BEUDAMED
    FDA Enforcement Class II Terminated

    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: Z-2880-2020 · Reported September 2, 2020

    Enforcement

    Recall Number
    Z-2880-2020
    Event ID
    85910
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biosense Webster (israel), Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 2, 2020
    Initiation Date
    June 22, 2020
    Classification Date
    August 24, 2020
    Termination Date
    January 6, 2022
    Address
    4, Hatnufah Street, N/A, Yoqne'Am Illit, N/A, N/A, Israel

    Description

    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

    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.

    Code Info

    All serial numbers

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AL, AK, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, and WI *Three (3) U.S. government consignees. The countries of Australia, Austria, Belgium, Chile, China, Colombia, Czechia, Denmark, Finland, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Latvia, Netherlands, Norway, Poland, Portugal, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom.

    Quantity

    N/A