Company:Biosense Webster, Inc.
Date of Enforcement Report 11/8/2017
Class lI:
PRODUCT
THERMOCOOL SF NAV Catheters Model Numbers – BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
Recall Number Z-0058-2018
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 distortion” when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy..
RECALLING FIRM/MANUFACTURER
Biosense Webster, Inc., Irwindale CA. on 9/16/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
329 units
DISTRIBUTION
Nationwide and Internationally
___________________________________