BEUDAMED
    FDA Recall 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 · Initiated May 23, 2016

    Recall

    Recall Number
    Z-2048-2016
    Event Number
    74276
    FEI Number
    2183870
    Product Code
    NIP
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    May 23, 2016
    Terminated
    September 22, 2017
    Address
    Ev3 Inc. 4600 Nathan Ln N, Plymouth, MN, 55442-2890

    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.

    Action

    Medtronic sent an "Urgent Medical Device Recall" letter dated May 2016, to all affected customers. The letter described the problem and the product involved in the recall. Consignees were instructed to identify, quarantine and return unused product to Medtronic. Consignees were requested to complete the Customer Confirmation Certificate and email it to RS.CFQFCAMedtronic.com or fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. Customers with questions were instructed to call 651-367-0612. For question regarding this recall call 763-398-7000.

    Distribution

    Nationwide Distribution to LA and WI.

    Quantity

    2