BEUDAMED
    FDA Enforcement Class II Ongoing

    Optima Coil System Model OPTI0520CSF10. For endovascular embolization.

    Recall: Z-1680-2022 · Reported September 14, 2022

    Enforcement

    Recall Number
    Z-1680-2022
    Event ID
    90724
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    BALT USA, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 14, 2022
    Initiation Date
    July 26, 2022
    Classification Date
    September 6, 2022
    Address
    29 Parker Ste 100, N/A, Irvine, CA, 92618-1667, United States

    Description

    Optima Coil System Model OPTI0520CSF10. For endovascular embolization.

    Reason

    Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.

    Code Info

    Model Number: OPTI0520CSF10 UDI-DI Code: 00818053026164 Lot Number: F220600470

    Distribution

    U.S.: AZ and FL O.U.S.: None

    Quantity

    4 devices