter Eco because it has been incorrectly calibrated… | 06/19/2013Terminated |
| Z-1023-2013 Class II | 20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended…Biosense is recalling the 20-Pole Eco Cable because it was incorrectly calibrated. When a catheter is… | 03/05/2013Terminated |
| Z-1230-2012 | CARTO 3 Systems, Product Code M-4800-01 The intended use of the CARTO 3 System is…Some CARTO 3 Systems may get radio frequency interference through certain interconnected cable… | 02/09/2012Terminated |
| Z-3178-2011 | STOCKERT 70 Radio Frequency Generator, Catalog Number 57001 Indicated for use with a…Biosense Webster has initiated a voluntary field notification to all customers that have a Stockert 70 Radio… | 07/07/2011Terminated |
| Z-2667-2011 | LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers…The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes… | 05/23/2011Terminated |
| Z-2666-2011 | LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers…The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes… | 05/23/2011Terminated |
| Z-2665-2011 | HALO Catheter with Auto 10 Technology, Part Number D-1160-43-S, Catalog Number…The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes… | 05/23/2011Terminated |
| Z-2664-2011 | ISMUS CATH Mapping Catheter with Auto ID Technology, Part Number D-1171-34-S, Catalog #…The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes… | 05/23/2011Terminated |
| Z-3038-2011 | Duo-Decapolar Electrophysiology Catheter, Manufacturing Part Number D-1171-35-S, Catalog…The recall was expanded because between February and April 2011, Biosense Webster, Inc. notified customers… | 04/29/2011Terminated |
| Z-3037-2011 | ISMUS Catheter Mapping Catheter with Auto ID Technology, Manufacturing Part Number…The recall was expanded because between February and April 2011, Biosense Webster, Inc. notified customers… | 04/29/2011Terminated |
| Z-1839-2011 | 10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue, Manufacturing Part…The recall was initiated because Biosense Webster has confirmed that there is an inaccessibility of… | 02/15/2011Terminated |
| Z-0983-2012 | EZ Steer ThermoCool Nav Part Number D-1292-05-S Diagnostic/Ablation Catheter…Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution… | 11/22/2010Terminated |
| Z-0982-2012 | EZ Steer ThermoCool Nav Part Number D-1292-04-S Diagnostic/Ablation Catheter…Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution… | 11/22/2010Terminated |
| Z-0981-2012 | EZ Steer ThermoCool Nav Part Number D-1292-03-S Diagnostic/Ablation Catheter…Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution… | 11/22/2010Terminated |
| Z-0980-2012 | EZ Steer ThermoCool Nav Part Number D-1292-02-S Diagnostic/Ablation Catheter…Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution… | 11/22/2010Terminated |
| Z-0979-2012 | EZ Steer ThermoCool Nav Part Number D-1292-01-S Diagnostic/Ablation Catheter…Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution… | 11/22/2010Terminated |
| Z-0884-2011 | CARTO 3 System Interface Cable, 34-pin to 10-pin, Red, 10' - Part Number: D-1286-18…When connecting this cable to the mapping system, loss of Body Surface ECG signals may occur. This may… | 10/05/2010Terminated |
| Z-2369-2012 Class II | CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based…The recall was initiated because Biosense Webster has become aware of information regarding a potential… | 11/17/2009Terminated |
| Z-0369-2010 | Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 8mm DS Catheters; Part…Biosense Webster initiated the recall because of the potential concern with one of the Printed Circuit Board… | 10/02/2008Terminated |
| Z-0368-2010 | Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 4mm Catheters; Part…Biosense Webster initiated the recall because of the potential concern with one of the Printed Circuit Board… | 10/02/2008Terminated |
| Z-1704-2008 | Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping…This recall was initiated after the firm received several complaints reporting issues with deflection. The… | 03/25/2008Terminated |
| Z-1703-2008 | Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping…This recall was initiated after the firm received several complaints reporting issues with deflection. The… | 03/25/2008Terminated |
| Z-1647-2012 | EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional Catheter…The recall was initiated because the catheter unit was shipped with a label expiration date of 9/30/2010… | 12/15/2007Terminated |
| Z-0541-2007 | Biosense Webster PREFACE Guiding Sheath, Posterior, for the introduction of…Biosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or… | 11/17/2006Terminated |
| Z-0540-2007 | Biosense Webster PREFACE Guiding Sheath, Anterior, for the introduction of intravascular…Biosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or… | 11/17/2006Terminated |
| Z-0539-2007 | Biosense Webster PREFACE Guiding Sheath, Multipurpose 77cm, for the introduction of…Biosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or… | 11/17/2006Terminated |
| Z-0538-2007 | Biosense Webster PREFACE Guiding Sheath, Multipurpose 62cm, for the introduction of…Biosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or… | 11/17/2006Terminated |
| Z-0537-2007 | Biosense Webster PREFACE Guiding Sheath, Multipurpose Short, for the introduction of…Biosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or… | 11/17/2006Terminated |