BEUDAMED
    FDA Enforcement Class I Ongoing

    microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.

    Recall: Z-0312-2025 · Reported November 20, 2024

    Enforcement

    Recall Number
    Z-0312-2025
    Event ID
    95479
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    FHC, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 20, 2024
    Initiation Date
    October 4, 2024
    Classification Date
    November 8, 2024
    Address
    1201 Main St, N/A, Bowdoin, ME, 04287-7302, United States

    Description

    microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.

    Reason

    A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is too long relative to the size of other components was included in the build order for Lot 244517 of P/N 66-IT-06P. Use of the product with a spacer tube which is too long could result in intercranial hemorrhaging and brain damage.

    Code Info

    Package DI: 10873263004323; Contains DI Package: 00873263004326 LOT No. 244517

    Distribution

    Domestic distribution only to the following states: AZ, CA, PA, TN, TX, WA.

    Quantity

    8 packs of 5ea (40 total)