BEUDAMED
    FDA Enforcement Class II Terminated

    Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)

    Recall: Z-1140-2015 · Reported March 4, 2015

    Enforcement

    Recall Number
    Z-1140-2015
    Event ID
    70510
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Maquet Datascope Corp - Cardiac Assist Division
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 4, 2015
    Initiation Date
    January 30, 2015
    Classification Date
    February 23, 2015
    Termination Date
    September 29, 2017
    Address
    1300 MacArthur Blvd., N/A, Mahwah, NJ, 07430-2052, United States

    Description

    Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)

    Reason

    Power supply malfunction complaints related to suboptimal thermal management.

    Code Info

    0998-00-0800-31 0998-UC-0800-31 0998-00-0800-32 0998-UC-0800-33 0998-00-0800-33 0998-UC-0800-52 0998-00-0800-34 0998-UC-0800-53 0998-00-0800-35 0998-UC-0800-55 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55. CARDIOSAVE Hybrid IABPs serviced with a new/replacement power supply after August 19, 2014 are not affected.

    Distribution

    US Nationwide distribution

    Quantity

    1,300 units