Recall – Cardiac EP software defect inadvertently leads to additional ablation sites

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

Upcoming Training

Agile Methods for Medical Device and Health IT Software

One day course sponsored by the Irish Medtech Association / Ibec, Connected Health Skillnet.  November 19, 2020, 9 am to 6 pm IST.  Read more and registration information:  Agile methods Flyer (19 Nov)

Registration Link:  https://connectedhealthskillnet.ie/IBEC/Events.nsf/

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