Biosense Webster, Inc.
Biosense Webster, Inc. holds FDA 510(k) medical device clearances, first cleared 1999, most recent 2026, with 31 FDA device recalls on record.
Top product codes for Biosense Webster, Inc.
FDA recalls by Biosense Webster, Inc.
10 most recent of 31- 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.
- 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.
- Z-1319-2023 — Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
- Z-1320-2023 — Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
- Z-1677-2022 — CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
- 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.
- 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.
- 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.
- Z-2878-2018 — WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
- Z-0056-2018 — THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Biosense Webster, Inc.
- K252972 — CARTO 3 EP Navigation System V8.4
- K254085 — CARTO 3 EP Navigation System V9.0 with PIU Plus
- K252302 — CARTO 3 EP Navigation System V8.1
- K241540 — NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Catheter
- K240050 — SOUNDSTAR CRYSTAL Ultrasound Catheter
- K231207 — CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
- 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
- K231412 — CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)
- K230253 — OPTRELL Mapping Catheter with TRUEref Technology
- K223733 — CARTO® 3 EP Navigation System with CARTOSOUND 4D Version 7.4
- K223766 — NUVISION NAV Ultrasound Catheter
- K221112 — CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)
- K211438 — OPTRELL Mapping Catheter with TRUEref Technology
- K211219 — LASSOSTAR NAV Circular Mapping Catheter
- K213264 — CARTO 3 EP Navigation System Version 7.2
- K200484 — CARTO® 3 EP Navigation System with Signal Processing Unit
- K201750 — Pentaray Nav eco High-Density Mapping Catheter
- K193237 — Carto Octaray Mapping Catheter with Trueref Technology
- K193632 — LassoStar Circular Mapping Catheter
- K191660 — CARTO 3 EP Navigation System, Version 7.1 and Accessories
- K173978 — CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module
- K173977 — CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module
- K180238 — CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT
- K170600 — CARTO 3 EP Navigation System, Version 6.0 and Accessories
- K170997 — CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath
- K133916 — CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2
- K132782 — CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2
- K130602 — LASSO NAV DUO LOOP CATHETER
- K123837 — PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
- K120425 — PENTARAY NAV HIGH-DENSITY MAPPING CATHETER
- K120550 — CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)
- K113213 — LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2
- K112050 — SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER
- K112007 — CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2
- K101991 — WEBSTER DUO-DECAPOLAR CATHETER
- K103746 — CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD)
- K101138 — SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12
- K101345 — WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,
- K093376 — LASSO NAV CATHETER
- K093566 — CARTO XP EP NAVIGATION SYSTEM, VERSION 10
- K091352 — SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05
- K093455 — CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES
- K090017 — CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES
- K091789 — CARTO RMT EP NAVIGATION SYSTEM V8
- K090898 — CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER
- K092064 — SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12
- K090120 — REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106
- K081258 — VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02
- K080425 — CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02
- K072202 — CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01)
- K070242 — SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05
- K070240 — CARTO XP EP NAVIGATION SYSTEM, VERSION 9
- K061463 — ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S
- K061468 — REFSTAR EXTERNAL REFERENCE PATCH
- K060047 — CARTO RMT EP NAVIGATION SYSTEM V8
- K053194 — NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE
- K042681 — CARTO RMT EP NAVIGATION SYSTEM
- K042998 — REFSTAR RMT EXTERNAL REFERENCE PATCH
- K052083 — NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER
- K050877 — CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR
- K050217 — FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING)
- K042999 — CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8
- K031161 — VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER
- K020863 — CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM
- K013083 — CARTO XP EP NAVIGATION SYSTEM
- K002333 — BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220
- K001390 — BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES
- K001139 — PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M
- K000190 — MODIFICATION TO CARTO EP NAVIGATION SYSTEM
- K000248 — CARTO EP NAVIGATION SYSTEM
- K000332 — NOGA CARDIAC NAVIGATION SYSTEM
- K993729 — MODIFICATION TO CARTO EP NAVIGATION SYSTEM
- K992968 — CARTO EP NAVIGATION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.