BEUDAMED
    FDA Enforcement Class I Terminated

    Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.

    Recall: Z-1523-2014 · Reported May 28, 2014

    Enforcement

    Recall Number
    Z-1523-2014
    Event ID
    67815
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Maquet Datascope Corp - Cardiac Assist Division
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 28, 2014
    Initiation Date
    March 21, 2014
    Classification Date
    May 21, 2014
    Termination Date
    March 20, 2018
    Address
    1300 MacArthur Blvd., N/A, Mahwah, NJ, 07430-2052, United States

    Description

    Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.

    Reason

    Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning.

    Code Info

    IABP Model Numbers System 98 0998-00-0446-xx 0998-UC-0446-xx System 98XT 0998-00-0479-xx 0998-UC-0479-xx CS100i 0998-UC-0446Hxx 0998-UC-0479Hxx CS100 0998-00-3013-xx 0998-UC-3013-xx CS300 0998-00-3023-xx 0998-UC-3023-xx

    Distribution

    Worldwide Distribution - USA (nationwide) and approximately 104 countries.

    Quantity

    11,881 units (US 5183 and OUS 6698)