BEUDAMED
    FDA Recall Open, Classified

    VICI RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.

    Recall: Z-1592-2021 · Initiated April 12, 2021

    Recall

    Recall Number
    Z-1592-2021
    Event Number
    87721
    Firm
    Boston Scientific Corporation
    FEI Number
    3002095335
    Product Code
    QAN
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 12, 2021
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    VICI RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.

    Reason

    The firm has received reports of stent migration after implantation

    Action

    Boston Scientific initiated the recall by letter on April 12, 2021. The letter requested the consignee cease use and further distribution of the affected product, segregate and return to Boston Scientific. Distributors were directed to further distribute the notice to their customers. For questions contact your local Sales Representative.

    Distribution

    Worldwide - US Nationwide Distribution

    Quantity

    34,248 units