Biosense Webster, Inc. Recalls

All product recalls associated with Biosense Webster, Inc..

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Recall Summary

Total Recalls

19

Past Year

0

Class I (Serious)

0

Most Recent

Jan 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–19 of 19 recalls

VARIPULSE Ablation Catheter (Biosense) – Neurovascular Events (2025)

Due to an observed trend of neurovascular events

FDAJan 5, 2025AR, CA, CO +7 more• Biosense Webster, Inc.

Biosense Webster, Inc.: CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 ...

Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.

FDAFeb 16, 2024Nationwide• Biosense Webster, Inc.

Biosense Webster, Inc.: Biosense Webster Carto Vizigo Bi-Directional Guiding Shea...

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

FDAFeb 21, 2023Nationwide

• Biosense Webster, Inc.

Biosense Webster, Inc.: CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D13...

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 sterile barrier could be a source for infection.

FDAJun 29, 2022Nationwide• Biosense Webster, Inc.

Biosense Webster, Inc.: Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sh...

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

FDAFeb 26, 2021Nationwide• Biosense Webster, Inc.

Biosense Webster (israel), Ltd.: CARTO 3 System (Software Version V7.1.80), CARTO VISITAG ...

Software defect may result in disapperance of tag sites during recalculation and lead to additional ablation sites. This may lead to prolongation of the procedure and, in extremely rare circumstances, cardiac perforation.

FDAJun 22, 2020Nationwide• Biosense Webster (israel), Ltd.

BIOSENSE WEBSTER: PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTROD...

Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.

FDAApr 22, 2020Nationwide• BIOSENSE WEBSTER

BIOSENSE WEBSTER: PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA...

Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.

FDAApr 22, 2020Nationwide• BIOSENSE WEBSTER

Biosense Webster, Inc.: ThermoCool SmartTouch Navigation Catheters, Catalog No. D...

The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter.

Class IIModerate

FDAOct 19, 2014Nationwide• Biosense Webster, Inc.

Biosense Webster, Inc.: CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is i...

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 other electrophysiology (EP) equipment, including the CARTO 3 Electropysiology Mapping System.

FDANov 17, 2009Nationwide• Biosense Webster, Inc.

Biosense Webster, Inc.: CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is...

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 other electrophysiology (EP) equipment, including the CARTO 3 Electropysiology Mapping System.

Class IIModerate

FDANov 17, 2009Nationwide• Biosense Webster, Inc.

BioSense Webster, Inc. Circuito Interior Norte, # 1820 Parque Industrial Salvarcar Cd. Juarez, Chihuahua Mexico: Biosense Webster NaviStar RMT Diagnostic/Ablation Steerab...

Biosense Webster initiated the recall because of the potential concern with one of the Printed Circuit Board (PCB) components used in the NaviStar RMT Catheters, which may cause the ablation catheter icon to shift on the map viewer when RF energy is being applied. Therefore the user, attempting a linear ablation in the location displayed on the CARTO RMT screen, may ultimately apply RF energy to u

FDAOct 2, 2008CA, CT, FL +24 more• BioSense Webster, Inc. Circuito Interior Norte, # 1820 Parque Industrial Salvarcar Cd. Juarez, Chihuahua Mexico

Biosense Webster Inc: Circular Mapping Catheter-Biosense Webster LASSO 2515 Var...

This recall was initiated after the firm received several complaints reporting issues with deflection. The catheter may become caught in the mitral valve, requiring surgical procedures, valve may be torn while trying to dislodge, unable to retract the catheter through the sheath and require surgical intervention to remove, pulling on catheter to remove may lead to large atrial septal tear, and sep

FDAMar 25, 2008Nationwide• Biosense Webster Inc

Biosense Webster, Inc.: EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Dir...

The recall was initiated because the catheter unit was shipped with a label expiration date of 9/30/2010, which is 11 months beyond the correct expiration date of 10/31/2009.

FDADec 15, 2007Nationwide• Biosense Webster, Inc.

Biosense Webster, Inc.: Biosense Webster PREFACE Guiding Sheath, Multipurpose Sho...

Biosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or partially detaching from the PREFACE Sheath during use in the left atrium.

FDANov 17, 2006Nationwide• Biosense Webster, Inc.

Biosense Webster, Inc.: Thermocool Irrigated Catheters Celsius LABEL US Part Num...

Increased complaints regarding catheters with leaks and flow obstruction.

FDAAug 8, 2005FL, IL, MA +3 more• Biosense Webster, Inc.

Biosense Webster, Inc.: Deflectable Tip Catheter for cardiac mapping. Mfg Part #...

Potential that product is incorrectly assembled with monel wire attached to the tip dome rather than copper wire.

FDAAug 16, 2004Nationwide• Biosense Webster, Inc.

Biosense Webster, Inc.: Stockert 70 Radio Frequency Ablation Generator

Generator Failure resulting increase of catheter temperature that could not be controlled by power reduction.

FDAJul 16, 2004Nationwide• Biosense Webster, Inc.

Biosense Webster, Inc.: Quickcable Autoclaveable Cable Electrode Cable

Mislabeling.

FDAMay 21, 2004Nationwide• Biosense Webster, Inc.

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