BEUDAMED
    FDA Enforcement Class I Terminated

    CS 100 Intra-Aortic Balloon Pump

    Recall: Z-2737-2017 · Reported August 2, 2017

    Enforcement

    Recall Number
    Z-2737-2017
    Event ID
    77566
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Maquet Datascope Corp - Cardiac Assist Division
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Press Release
    Report Date
    August 2, 2017
    Initiation Date
    June 16, 2017
    Classification Date
    July 27, 2017
    Termination Date
    November 29, 2019
    Address
    1300 Macarthur Blvd, N/A, Mahwah, NJ, 07430-2052, United States

    Description

    CS 100 Intra-Aortic Balloon Pump

    Reason

    The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.

    Code Info

    0998-XX-3013-XX, 0998-UC-3013-XX

    Distribution

    Worldwide Distribution - (in over 100 countries) US (Nationwide)

    Quantity

    12,319 units total