BEUDAMED
    FDA Enforcement Class II Ongoing

    Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

    Recall: Z-2487-2023 · Reported September 6, 2023

    Enforcement

    Recall Number
    Z-2487-2023
    Event ID
    92489
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Datascope Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 6, 2023
    Initiation Date
    July 31, 2023
    Classification Date
    August 30, 2023
    Address
    1300 Macarthur Blvd, N/A, Mahwah, NJ, 07430-2052, United States

    Description

    Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

    Reason

    Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.

    Code Info

    All Lot Numbers. Model: 0998-00-0800-75, UDI: 10607567112312; Model: 0998-00-0800-83, UDI: 10607567108407; Model: 0998-00-0800-85, UDI: 10607567113449

    Distribution

    US Nationwide. Global Distribution.

    Quantity

    9379 units