BEUDAMED
    FDA Recall Terminated

    Datascope CS 100 Intra-Aortic Balloon Pump and Datascope CS 300 Intra-Aortic Balloon Pump, Datascope Corp. Mahwah, NJ 07430

    Recall: Z-0567-2008 · Initiated November 19, 2007

    Recall

    Recall Number
    Z-0567-2008
    Event Number
    45957
    Firm
    Datascope Corp
    FEI Number
    2221819
    Product Code
    DSP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 19, 2007
    Posted
    January 31, 2008
    Terminated
    May 20, 2008
    Address
    800 MacArthur Blvd, Mahwah, NJ, 07430-2001

    Description

    Datascope CS 100 Intra-Aortic Balloon Pump and Datascope CS 300 Intra-Aortic Balloon Pump, Datascope Corp. Mahwah, NJ 07430

    Reason

    Defective Circuit Board -- A defect in the Printed Circuit Board's (PCB) in the CS 100 and CS300 Intra-Aortic Balloon Pump may cause the pump to exhibit intermittent malfunctions, which include failure to start-up or reset of the display screen during therapy.

    Action

    Datascope sent a Product Field Correction notification letters to Hospital Administrators, via certified mail, on November 19, 2007. The letter informed them of a defect in the circuit board. It described the possible malfunction and provided instructions should malfunctioning occur. Datascope will be replacing the defective circuit boards in all affected IABP units. A Service Representative will be contacting the hospital to arrange for the replacement of the defective board.

    Distribution

    Worldwide Distribution

    Quantity

    70 units US