BEUDAMED
    FDA Recall Terminated

    Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.

    Recall: Z-0695-2022 · Initiated February 4, 2022

    Recall

    Recall Number
    Z-0695-2022
    Event Number
    89470
    FEI Number
    2183870
    Product Code
    MCW
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    February 4, 2022
    Posted
    March 7, 2022
    Terminated
    October 2, 2024
    Address
    ev3 Inc. 4600 Nathan Ln N, Plymouth, MN, 55442-2890

    Description

    Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. 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.

    Action

    The recalling firm began issuing the URGENT MEDICAL DEVICE NOTICE dated February 2022 on 2/4/2022 via 2-day UPS delivery. The letter explained the issue and instructed the consignee to adhere to the existing IFU instructions and warnings and precautions listed in the letter to reduce the risk of guidewire prolapse. The Customer Instructions included the notice was to be shared with all who needed to be aware within the consignee's organization or to any other organization where the product has been transferred; to review the IFU included with the product prior to use, noting the warnings and precautions listed in the notice; and to complete the Customer Confirmation Form to acknowledge receipt of the notice and that the appropriate action has been taken. It was to be emailed to the recalling firm.

    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

    245 devices