BEUDAMED
    FDA Enforcement Class II Ongoing

    AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;

    Recall: Z-1261-2022 · Reported June 22, 2022

    Enforcement

    Recall Number
    Z-1261-2022
    Event ID
    90178
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Micro Therapeutics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 22, 2022
    Initiation Date
    April 27, 2022
    Classification Date
    June 13, 2022
    Address
    9775 Toledo Way, Irvine, CA, 92618-1811, United States

    Description

    AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;

    Reason

    Due to incorrect size and configuration labeling of the detachable coil system.

    Code Info

    Product Number: QC-4-12-HELIX UDI-DI (GTIN) Code: 00847536029590 Lot Number: B240079 Product Number: QC-10-30-3D UDI-DI (GTIN) Code: 00847536030138 Lot Number: B240084

    Distribution

    International distribution in the countries of China and Republic of Korea.

    Quantity

    96 systems