BEUDAMED
    FDA Recall Terminated

    AB5000 Console Circulatory Support System Catalog Number: 0015-0000

    Recall: Z-0574-2007 · Initiated January 8, 2007

    Recall

    Recall Number
    Z-0574-2007
    Event Number
    37170
    Firm
    Abiomed, Inc.
    FEI Number
    1220648
    Product Code
    DSQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 8, 2007
    Posted
    March 7, 2007
    Terminated
    February 7, 2008
    Address
    22 Cherry Hill Dr, Danvers, MA, 01923-2575

    Description

    AB5000 Console Circulatory Support System Catalog Number: 0015-0000

    Reason

    Unit may alarm ''Low Flow'' and ''Low Pressure'' due to manufacturing material in the pressure source.

    Action

    Abiomed notified customers by letter dated 1/08/07. Service reps will inspect units and replace the defective components.

    Distribution

    Worldwide, including USA, Japan, Germany, Australia, and Mexico.

    Quantity

    55 units