BEUDAMED
    FDA Enforcement Class III Ongoing

    Battery Charging Station; Model: 0998-00-0802;

    Recall: Z-1587-2026 · Reported March 25, 2026

    Enforcement

    Recall Number
    Z-1587-2026
    Event ID
    98432
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Datascope Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 25, 2026
    Initiation Date
    February 6, 2026
    Classification Date
    March 19, 2026
    Address
    1300 Macarthur Blvd, N/A, Mahwah, NJ, 07430-2052, United States

    Description

    Battery Charging Station; Model: 0998-00-0802;

    Reason

    The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The right bay of the Battery Charging Station is not affected by this issue.

    Code Info

    Model: 0998-00-0802; UDI: 10607567111964; Serial Numbers: 200019347EAI, 200019847EAI, 200019447EAI, 210018625EAI, 210017925EAI, 210017525EAI, 210018425EAI, 210020144EAI, 210020944EAI, 210022544EAI, 210020244EAI, 210022144EAI, 210020044EAI, 210020544EAI, 210021344EAI, 210023244EAI, 210018025EAI, 210019025EAI, 210021144EAI, 210021044EAI, 210022344EAI, 210019225EAI, 210019125EAI, 210018525EAI, 210022844EAI, 200017647EAI, 210019725EAI, 210022744EAI;

    Distribution

    Worldwide - US Nationwide distribution in the states of FL, DC, GA, IL, IN, MD, MI, NC, TX, WA, WI and the countries of Australia, Hong Kong, Israel, Japan, Norway.

    Quantity

    28 units (20 US, 8 OUS)