BEUDAMED
    FDA Recall Terminated

    Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number: M00576550 The stent system is a permanently implanted expandable metal stent designed for palliation of tracheobronchial (TB) strictures. The system consists of a flexible delivery catheter preloaded with an expandable metal stent. The stent is offered in a variety of sizes of different diameters and lengths

    Recall: Z-1567-2016 · Initiated March 18, 2016

    Recall

    Recall Number
    Z-1567-2016
    Event Number
    73660
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    JCT
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 18, 2016
    Terminated
    August 26, 2016
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234

    Description

    Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number: M00576550 The stent system is a permanently implanted expandable metal stent designed for palliation of tracheobronchial (TB) strictures. The system consists of a flexible delivery catheter preloaded with an expandable metal stent. The stent is offered in a variety of sizes of different diameters and lengths

    Reason

    Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm

    Action

    Boston Scientific issued notification letters dated March 17, 2016. The notification instructs the customer to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form. Customers with questions should call 866-868-4004. For questions regarding this recall call 508-382-9555.

    Distribution

    Nationwide Distribution to AL, CA, MA, and TX.

    Quantity

    4 units