Company · US
Biosense Webster, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2026. Name variants (Inc, Corp, punctuation) are merged.
76510(k) clearances (2 in 12 months)
62recalls (0 in 12 months)
39recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DQK | Computer, Diagnostic, Programmable | 41 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 34 |
| DYB | Introducer, Catheter | 15 |
| MTD | Catheter, Intracardiac Mapping, High-Density Array | 14 |
| LPB | Cardiac Ablation Percutaneous Catheter | 11 |
| OBJ | Catheter, Ultrasound, Intravascular | 10 |
| OAE | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | 6 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 2 |
| PGW | Ear, Nose, And Throat Stereotaxic Instrument | 2 |
| MDT | Elisa, Trichinella Spiralis | 1 |
| NGV | System, Appendage Closure, Left Atrial | 1 |
| QZI | Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 20, 2026 | K252972 | CARTO 3 EP Navigation System V8.4 Biosense Webster, Inc. | DQK |
| Jan 18, 2026 | K254085 | CARTO 3 EP Navigation System V9.0 with PIU Plus Biosense Webster, Inc. | DQK |
| Aug 22, 2025 | K252302 | CARTO 3 EP Navigation System V8.1 Biosense Webster, Inc. | DQK |
| Jun 28, 2024 | K241540 | NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Catheter Biosense Webster, Inc. | OBJ |
| Jun 12, 2024 | K240050 | SOUNDSTAR CRYSTAL Ultrasound Catheter Biosense Webster, Inc. | OBJ |
| Sep 7, 2023 | K231207 | CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) Biosense Webster, Inc. | DQK |
| Jul 10, 2023 | K231412 | CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S) Biosense Webster, Inc. | DYB |
| Jul 10, 2023 | K231312 | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® Biosense Webster, Inc. | MTD |
| Mar 2, 2023 | K230253 | OPTRELL Mapping Catheter with TRUEref Technology Biosense Webster, Inc. | MTD |
| Feb 16, 2023 | K223766 | NUVISION NAV Ultrasound Catheter Biosense Webster, Inc. | OBJ |
| Feb 16, 2023 | K223733 | CARTO® 3 EP Navigation System with CARTOSOUND 4D Version 7.4 Biosense Webster, Inc. | DQK |
| Aug 17, 2022 | K221112 | CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) Biosense Webster, Inc. | DQK |
| Mar 18, 2022 | K211438 | OPTRELL Mapping Catheter with TRUEref Technology Biosense Webster, Inc. | MTD |
| Jan 26, 2022 | K211219 | LASSOSTAR NAV Circular Mapping Catheter Biosense Webster, Inc. | DRF |
| Oct 29, 2021 | K213264 | CARTO 3 EP Navigation System Version 7.2 Biosense Webster, Inc. | DQK |
| Nov 25, 2020 | K200484 | CARTO® 3 EP Navigation System with Signal Processing Unit Biosense Webster, Inc. | DQK |
| Aug 6, 2020 | K201750 | Pentaray Nav eco High-Density Mapping Catheter Biosense Webster, Inc. | MTD |
| Jul 31, 2020 | K193237 | Carto Octaray Mapping Catheter with Trueref Technology Biosense Webster, Inc. | MTD |
| Jun 30, 2020 | K193632 | LassoStar Circular Mapping Catheter Biosense Webster, Inc. | DRF |
| Jan 30, 2020 | K192397 | TruDi Navigation System Biosense Webster | PGW |
| Jul 20, 2019 | K191660 | CARTO 3 EP Navigation System, Version 7.1 and Accessories Biosense Webster, Inc. | DQK |
| Aug 24, 2018 | K173978 | CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module Biosense Webster, Inc. | DQK |
| Jun 14, 2018 | K173977 | CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module Biosense Webster, Inc. | DQK |
| Jun 1, 2018 | K180238 | CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT Biosense Webster, Inc. | DQK |
| Jul 25, 2017 | K170997 | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath Biosense Webster, Inc. | DYB |
| Jul 25, 2017 | K170600 | CARTO 3 EP Navigation System, Version 6.0 and Accessories Biosense Webster, Inc. | DQK |
| Oct 24, 2016 | K161701 | CARTO ENT System Biosense Webster | PGW |
| Jul 1, 2014 | K133916 | CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2 Biosense Webster, Inc. | DQK |
| Mar 12, 2014 | K140318 | SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER Biosense Webster | OBJ |
| Jan 24, 2014 | K132782 | CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2 Biosense Webster, Inc. | DQK |
| Aug 14, 2013 | K130602 | LASSO NAV DUO LOOP CATHETER Biosense Webster, Inc. | DRF |
| Mar 5, 2013 | K123837 | PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER Biosense Webster, Inc. | MTD |
| May 24, 2012 | K120425 | PENTARAY NAV HIGH-DENSITY MAPPING CATHETER Biosense Webster, Inc. | MTD |
| May 7, 2012 | K120550 | CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD) Biosense Webster, Inc. | DQK |
| Dec 5, 2011 | K113213 | LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2 Biosense Webster, Inc. | DRF |
| Nov 18, 2011 | K112050 | SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER Biosense Webster, Inc. | OBJ |
| Oct 5, 2011 | K112007 | CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2 Biosense Webster, Inc. | DQK |
| May 2, 2011 | K101991 | WEBSTER DUO-DECAPOLAR CATHETER Biosense Webster, Inc. | DRF |
| Jan 21, 2011 | K103746 | CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD) Biosense Webster, Inc. | DQK |
| Jun 22, 2010 | K101345 | WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04, Biosense Webster, Inc. | DRF |
| Jun 22, 2010 | K101138 | SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12 Biosense Webster, Inc. | OBJ |
| Jun 18, 2010 | K093566 | CARTO XP EP NAVIGATION SYSTEM, VERSION 10 Biosense Webster, Inc. | DQK |
| Jun 18, 2010 | K093376 | LASSO NAV CATHETER Biosense Webster, Inc. | DRF |
| Dec 4, 2009 | K093455 | CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES Biosense Webster, Inc. | DQK |
| Dec 4, 2009 | K091352 | SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05 Biosense Webster, Inc. | OBJ |
| Oct 13, 2009 | K090017 | CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES Biosense Webster, Inc. | DQK |
| Oct 1, 2009 | K091789 | CARTO RMT EP NAVIGATION SYSTEM V8 Biosense Webster, Inc. | DQK |
| Sep 4, 2009 | K090898 | CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER Biosense Webster, Inc. | DRF |
| Aug 7, 2009 | K092064 | SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12 Biosense Webster, Inc. | OBJ |
| Mar 24, 2009 | K090120 | REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106 Biosense Webster, Inc. | DRF |
Newest 50 of 76.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 28, 2025 | Biosense Webster, Inc. 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 fo Completed |
QZI | None listed |
| Mar 13, 2024 | Biosense Webster, Inc. 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 steerabl Open, Classified |
DYB | K170997 |
| Apr 1, 2023 | Biosense Webster, Inc. Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile Open, Classified |
DYB | K170997 |
| Apr 1, 2023 | Biosense Webster, Inc. Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile Open, Classified |
DYB | K170997 |
| Jun 29, 2022 | Biosense Webster, Inc. CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart. Open, Classified |
DYB | K170997 |
| Feb 26, 2021 | 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)10846835016277 - Product Usage: provide accessibility and maneuver Completed |
DYB | K170997 |
| Feb 26, 2021 | 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)10846835016260 - Product Usage: provide accessibility and maneuvera Completed |
DYB | K170997 |
| Feb 26, 2021 | 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)10846835016253 - Product Usage: provide accessibility and maneuvera Completed |
DYB | K170997 |
| Apr 22, 2020 | BIOSENSE WEBSTER 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 electr Terminated |
MDT | K123837 |
| Apr 22, 2020 | BIOSENSE WEBSTER 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 Terminated |
MTD | K120425 |
| May 7, 2018 | Biosense Webster, Inc. WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523. Terminated |
NGV | None listed |
| Sep 6, 2017 | Biosense Webster, Inc. THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S Terminated |
LPB | None listed |
| Sep 6, 2017 | Biosense Webster, Inc. THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S) Terminated |
LPB | None listed |
| Sep 6, 2017 | Biosense Webster, Inc. THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S) Terminated |
LPB | None listed |
| Sep 6, 2017 | Biosense Webster, Inc. THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S Terminated |
LPB | None listed |
| Sep 6, 2017 | Biosense Webster, Inc. THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S Terminated |
LPB | None listed |
| Jun 14, 2017 | Biosense Webster, Inc. SMARTABLATE RF System Generator Terminated |
LPB | None listed |
| May 17, 2017 | Biosense Webster, Inc. PENTARAY NAV High-Density Mapping Catheter. Terminated |
MTD | K120425 K123837 |
| May 17, 2017 | Biosense Webster, Inc. PENTARAY NAV High-Density Mapping Catheter. Terminated |
MTD | K120425 K123837 |
| Sep 9, 2016 | 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 CARTO 3 EP Navigation System is intended to be used in catheter-ba Terminated |
DQK | K112007 K132782 +1 |
| Apr 14, 2016 | Biosense Webster, Inc. 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 multip Terminated |
MTD | K123837 |
| Apr 14, 2016 | Biosense Webster, Inc. 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 e Terminated |
MTD | K120425 |
| Oct 1, 2015 | Biosense Webster, Inc. 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 device Terminated |
OBJ | K140318 |
| Oct 1, 2015 | Biosense Webster, Inc. 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. Terminated |
DQK | K133916 |
| May 28, 2015 | Biosense Webster, Inc. SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107.
Product Usage:
The use of the SMART ABLATE Generator and all accessories is indicated in combination with compat Terminated |
OAE | None listed |
| Apr 27, 2015 | Biosense Webster, Inc. 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 Terminated |
DRF | None listed |
| Mar 3, 2015 | 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 Catheter is indicated for multiple electrode electrophysiological Terminated |
DRF | K130602 |
| Oct 27, 2014 | Biosense Webster, Inc. ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603. Terminated |
LPB | None listed |
| Mar 11, 2014 | Biosense Webster, Inc. PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205, D128207, D128208, D128210, D128211.
The Biosense Webster PENTARAY NAV High-De Terminated |
MTD | K120425 K123837 |
| Feb 20, 2014 | 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 CAPTURES (IMAGES AND CINE CLIPS) CAN BE IMPORTED TO AND DISPLAYED Terminated |
DQK | K120550 |
| Jun 28, 2013 | Biosense Webster, Inc. 20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S.
Designed to facilitate electrophysiological mapping of the atria of the heart. Terminated |
DRF | K113213 |
| Mar 28, 2013 | 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 LASSO NAV Eco Catheter and CARTO 3 System. Terminated |
DQK | K120550 |
| Sep 12, 2012 | 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 allows real-time display of cardiac maps in a number of different Terminated |
DQK | K090017 |
| May 22, 2012 | Biosense Webster, Inc. EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional Catheter
Cardiovascular catheter for use in electrophysiological diagnosis and ablation. Terminated |
DRF | K090898 K101345 |
| Mar 20, 2012 | Biosense Webster, Inc. CARTO 3 Systems, Product Code M-4800-01
The intended use of the CARTO 3 System is catheter-based cardiac electrophysiological (EP) procedures. Terminated |
DQK | K090017 K093455 +2 |
| Feb 7, 2012 | Biosense Webster, Inc. EZ Steer ThermoCool Nav Part Number D-1292-05-S Diagnostic/Ablation Catheter instructions for use.
The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-ele Terminated |
OAE | None listed |
| Feb 7, 2012 | Biosense Webster, Inc. EZ Steer ThermoCool Nav Part Number D-1292-04-S Diagnostic/Ablation Catheter instructions for use.
The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-ele Terminated |
OAE | None listed |
| Feb 7, 2012 | Biosense Webster, Inc. EZ Steer ThermoCool Nav Part Number D-1292-03-S Diagnostic/Ablation Catheter instructions for use.
The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-ele Terminated |
OAE | None listed |
| Feb 7, 2012 | Biosense Webster, Inc. EZ Steer ThermoCool Nav Part Number D-1292-02-S Diagnostic/Ablation Catheter instructions for use.
The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-ele Terminated |
OAE | None listed |
| Feb 7, 2012 | Biosense Webster, Inc. EZ Steer ThermoCool Nav Part Number D-1292-01-S Diagnostic/Ablation Catheter instructions for use.
The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-ele Terminated |
OAE | None listed |
| Sep 12, 2011 | Biosense Webster, Inc. STOCKERT 70 Radio Frequency Generator, Catalog Number 57001
Indicated for use with a Biosense Webster, Inc. diagnostic/ablation deflectable tip catheter to deliver radio frequency energy during card Terminated |
LPB | None listed |
| Aug 18, 2011 | Biosense Webster, Inc. Duo-Decapolar Electrophysiology Catheter, Manufacturing Part Number D-1171-35-S, Catalog Number D728260RT
Duo-Decapolar Electrophysiology Catheter has been designed for electrophysiological mapping o Terminated |
DRF | K953768 |
| Aug 18, 2011 | Biosense Webster, Inc. ISMUS Catheter Mapping Catheter with Auto ID Technology, Manufacturing Part Number D-1171-34-S, Catalog Number D7R20P14CT
The ISMUS Catheter with Auto ID Technology has been designed for electrophysi Terminated |
DRF | K953768 |
| Jun 27, 2011 | Biosense Webster, Inc. LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers D-1220-82-S, Catalog Numbers 07L2015CT
The affected catheters are indicated for multiple electrode electrophysiologic Terminated |
DRF | K002333 |
| Jun 27, 2011 | Biosense Webster, Inc. LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers D-122081-
S, Catalog Numbers D7L2020CT
The affected catheters are indicated for multiple electrode electrophysiologic Terminated |
DRF | K002333 |
| Jun 27, 2011 | Biosense Webster, Inc. HALO Catheter with Auto 10 Technology, Part Number D-1160-43-S, Catalog Number
D7T20282CT
The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structure Terminated |
DRF | K953768 |
| Jun 27, 2011 | Biosense Webster, Inc. ISMUS CATH Mapping Catheter with Auto ID Technology, Part Number D-1171-34-S, Catalog #
D7R20P14CT
The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac Terminated |
DRF | K953768 |
| Mar 28, 2011 | Biosense Webster, Inc. 10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue, Manufacturing Part Number 01287-09, Catalog Number D128709.
This cable is used to connect an Auto 10 10-pole catheter to an EP reco Terminated |
DQK | K090017 |
| Jan 7, 2011 | Biosense Webster, Inc. CARTO 3 System Interface Cable, 34-pin to 10-pin, Red, 10' - Part Number: D-1286-18; Catalog Number CR3410CT
This product provides a signal interface between a Biosense Webster electrophysiology cathe Terminated |
DSA | K090017 |
| Nov 19, 2009 | BioSense Webster, Inc. Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 8mm DS Catheters; Part Numbers: D-1259-01 & D-1259-02 Terminated |
LPB | None listed |
Newest 50 of 62.