BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1587-2026 · Initiated February 6, 2026

    Recall

    Recall Number
    Z-1587-2026
    Event Number
    98432
    Firm
    Datascope Corp.
    FEI Number
    3001418283
    Product Code
    DSP
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 6, 2026
    Posted
    March 19, 2026
    Address
    1300 Macarthur Blvd, Mahwah, NJ, 07430-2052

    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.

    Action

    On February 6, 2026 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken by the customer: Our records indicate that you may have one or more Battery Charging Station(s) in your facility. Please forward this information to all current Battery Charging Station users within your facility. " If you are currently using one of the affected Battery Charging Stations, please follow the instructions in the Battery Charging Instructions section of this letter. " Complete and sign the attached Response Form to acknowledge that you have received and understand this notification. Return the completed form to [email protected]. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action.

    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)