Company:Biosense Webster, Inc.
Date of Enforcement Report 11/8/2017
Class lI:
PRODUCT
THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S
Recall Number Z-0054-2018
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
357 units
DISTRIBUTION
Nationwide and Internationally
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