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Browse Device Recalls

31 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 31 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 31 FDA device recalls.

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DateProductReasonClassFirm
Jan 5, 2025 VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Cathe... Due to an observed trend of neurovascular events Class I Biosense Webster, Inc.
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 inadvertently mixed into... Class II Biosense Webster, Inc.
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 code on the carton lab... Class II Biosense Webster, Inc.
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 code on the carton lab... Class II Biosense Webster, Inc.
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 catheters into the heart,... Class II Biosense Webster, Inc.
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 the dilator or device... Class II Biosense Webster, Inc.
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 the dilator or device... Class II Biosense Webster, Inc.
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 the dilator or device... Class II Biosense Webster, Inc.
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 may fold or buckle,... Class I Biosense Webster, Inc.
Sep 6, 2017 THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-13270... Biosense Webster, Inc. has recently received an increased number of complaints related to the dis... Class II Biosense Webster, Inc.
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 complaints related to the dis... Class II Biosense Webster, Inc.
Sep 6, 2017 THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S) Biosense Webster, Inc. has recently received an increased number of complaints related to the dis... Class II Biosense Webster, Inc.
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 complaints related to the dis... Class II Biosense Webster, Inc.
Sep 6, 2017 THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S,... Biosense Webster, Inc. has recently received an increased number of complaints related to the dis... Class II Biosense Webster, Inc.
Jun 14, 2017 SMARTABLATE RF System Generator Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and ... Class II Biosense Webster, Inc.
May 17, 2017 PENTARAY NAV High-Density Mapping Catheter. Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Cat... Class II Biosense Webster, Inc.
May 17, 2017 PENTARAY NAV High-Density Mapping Catheter. Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Cat... Class II Biosense Webster, Inc.
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 identified CARTO 3 Syst... Class II Biosense Webster, Inc.
Apr 14, 2016 Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208,... Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in ... Class II Biosense Webster, Inc.
Apr 14, 2016 Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D12... Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in ... Class II Biosense Webster, Inc.
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 Navigation System needed... Class II Biosense Webster, Inc.
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 Navigation System needed... Class II Biosense Webster, Inc.
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 recognized by the CARTO 3 ... Class II Biosense Webster, Inc.
Mar 19, 2015 SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and ... Biosense Webster is recalling the SMARTABLATE Generator System because Biosense Webster has recei... Class II Biosense Webster, Inc.
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 reports of difficul... Class II Biosense Webster, Inc.
Oct 19, 2014 ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D13... The recall was initiated because Biosense Webster is providing additional labeling for the safe a... Class II Biosense Webster, Inc.
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 potential to have part... Class II Biosense Webster, Inc.
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 Carto 3 System (V3.2... Class II Biosense Webster, Inc.
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 has been incorrectly ... Class II Biosense Webster, Inc.
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 calibrated. When a cathet... Class II Biosense Webster, Inc.
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 information regarding a pot... Class II Biosense Webster, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.