Home / Brands / Biosense Webster
Biosense Webster Recalls
33 recalls on record · September 19, 2012 to March 12, 2025 · Medical Devices
Recalls by year
12
13
14
15
16
17
18
20
21
22
23
24
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 10, 2013Medical DevicesFDA
Biosense Webster, Inc. recalls 20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atri
Hazard: 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.
April 3, 2013Medical DevicesFDA
Biosense Webster, Inc. recalls 20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface
Hazard: 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 cable serial numbers within the field.
September 19, 2012Medical DevicesFDA
Biosense Webster, Inc. recalls CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. Th
Hazard: 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.