BEUDAMED
    FDA Enforcement Class III Terminated

    Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35

    Recall: Z-3253-2018 · Reported October 3, 2018

    Enforcement

    Recall Number
    Z-3253-2018
    Event ID
    80919
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Vascular
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 3, 2018
    Initiation Date
    August 16, 2018
    Classification Date
    September 26, 2018
    Termination Date
    May 7, 2021
    Address
    35-37A Cherry Hill Drive, Danvers, MA, 01923-2565, United States

    Description

    Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35

    Reason

    Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the pouch are the correct U5TRAN35 item, the outer carton has all the correct labeling, and all the other information and configuration details on both the carton and the pouch are correct.

    Code Info

    UDI/GTIN: 20643169738717 Lot Number 60068186

    Distribution

    CA, IA, NE, TN, TX, VA, WA, Jamaica, New Zealand, Thailand

    Quantity

    250 units