BEUDAMED
    FDA Recall Terminated

    Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, STD PS port, Implantable Port System, Model # M001453660, Catalog #45-366

    Recall: Z-0734-04 · Initiated February 10, 2004

    Recall

    Recall Number
    Z-0734-04
    Event Number
    28398
    Firm
    Boston Scientific Corporation
    FEI Number
    3001451463
    Product Code
    LJT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 10, 2004
    Posted
    July 20, 2004
    Terminated
    October 25, 2005
    Address
    1 Boston Scientific Pl, Natick, MA, 01760-1536

    Description

    Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, STD PS port, Implantable Port System, Model # M001453660, Catalog #45-366

    Reason

    Reports of catheter separation/fracture after implantation resulting in distal migration of the catheter.

    Action

    Letters dated 2/9/04 with instructions to return current inventory . Also included is information concerning implanted ports.

    Distribution

    Shipments were nationwide to 158 medical facilities nationwide.

    Quantity

    308 units