BEUDAMED
    FDA Recall Terminated

    CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx An electromechanical system used to inflate and deflate intra-aortic balloons.

    Recall: Z-1062-2015 · Initiated December 16, 2014

    Recall

    Recall Number
    Z-1062-2015
    Event Number
    69863
    Firm
    Maquet Datascope Corp Cardiac Assist Division
    FEI Number
    3001418283
    Product Code
    DSP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 16, 2014
    Posted
    February 7, 2015
    Terminated
    June 9, 2017
    Address
    1300 MacArthur Blvd., Mahwah, NJ, 07430-2052

    Description

    CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx An electromechanical system used to inflate and deflate intra-aortic balloons.

    Reason

    Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration units. If fiber-optic connector is inserted into the Maquet CS300 or CARDIOSAVE IABP, cap will prevent connection of unit and may become dislodged and remain in IABPs fiber-optic receptacle.

    Action

    Maquet Inc. sent a Product Recall Medical Device Field Correction letter/Field Correction response form, dated 12/16/2014 via Fed Ex. The letter identified the affected product and the reason for the recall. Users were asked to inspect their inventory for the affected units. If customers have any affected product, they are to follow the instructions provided. Additionally, users are to complete and return the attached Field Correction Response Form to acknowledge receipt of the letter and to indicate completion of the steps outlined. Completed forms should be returned by e-mailing a scanned copy to [email protected] or faxing a copy to 1-973-396-3607. Technical questions should be directed to the Technical Support Department at 1-800-777-4222.

    Distribution

    Worldwide Distribution

    Quantity

    838 units-US; 364 units - OUS