BEUDAMED
    FDA Enforcement Class II Ongoing

    Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570

    Recall: Z-0757-2021 · Reported January 6, 2021

    Enforcement

    Recall Number
    Z-0757-2021
    Event ID
    86880
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 6, 2021
    Initiation Date
    November 16, 2020
    Classification Date
    December 30, 2020
    Address
    300 Boston Scientific Way, N/A, Marlborough, MA, 01752-1291, United States

    Description

    Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570

    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.

    Code Info

    GTIN 08714729058410: Lots 25578577, 25598812, 25609220, 25614542, 25614545, 25619687, 25641771, 25713852, 25753933, 25790349. GTIN 08714729067986: Lots 25640715, 25670518, 25686790, 25686791, 25686792, 25741763, 25741770, 25753937, 25790351, 25795704, 25802759, 25809481, 25822104. GTIN 08714729068020: Lots 25578740, 25583824.

    Distribution

    Distribution US nationwide and Japan.

    Quantity

    458 units