BEUDAMED
    FDA Recall Terminated

    Guidant Acrobat Vacuum Stabilizer, Model Number OM-9000.

    Recall: Z-0611-2007 · Initiated December 1, 2006

    Recall

    Recall Number
    Z-0611-2007
    Event Number
    37272
    Firm
    Guidant Cardiac Surgery
    FEI Number
    3000719698
    Product Code
    MWS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 1, 2006
    Posted
    March 16, 2007
    Terminated
    December 4, 2007
    Address
    3200 Lakeside Dr, Santa Clara, CA, 95054-2807

    Description

    Guidant Acrobat Vacuum Stabilizer, Model Number OM-9000.

    Reason

    Vacuum Tubing Failure- vacuum tubing fails before the labeled two year shelf life. This may result in partial or complete vacuum loss during surgery.

    Action

    The firm has issued by FedEx letters dated 12/1/2006, to all consignees who received the product in the US, and has also informed their foreign distributors in the same manner on December 4, 2006. The firm''s field representatives were notified via teleconference on December 1, 2006. A hard copy of the notice was delivered to field reps on December 4 as well.

    Distribution

    Product was distributed to a total of 529 consignees, 482 domestic and 47 international. Product was sent Nationwide, Europe and Asia.

    Quantity

    57,691 units distributed total