The Recall Desk

Manufacturer

Biosense Webster, Inc.

31 recalls in our database name Biosense Webster, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
31
Critical
0
Severe
6
Most recent
2025-03-12

Of the 31 recalls from Biosense Webster, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (19%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 31

  • SevereFDA (Devices)·Z-1205-2025·2025-03-12

    FDA Recalls VARIPULSE Bi-Directional Ablation Catheter Due to Neurovascular Events

    Biosense Webster is recalling VARIPULSE Bi-Directional Ablation Catheters (REF D141201) due to an observed trend of neurovascular events. The FDA issued a Class I recall affecting approximately 497 units distributed worldwide.

    Product
    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 symptomat
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1290-2024·2024-03-20

    CARTO VIZIGO Guiding Sheath Recalled for Manufacturing Validation Issue

    Biosense Webster is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths after inadvertently mixing unvalidated devices into production. The recall affects 853 units distributed nationwide.

    Product
    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 cathe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1319-2023·2023-04-12

    Biosense Webster Guiding Sheath Recalled for Carton Label Mismatch

    Biosense Webster Carto Vizigo Bi-Directional Guiding Sheaths are being recalled because the carton label does not match the inner pouch label. No illnesses or injuries have been reported.

    Product
    Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1320-2023·2023-04-12

    Biosense Webster guiding sheath recalled for labeling mismatch

    Biosense Webster is recalling 316 units of Carto Vizigo guiding sheaths because the carton label does not match the inner sterile pouch label, potentially affecting product identification.

    Product
    Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1677-2022·2022-09-14

    CARTO VIZIGO Guiding Sheath Recalled Due to Water-Damaged Sterile Packaging

    Biosense Webster is recalling 98 units of CARTO VIZIGO 8.5F guiding sheaths due to water damage to packaging that may have compromised the sterile barrier, creating a potential infection risk.

    Product
    CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1286-2021·2021-03-31

    Biosense Webster Recalls CARTO VIZIGO Bi-Directional Guiding Sheaths

    Biosense Webster is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths because the hemostatic valve may dislodge, potentially causing minor bleeding or embolism.

    Product
    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 ab
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1285-2021·2021-03-31

    Biosense Webster Recalls CARTO VIZIGO Bi-Directional Guiding Sheaths

    Biosense Webster is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths because the hemostatic valve may dislodge, potentially causing minor bleeding or embolism.

    Product
    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 ab
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1287-2021·2021-03-31

    Biosense Webster Recalls CARTO VIZIGO Bi-Directional Guiding Sheath

    Biosense Webster is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths because the hemostatic valve may dislodge, potentially causing minor bleeding or embolism.

    Product
    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 a
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2878-2018·2018-09-05

    Biosense Webster Recalls WaveCrest Left Atrial Appendage Occlusion System Devices

    Biosense Webster is recalling 25 units of the WaveCrest Left Atrial Appendage Occlusion System (32 mm) because the delivery sheath may buckle during recapture.

    Product
    WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0210-2018·2017-12-13

    Biosense Webster Recalls SMARTABLATE RF System Generator Units

    Biosense Webster is recalling 185 SMARTABLATE RF System Generators because they may inadvertently deliver RF energy if the foot pedal is placed near Stereotaxis magnets.

    Product
    SMARTABLATE RF System Generator
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-0212-2018·2017-12-13

    Biosense Webster Recalls PENTARAY NAV Mapping Catheters Due to Labeling Update

    Biosense Webster is recalling 73,796 PENTARAY NAV High-Density Mapping Catheters to update contraindication language in the Instructions For Use regarding prosthetic valves.

    Product
    PENTARAY NAV High-Density Mapping Catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0211-2018·2017-12-13

    Biosense Webster Recalls PENTARAY NAV High-Density Mapping Catheters

    Biosense Webster is recalling PENTARAY NAV High-Density Mapping Catheters because the instructions for use were updated to indicate they should not be used in patients with prosthetic valves.

    Product
    PENTARAY NAV High-Density Mapping Catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0057-2018·2017-11-08

    Biosense Webster Recalls THERMOCOOL Catheters Due to Navigation System Alert

    Biosense Webster is recalling 19 THERMOCOOL catheters because they trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.

    Product
    THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0056-2018·2017-11-08

    Biosense Webster Recalls THERMOCOOL SMARTTOUCH Navigation Catheters

    Biosense Webster is recalling 64 THERMOCOOL SMARTTOUCH catheters because they may trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.

    Product
    THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0058-2018·2017-11-08

    Biosense Webster Recalls THERMOCOOL SF NAV Catheters Due to Display Error

    Biosense Webster is recalling THERMOCOOL SF NAV catheters because a system alert may cause physicians to ablate in unintended areas.

    Product
    THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0055-2018·2017-11-08

    Biosense Webster Recalls THERMOCOOL Catheters Due to Magnetic Distortion Alert

    Biosense Webster is recalling THERMOCOOL catheters because they may trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.

    Product
    THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0054-2018·2017-11-08

    Biosense Webster Recalls THERMOCOOL Catheters Due to System Alert Error

    Biosense Webster is recalling THERMOCOOL catheters because they may trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.

    Product
    THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2776-2016·2016-09-21

    Biosense Webster Recalls CARTO 3 EP Navigation Systems in China

    Biosense Webster is voluntarily re-installing 338 CARTO 3 EP Navigation Systems in China, Hong Kong, and Brazil that were moved without required testing.

    Product
    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 i
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1590-2016·2016-05-11

    Biosense Webster Recalls Pentaray Catheters for Labeling Clarification

    Biosense Webster is recalling Pentaray NAV High-Density Mapping Catheters to clarify contraindication language regarding patients with prosthetic valves.

    Product
    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.,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1591-2016·2016-05-11

    Biosense Webster Recalls Pentaray Catheters for Labeling Clarification

    Biosense Webster is recalling Pentaray Catheters to clarify contraindication language regarding patients with prosthetic valves in the product labeling.

    Product
    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,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0003-2016·2015-10-07

    Biosense Webster Recalls SOUNDSTAR eco Diagnostic Ultrasound Catheters

    Biosense Webster is recalling SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters because the ultrasound image may disappear if the CARTO 3 system restarts during a pericardial effusion.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0002-2016·2015-10-07

    Biosense Webster Recalls Carto 3 EP Navigation System Due to Image Loss

    Biosense Webster is recalling the Carto 3 EP Navigation System because the ultrasound image may disappear during use, requiring a system restart.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1691-2015·2015-06-03

    Biosense Webster Recalls SMARTABLATE RF Generator Systems Due to Unintended Energy Delivery

    Biosense Webster is recalling 115 SMARTABLATE RF Generator Systems because two complaints reported the device inadvertently delivered RF energy during procedures.

    Product
    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 compatible therapeutic catheters for use in conventional intracardiac RF ablation p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1525-2015·2015-05-06

    Biosense Webster HIS Catheter Recall Due to Navigation System Compatibility Issue

    Biosense Webster is recalling 503 Webster HIS Catheters because they are not recognized by the CARTO 3 navigation system.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1242-2015·2015-03-11

    Biosense Webster Recalls LASSO NAV Duo Loop eco Catheters

    Biosense Webster is recalling LASSO NAV Duo Loop eco Catheters due to reports of difficulty retracting and damage to the spine cover.

    Product
    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 mapping of the cardiac structures of the heart, i.e. recording or stimulation
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Biosense Webster (United States)

company in Diamond Bar, United States

Country
United States
Founded
1993

Official website

Source: Wikidata (Q30264019), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.