BEUDAMED
    FDA Enforcement Class II Terminated

    EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. The Protege EverFiex" Self-expanding Peripheral Stent System is a self-expanding Nitinol stent system intended for permanent implantation. The self-expanding stent is made of a nickel titanium alloy (Nitinol) and comes pre-mounted on a 6 F, 0.035" over-the-wire delivery system. The stent is cut from a Nitinol tube in an open lattice design, and has tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency

    Recall: Z-2048-2016 · Reported June 29, 2016

    Enforcement

    Recall Number
    Z-2048-2016
    Event ID
    74276
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ev3, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 29, 2016
    Initiation Date
    May 23, 2016
    Classification Date
    June 23, 2016
    Termination Date
    September 22, 2017
    Address
    4600 Nathan Ln N, N/A, Plymouth, MN, 55442-2890, United States

    Description

    EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. The Protege EverFiex" Self-expanding Peripheral Stent System is a self-expanding Nitinol stent system intended for permanent implantation. The self-expanding stent is made of a nickel titanium alloy (Nitinol) and comes pre-mounted on a 6 F, 0.035" over-the-wire delivery system. The stent is cut from a Nitinol tube in an open lattice design, and has tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency

    Reason

    Medtronic is issuing a medical device recall to return product potentially associated with an outer box mislabel issue for two Protege EverFiex" Self-expanding Peripheral Stent Systems, model PRB35-08-040- 080, from lot A164580. The size on the outer box is labeled as 8x40x80mm while potentially containing a 6x40x120mm device as indicated by both the inner pouch and device labels. This potential issue is limited to two EverFiex stent system devices from lot A164580 that were repackaged by Medtronic and distributed. This does not affect any other Medtronic product or implantable devices.

    Code Info

    lot: A164580

    Distribution

    Nationwide Distribution to LA and WI.

    Quantity

    2