BEUDAMED
    FDA Recall Terminated

    CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product Usage: The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons

    Recall: Z-1386-2017 · Initiated December 23, 2016

    Recall

    Recall Number
    Z-1386-2017
    Event Number
    76052
    Firm
    Maquet Datascope Corp Cardiac Assist Division
    FEI Number
    3001418283
    Product Code
    DSP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 23, 2016
    Terminated
    March 1, 2019
    Address
    1300 Macarthur Blvd, Mahwah, NJ, 07430-2052

    Description

    CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product Usage: The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons

    Reason

    Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped.

    Action

    Maquet contacted their customers via letter on 12/23/16 and additional customers identified were notified on 1/10/17 and issued a recall letter/return response form. The letter identified the affected product problem and actions to be taken. Customers were instructed to complete and return the response form via fax to 1-973-629-1518 or email to [email protected]

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    8000