Biosense Webster, Inc.

Complete recall history across all FDA and CPSC categories — 31 total recalls

Biosense Webster, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (31)

FDA medical device enforcement actions by Biosense Webster, Inc.

Date Product Reason Class
Jan 5, 2025 VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Cathe... Due to an observed trend of neurovascular events Class I
Feb 16, 2024 CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOT... Due to a manufacturing issue, device under process validation phase were inad... Class II
Feb 21, 2023 Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), RE... Incorrect labeling; specifically, the product name, lot number and product co... Class II
Feb 21, 2023 Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF... Incorrect labeling; specifically, the product name, lot number and product co... Class II
Jun 29, 2022 CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to intro... Outside packaging for a device indicated for introducing cardiovascular cathe... Class II
Feb 26, 2021 Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) ... There is a potential for the hemostatic valve to dislodge while introducing t... Class II
Feb 26, 2021 Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C... There is a potential for the hemostatic valve to dislodge while introducing t... Class II
Feb 26, 2021 Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C... There is a potential for the hemostatic valve to dislodge while introducing t... Class II
May 7, 2018 WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numb... When attempting to recapture the 32-mm device, the tip of the delivery sheath... Class I
Sep 6, 2017 THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-13270... Biosense Webster, Inc. has recently received an increased number of complaint... Class II
Sep 6, 2017 THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-... Biosense Webster, Inc. has recently received an increased number of complaint... Class II
Sep 6, 2017 THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S) Biosense Webster, Inc. has recently received an increased number of complaint... Class II
Sep 6, 2017 THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02... Biosense Webster, Inc. has recently received an increased number of complaint... Class II
Sep 6, 2017 THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S,... Biosense Webster, Inc. has recently received an increased number of complaint... Class II
Jun 14, 2017 SMARTABLATE RF System Generator Generator may inadvertently deliver RF energy if the foot pedal is placed in ... Class II
May 17, 2017 PENTARAY NAV High-Density Mapping Catheter. Contraindication language updated in the Instructions For Use (IFU) to indica... Class II
May 17, 2017 PENTARAY NAV High-Density Mapping Catheter. Contraindication language updated in the Instructions For Use (IFU) to indica... Class II
Aug 15, 2016 CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG5... Biosense Webster, Inc. is initiating a voluntary correction to re-install ide... Class II
Apr 14, 2016 Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208,... Biosense Webster is recalling the Pentaray Catheters to clarify the contraind... Class II
Apr 14, 2016 Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D12... Biosense Webster is recalling the Pentaray Catheters to clarify the contraind... Class II
Sep 10, 2015 Carto 3 EP Navigation System. Electro physiology system which views of the el... Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navi... Class II
Sep 10, 2015 SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac ... Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navi... Class II
Apr 17, 2015 WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping... The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recogn... Class II
Mar 19, 2015 SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and ... Biosense Webster is recalling the SMARTABLATE Generator System because Biosen... Class II
Feb 25, 2015 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... Class II
Oct 19, 2014 ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D13... The recall was initiated because Biosense Webster is providing additional lab... Class II
Feb 20, 2014 PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Cat... Biosense Webster is recalling the PentaRay Nav Catheter because it has the po... Class II
Feb 12, 2014 CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog ... Biosense Webster has initiated a recall of the CartoUnivu Module within the ... Class II
Jun 19, 2013 20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilita... Biosense Webster is recalling the 20-Pole LASSO NAV Catheter Eco because it h... Class II
Mar 5, 2013 20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Ca... Biosense is recalling the 20-Pole Eco Cable because it was incorrectly calibr... Class II
Nov 17, 2009 CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for cathet... The recall was initiated because Biosense Webster has become aware of informa... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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