Biosense Webster, Inc.: 14 recalls on record

Recalls filed with 1 agency: FDA (14).

First recall on record: September 19, 2012. Most recent: March 20, 2024.

Risk classification: Class I: 1 · Class II: 13

Most recent recalls

DateAgencyProduct
March 20, 2024FDACARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directi…Z-1290-2024
March 31, 2021FDABiosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138…Z-1286-2021
September 5, 2018FDAWaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 …Z-2878-2018
December 13, 2017FDAPENTARAY NAV High-Density Mapping Catheter.Z-0211-2018
December 13, 2017FDASMARTABLATE RF System GeneratorZ-0210-2018
November 8, 2017FDATHERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-0…Z-0054-2018
November 8, 2017FDATHERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-SZ-0058-2018
October 7, 2015FDASOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-lu…Z-0003-2016
November 5, 2014FDAThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D13270…Z-0139-2015
March 19, 2014FDAPENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D12…Z-1176-2014
February 26, 2014FDACartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-…Z-1045-2014
July 10, 2013FDA20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electroph…Z-1617-2013
April 3, 2013FDA20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is inten…Z-1023-2013
September 19, 2012FDACARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atr…Z-2369-2012

Questions about this company

How many recalls does Biosense Webster, Inc. have?
Recalert has 14 U.S. recalls on record for Biosense Webster, Inc., published between September 19, 2012 and March 20, 2024.
What was the most recent Biosense Webster, Inc. recall?
FDA recall Z-1290-2024, published March 20, 2024: 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 steer…
Which agencies have handled Biosense Webster, Inc. recalls?
Biosense Webster, Inc. appears as the recalling firm in recalls from: FDA (14).

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