BEUDAMED
    FDA Recall Terminated

    NexStent Monorail Carotid Stent System, Material number M 001553000, Catalog number 55-300, packaged in a PET tray manufactured by Boston Scientific Corp, Natick, MA.

    Recall: Z-2089-2008 · Initiated May 15, 2006

    Recall

    Recall Number
    Z-2089-2008
    Event Number
    48430
    Firm
    Boston Scientific Cupertino, Corporation
    FEI Number
    3005231525
    Product Code
    NIM
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 15, 2006
    Posted
    September 16, 2008
    Terminated
    September 25, 2008
    Address
    10231 Bubb Rd, Cupertino, CA, 95014-4167

    Description

    NexStent Monorail Carotid Stent System, Material number M 001553000, Catalog number 55-300, packaged in a PET tray manufactured by Boston Scientific Corp, Natick, MA.

    Reason

    Tip may detach from stent delivery system.

    Action

    The firm issued notification letters and information sheets to consignees describing the risks. The firm requested the products be returned to the firm. If you have questions, contact the firm at 408-517-2800.

    Distribution

    188 consignees throughout Europe received the product.

    Quantity

    1326 units