BEUDAMED
    FDA Enforcement Class II Ongoing

    iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616

    Recall: Z-0024-2025 · Reported October 16, 2024

    Enforcement

    Recall Number
    Z-0024-2025
    Event ID
    95329
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Atrium Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 16, 2024
    Initiation Date
    September 9, 2024
    Classification Date
    October 7, 2024
    Address
    40 Continental Blvd, Merrimack, NH, 03054-4332, United States

    Description

    iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616

    Reason

    There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.

    Code Info

    UDI-DI: 00650862426168; Lot Number: 508083; Serial Numbers: 508083031, 508083032, 508083034, 508083035, 508083036, 508083037, 508083038, 508083039, 508083040, 508083041, 508083042

    Distribution

    US Nationwide distribution in the states of FL, MA, MI, OH, WA.

    Quantity

    11 devices