BEUDAMED
    FDA Enforcement Class II Ongoing

    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65

    Recall: Z-0075-2022 · Reported October 13, 2021

    Enforcement

    Recall Number
    Z-0075-2022
    Event ID
    88651
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Datascope Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 13, 2021
    Initiation Date
    September 8, 2021
    Classification Date
    October 7, 2021
    Address
    1300 Macarthur Blvd, Mahwah, NJ, 07430-2052, United States

    Description

    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65

    Reason

    The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.

    Code Info

    All lots

    Distribution

    Worldwide distribution - US Nationwide distribution.

    Quantity

    5054 total (US), 5033 total (OUS)