Biosense Webster Inc
Irvine, CA, US
BIOSENSE WEBSTER, INC. appears in FDA device records in Irvine, CA. FDA records list 76 510(k) clearances between and , 557 PMA records and 3 registered establishments. As of , FDA records show 62 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 76FDA records hold 76 510(k) clearances for Biosense Webster Inc between 1999 and 2026. The busiest year on record is 2009, with 8. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 2 |
| 2000 | 6 |
| 2001 | 1 |
| 2003 | 2 |
| 2005 | 6 |
| 2006 | 4 |
| 2007 | 3 |
| 2008 | 1 |
| 2009 | 8 |
| 2010 | 4 |
| 2011 | 5 |
| 2012 | 2 |
| 2013 | 2 |
| 2014 | 3 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 3 |
| 2019 | 1 |
| 2020 | 5 |
| 2021 | 1 |
| 2022 | 3 |
| 2023 | 6 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252972 | CARTO™ 3 EP Navigation System V8.4 | DQK | Substantially Equivalent | |
| K254085 | CARTO™ 3 EP Navigation System V9.0 with PIU Plus | DQK | Substantially Equivalent | |
| K252302 | CARTO™ 3 EP Navigation System V8.1 | DQK | Substantially Equivalent | |
| K241540 | NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter | OBJ | Substantially Equivalent | |
| K240050 | SOUNDSTAR™ CRYSTAL Ultrasound Catheter | OBJ | Substantially Equivalent | |
| K231207 | CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) | DQK | Substantially Equivalent | |
| K231412 | CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S) | DYB | Substantially Equivalent | |
| K231312 | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID | MTD | Substantially Equivalent | |
| K230253 | OPTRELL™ Mapping Catheter with TRUEref™ Technology | MTD | Substantially Equivalent | |
| K223766 | NUVISION™ NAV Ultrasound Catheter | OBJ | Substantially Equivalent | |
| K223733 | CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4 | DQK | Substantially Equivalent | |
| K221112 | CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) | DQK | Substantially Equivalent | |
| K211438 | OPTRELL Mapping Catheter with TRUEref Technology | MTD | Substantially Equivalent | |
| K211219 | LASSOSTAR NAV Circular Mapping Catheter | DRF | Substantially Equivalent | |
| K213264 | CARTO 3 EP Navigation System Version 7.2 | DQK | Substantially Equivalent | |
| K200484 | CARTO® 3 EP Navigation System with Signal Processing Unit | DQK | Substantially Equivalent | |
| K201750 | Pentaray Nav eco High-Density Mapping Catheter | MTD | Substantially Equivalent | |
| K193237 | Carto Octaray Mapping Catheter with Trueref Technology | MTD | Substantially Equivalent | |
| K193632 | LassoStar Circular Mapping Catheter | DRF | Substantially Equivalent | |
| K192397 | TruDi Navigation System | PGW | Substantially Equivalent | |
| K191660 | CARTO 3 EP Navigation System, Version 7.1 and Accessories | DQK | Substantially Equivalent | |
| K173978 | CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module | DQK | Substantially Equivalent | |
| K173977 | CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module | DQK | Substantially Equivalent | |
| K180238 | CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT | DQK | Substantially Equivalent | |
| K170997 | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath | DYB | Substantially Equivalent | |
| K170600 | CARTO 3 EP Navigation System, Version 6.0 and Accessories | DQK | Substantially Equivalent | |
| K161701 | CARTO ENT System | PGW | Substantially Equivalent | |
| K133916 | CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2 | DQK | Substantially Equivalent | |
| K140318 | SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER | OBJ | Substantially Equivalent | |
| K132782 | CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2 | DQK | Substantially Equivalent | |
| K130602 | LASSO NAV DUO LOOP CATHETER | DRF | Substantially Equivalent | |
| K123837 | PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER | MTD | Substantially Equivalent | |
| K120425 | PENTARAY NAV HIGH-DENSITY MAPPING CATHETER | MTD | Substantially Equivalent | |
| K120550 | CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD) | DQK | Substantially Equivalent | |
| K113213 | LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2 | DRF | Substantially Equivalent | |
| K112050 | SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER | OBJ | Substantially Equivalent | |
| K112007 | CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2 | DQK | Substantially Equivalent | |
| K101991 | WEBSTER DUO-DECAPOLAR CATHETER | DRF | Substantially Equivalent | |
| K103746 | CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD) | DQK | Substantially Equivalent | |
| K101345 | WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04, | DRF | Substantially Equivalent | |
| K101138 | SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12 | OBJ | Substantially Equivalent | |
| K093566 | CARTO XP EP NAVIGATION SYSTEM, VERSION 10 | DQK | Substantially Equivalent | |
| K093376 | LASSO NAV CATHETER | DRF | Substantially Equivalent | |
| K093455 | CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES | DQK | Substantially Equivalent | |
| K091352 | SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05 | OBJ | Substantially Equivalent | |
| K090017 | CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES | DQK | Substantially Equivalent | |
| K091789 | CARTO RMT EP NAVIGATION SYSTEM V8 | DQK | Substantially Equivalent | |
| K090898 | CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER | DRF | Substantially Equivalent | |
| K092064 | SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12 | OBJ | Substantially Equivalent | |
| K090120 | REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106 | DRF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013300026 | 3013300026 | BIOSENSE WEBSTER, INC. | 31 Technology Drive, Suite 200, Irvine, CA 92618 US | 2026 | and 1 more, listed in full below |
| 3022451073 | 3022451073 | BIOSENSE WEBSTER, INC. | 23 Hubble Drive, Irvine, CA 92618 US | 2026 | |
| 9673241 | 3003248396 | BIOSENSE WEBSTER, INC. | CIRCUITO INTERIOR NORTE, No. 1820, JUAREZ Chihuahua 32574 MX | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- LPBCardiac Ablation Percutaneous Catheter
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording
- DYGCatheter, Flow Directed
- MTDCatheter, Intracardiac Mapping, High-Density Array
- OAECatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- OADCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- OBJCatheter, Ultrasound, Intravascular
- DQKComputer, Diagnostic, Programmable
- PGWEar, Nose, And Throat Stereotaxic Instrument
- LDFElectrode, Pacemaker, Temporary
- DYBIntroducer, Catheter
- QZIPercutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
Recall records
Showing 25 of 62| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1205-2025 | VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used for TRUPULSE Generator, for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. The catheter provides location information when used with the CARTO 3 System. | Due to an observed trend of neurovascular events | Class I | Open, Classified | |
| Z-1290-2024 | CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with a three-way stopcock is provided for air or blood aspiration, and fluid infusion. The handle is equipped with a rotating collar to deflect the tip clockwise = 180 and counterclockwise = 180. The steerable sheath features distal vent holes to facilitate aspiration and minimize cavitation, and a radiopaque tip marker to allow fluoroscopic visualization. The sheath has electrodes on the outer surface to allow the sheath to interface with compatible CARTO" 3 Systems. | Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process. | Class II | Open, Classified | |
| Z-1320-2023 | Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile | Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch | Class II | Open, Classified | |
| Z-1319-2023 | Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile | Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch | Class II | Open, Classified | |
| Z-1677-2022 | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart. | Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile barrier of the product inside. Devices with a compromised sterile barrier could be a source for infection. | Class II | Open, Classified | |
| Z-1287-2021 | Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)10846835016277 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures. | There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism | Class II | Completed | |
| Z-1286-2021 | Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016260 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures. | There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism | Class II | Completed | |
| Z-1285-2021 | Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016253 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures. | There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism | Class II | Completed | |
| Z-2372-2020 | PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. | Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map. | Class II | Terminated | |
| Z-2371-2020 | PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. | Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map. | Class II | Terminated | |
| Z-2878-2018 | WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523. | When attempting to recapture the 32-mm device, the tip of the delivery sheath may fold or buckle, resulting in increased retraction force and difficulty or failure to recapture the device. | Class I | Terminated | |
| Z-0058-2018 | THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S | Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy. | Class II | Terminated | |
| Z-0057-2018 | THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S) | Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy. | Class II | Terminated | |
| Z-0056-2018 | 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 Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy. | Class II | Terminated | |
| Z-0055-2018 | THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S | Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy. | Class II | Terminated | |
| Z-0054-2018 | THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S | Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy. | Class II | Terminated | |
| Z-0210-2018 | SMARTABLATE RF System Generator | Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets. | Class II | Terminated | |
| Z-0212-2018 | PENTARAY NAV High-Density Mapping Catheter. | Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves. | Class II | Terminated | |
| Z-0211-2018 | PENTARAY NAV High-Density Mapping Catheter. | Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves. | Class II | Terminated | |
| Z-2776-2016 | 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 3 EP Navigation System is intended to be used in catheter-based cardiac electrophysiological (EP) procedures. The CARTO 3 System provides information about the electrical activity of the heart and catheter location during the procedure. | Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Systems that were moved and installed in China without testing and approval by Biosense Webster Technical Services, as described in the Instructions for Use (IFU). | Class II | Terminated | |
| Z-1591-2016 | Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, ie., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Pentaray NAV High-Density Mapping Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems. | Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to patients with prosthetic valves. | Class II | Terminated | |
| Z-1590-2016 | Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, ie., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Pentaray NAV High-Density Mapping Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems. | Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to patients with prosthetic valves. | Class II | Terminated | |
| Z-0003-2016 | SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. | Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navigation System when used with the SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. New precautions added. | Class II | Terminated | |
| Z-0002-2016 | Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps. | Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navigation System when used with the SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. New precautions added. | Class II | Terminated | |
| Z-1525-2015 | WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation and recording only. Catalog No: 01085413 | The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain