BEUDAMED
    FDA Enforcement Class I Terminated

    Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.

    Recall: Z-0694-2022 · Reported March 16, 2022

    Enforcement

    Recall Number
    Z-0694-2022
    Event ID
    89470
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    ev3 Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 16, 2022
    Initiation Date
    February 4, 2022
    Classification Date
    March 7, 2022
    Termination Date
    October 2, 2024
    Address
    4600 Nathan Ln N, N/A, Plymouth, MN, 55442-2890, United States

    Description

    Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.

    Reason

    The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.

    Code Info

    GTIN 00763000402396

    Distribution

    US Nationwide distribution in the states of AZ, CA, FL, IA, IL, KS, LA, MI, MS, NC, NJ, NY, OR, SC, SD, TN, TX, and VA.

    Quantity

    441 devices