BEUDAMED
    FDA Enforcement Class III Ongoing

    Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX

    Recall: Z-1907-2023 · Reported June 21, 2023

    Enforcement

    Recall Number
    Z-1907-2023
    Event ID
    92214
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Datascope Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 21, 2023
    Initiation Date
    May 4, 2023
    Classification Date
    June 14, 2023
    Address
    1300 Macarthur Blvd, N/A, Mahwah, NJ, 07430-2052, United States

    Description

    Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX

    Reason

    The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.

    Code Info

    UDI-DI: 10607567108414; Serial Numbers: CB286971I8 CB283804G8 CB283867G8 CB283522G8

    Distribution

    International distribution in the country of Germany.

    Quantity

    4 units