BEUDAMED
    FDA Recall Terminated

    Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)

    Recall: Z-1140-2015 · Initiated January 30, 2015

    Recall

    Recall Number
    Z-1140-2015
    Event Number
    70510
    Firm
    Maquet Datascope Corp Cardiac Assist Division
    FEI Number
    3001418283
    Product Code
    DSP
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    January 30, 2015
    Posted
    February 23, 2015
    Terminated
    September 29, 2017
    Address
    1300 MacArthur Blvd., Mahwah, NJ, 07430-2052

    Description

    Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)

    Reason

    Power supply malfunction complaints related to suboptimal thermal management.

    Action

    Maquet Inc. sent a recall letter/return response form dated 1/30/2015.

    Distribution

    US Nationwide distribution

    Quantity

    1,300 units