Biosense Webster recalls
Biosense Webster appears in 33 official U.S. recall notices indexed by RecallRadar, most recently on 2025-03-12.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 33 |
|---|---|
| Published | 2012-09-19 to 2025-03-12 |
| By agency | FDA Device (33) |
| By classification | Class II (31), Class I (2) |
| By status | terminated (25), completed (4), ongoing (4) |
| Distribution named in notices | AR, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MI, MN, MO, NJ, NM, NY, OH, PA, TN, TX, US, UT, WA, WI |
Recalls
- VARIPULSE Bi-Directional Ablation Catheter REF D141201
FDA Device · Class I · 2025-03-12 · Biosense Webster
Reason: Due to an observed trend of neurovascular events - CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibili…
FDA Device · Class II · 2024-03-20 · Biosense Webster
Reason: Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process. - Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
FDA Device · Class II · 2023-04-12 · Biosense Webster
Reason: Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch - Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
FDA Device · Class II · 2023-04-12 · Biosense Webster
Reason: Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch - CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501
FDA Device · Class II · 2022-09-14 · Biosense Webster
Reason: Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile barrier of the product inside. Devices with a compromised ste… - Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)108468…
FDA Device · Class II · 2021-03-31 · Biosense Webster
Reason: There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism - Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE EO, udi: (01)108468…
FDA Device · Class II · 2021-03-31 · Biosense Webster
Reason: There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism - Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)10846…
FDA Device · Class II · 2021-03-31 · Biosense Webster
Reason: There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism - PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Densi…
FDA Device · Class II · 2020-06-24 · Biosense Webster
Reason: Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map. - PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-D…
FDA Device · Class II · 2020-06-24 · Biosense Webster
Reason: Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map. - WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523
FDA Device · Class I · 2018-09-05 · Biosense Webster
Reason: When attempting to recapture the 32-mm device, the tip of the delivery sheath may fold or buckle, resulting in increased retraction force and difficulty or failure to recapture the device. - PENTARAY NAV High-Density Mapping Catheter
FDA Device · Class II · 2017-12-13 · Biosense Webster
Reason: Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves. - SMARTABLATE RF System Generator
FDA Device · Class II · 2017-12-13 · Biosense Webster
Reason: Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets. - PENTARAY NAV High-Density Mapping Catheter
FDA Device · Class II · 2017-12-13 · Biosense Webster
Reason: Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves. - THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
FDA Device · Class II · 2017-11-08 · Biosense Webster
Reason: Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic… - THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S
FDA Device · Class II · 2017-11-08 · Biosense Webster
Reason: Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic… - THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)
FDA Device · Class II · 2017-11-08 · Biosense Webster
Reason: Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic… - THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)
FDA Device · Class II · 2017-11-08 · Biosense Webster
Reason: Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic… - THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S
FDA Device · Class II · 2017-11-08 · Biosense Webster
Reason: Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic… - 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…
FDA Device · Class II · 2016-09-21 · Biosense Webster
Reason: Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Systems that were moved and installed in China without testing and approval by Biosense Webster Technical Services, as describ… - Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 The Biosense Webster Pentaray…
FDA Device · Class II · 2016-05-11 · Biosense Webster
Reason: Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to patients with prosthetic valves. - Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 The Biosense Webster Penta…
FDA Device · Class II · 2016-05-11 · Biosense Webster
Reason: Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to patients with prosthetic valves. - Carto 3 EP Navigation System
FDA Device · Class II · 2015-10-07 · Biosense Webster
Reason: Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navig… - SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters
FDA Device · Class II · 2015-10-07 · Biosense Webster
Reason: Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navig… - SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107
FDA Device · Class II · 2015-06-03 · Biosense Webster
Reason: Biosense Webster is recalling the SMARTABLATE Generator System because Biosense Webster has received two complaints reporting that during an RMT procedure the SMARTABLATE RF Generator inadvertently delivered RF energy. - WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure
FDA Device · Class II · 2015-05-06 · Biosense Webster
Reason: The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System. - 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
FDA Device · Class II · 2015-03-11 · Biosense Webster
Reason: Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover. - ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603
FDA Device · Class II · 2014-11-05 · Biosense Webster
Reason: The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter. - PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205, D128207, D128208,…
FDA Device · Class II · 2014-03-19 · Biosense Webster
Reason: Biosense Webster is recalling the PentaRay Nav Catheter because it has the potential to have partial tip separation from the catheter shaft. Biosense Webster is expanding the recall on 5/1/14 to include all lots of the… - CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3
FDA Device · Class II · 2014-02-26 · Biosense Webster
Reason: Biosense Webster has initiated a recall of the CartoUnivu Module within the Carto 3 System (V3.2.2 and V3.2.3) when used with Siemens Axiom Artis VB Fluoroscopy systems in particular procedural configurations only. If t… - 20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart
FDA Device · Class II · 2013-07-10 · Biosense Webster
Reason: Biosense Webster is recalling the 20-Pole LASSO NAV Catheter Eco because it has been incorrectly calibrated causing them to be recognized and displayed as a 10-Pole LASSO NAV Catheter Eco by the CARTO 3 System. - 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…
FDA Device · Class II · 2013-04-03 · Biosense Webster
Reason: Biosense is recalling the 20-Pole Eco Cable because it was incorrectly calibrated. When a catheter is connected to an affected to an affected 20-Pole Eco Cable, the catheter will not be recognized by the impacted 54 cab… - CARTO 3 V1.05(FG-5400-00)
FDA Device · Class II · 2012-09-19 · Biosense Webster
Reason: The recall was initiated because Biosense Webster has become aware of information regarding a potential hazard that may occur during the operation of a Bloom EP Stimulator device in conjunction with RF generators and ot…