Company: Biosense Webster (Israel), Ltd.
Date of Enforcement Report: 9/2/2020
Class II
PRODUCT
CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module – Product Usage: FGThe intended use of the system is catheter-based cardiac electrophysiological (EP) procedures. The system provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure, Product Number: -5400-00, UDI: 10846835000870
Recall Number: Z-2880-2020
REASON
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.
RECALLING FIRM/MANUFACTURER
Biosense Webster (Israel), Ltd. on 6/22/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
All serial numbers
DISTRIBUTION
U.S. Nationwide and International