BEUDAMED
    FDA Enforcement Class II Terminated

    Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.

    Recall: Z-1384-2018 · Reported April 25, 2018

    Enforcement

    Recall Number
    Z-1384-2018
    Event ID
    79646
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Datascope Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 25, 2018
    Initiation Date
    February 21, 2018
    Classification Date
    April 16, 2018
    Termination Date
    March 18, 2020
    Address
    15 Law Dr, Fairfield, NJ, 07004-3206, United States

    Description

    Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.

    Reason

    The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.

    Code Info

    0684 00 0294 01U and 0684 00 0294 02U

    Distribution

    US Nationwide Distribution

    Quantity

    655