BEUDAMED
    FDA Recall Open, Classified

    Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190

    Recall: Z-0758-2021 · Initiated November 16, 2020

    Recall

    Recall Number
    Z-0758-2021
    Event Number
    86880
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    FAD
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    November 16, 2020
    Address
    300 Boston Scientific Way, Marlborough, MA, 01752-1291

    Description

    Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190

    Reason

    Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.

    Action

    On November 16, 2020, the firm distributed Urgent Medical Device Removal letters to affected customers. Customers were informed of the product issue and asked to take the following actions: - Verify whether you have any product from the affected lots/batches within your inventory - Immediately cease use or distribution of any remaining unused product from the affected lots/batches - Segregate affected material and return it to BSC in accordance with removal instructions included in the letter. - Distributors should forward the notification to their customers Your local Sales Representative can answer any questions that you may have regarding this notification.

    Distribution

    Distribution US nationwide and Japan.

    Quantity

    458 units