BEUDAMED
    FDA Enforcement Class II Ongoing

    Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178

    Recall: Z-1279-2023 · Reported March 29, 2023

    Enforcement

    Recall Number
    Z-1279-2023
    Event ID
    91652
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Datascope Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 29, 2023
    Initiation Date
    February 28, 2023
    Classification Date
    March 22, 2023
    Address
    1300 Macarthur Blvd, N/A, Mahwah, NJ, 07430-2052, United States

    Description

    Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178

    Reason

    There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction in the degree of augmentation provided to the patient during therapy.

    Code Info

    Serial Numbers: MH353075E2 MH353057E2 MH353067E2 MH353077E2 MH356112G2 MH353056E2 MH356111G2 MH356119G2 MH353065E2 MH356117G2

    Distribution

    Distribution list not yet provided.

    Quantity

    10