BEUDAMED
    FDA Recall Terminated

    AMPLATZER PFO Occluder. Order No. 9-PFO-025. Device is not PMA approved in the US. 25mm Sterile EO. The AMPLATZER PFO Occluder is a self-expandable, double disc device made from a Nitinol wire mesh. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA.

    Recall: Z-0053-2007 · Initiated June 1, 2006

    Recall

    Recall Number
    Z-0053-2007
    Event Number
    35814
    Firm
    AGA Medical Corporation
    FEI Number
    3005334138
    Product Code
    MLV
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 1, 2006
    Posted
    October 20, 2006
    Terminated
    April 1, 2007
    Address
    682 Mendelssohn Ave N, Golden Valley, MN, 55427-4306

    Description

    AMPLATZER PFO Occluder. Order No. 9-PFO-025. Device is not PMA approved in the US. 25mm Sterile EO. The AMPLATZER PFO Occluder is a self-expandable, double disc device made from a Nitinol wire mesh. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA.

    Reason

    AMPLATZER PFO Occluders were mislabeled with incorrect device sizes. The lot M06B01-58 contains 18mm PFO Occluders but is labeled as containing 25mm devices. Lot M06B01-52 contains 25mm PFO Occluders but is labeled as containing 18mm devices. The affected product was not distributed within the United States and does not affect U.S. consignees.

    Action

    Consignees were notified of the recall via fax and mail. Consignees were instructed to cease distribution and use of the devices. Returned devices will be replaced.

    Distribution

    Foreign Distribution ONLY-Product was distributed in Italy, Switzerland, Germany and the Slovak Republic.

    Quantity

    18