BEUDAMED
    FDA Recall Terminated

    Abiomed : Abiocor Implantable Heart Replacement Kit System Catalog Number:: 0034-8401-HD The product is intended to be implanted in the thoracic cavity and replaces operation and function of the native heart.

    Recall: Z-2304-2008 · Initiated June 13, 2008

    Recall

    Recall Number
    Z-2304-2008
    Event Number
    48724
    Firm
    Abiomed, Inc.
    FEI Number
    1220648
    Product Code
    LOZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 13, 2008
    Posted
    September 20, 2008
    Terminated
    October 8, 2008
    Address
    22 Cherry Hill Dr, Danvers, MA, 01923-2575

    Description

    Abiomed : Abiocor Implantable Heart Replacement Kit System Catalog Number:: 0034-8401-HD The product is intended to be implanted in the thoracic cavity and replaces operation and function of the native heart.

    Reason

    Subassembly incorrectly aligned

    Action

    Abiomed notified consignee by letter and on site visit on 5/13/08. The unit was removed and replaced.

    Distribution

    NJ

    Quantity

    1 unit