BEUDAMED
    FDA Recall Terminated

    ev3 The Endovascular Company, IntraCoil Self-Expanding Peripheral Stent, Model REF VT-6-60-135, Lot 4401214, Use Before 2010-07.

    Recall: Z-1816-2008 · Initiated April 9, 2008

    Recall

    Recall Number
    Z-1816-2008
    Event Number
    48102
    FEI Number
    2183870
    Product Code
    NIP
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    April 9, 2008
    Posted
    September 21, 2008
    Terminated
    May 27, 2009
    Address
    Ev3 Inc 4600 Nathan Ln N, Plymouth, MN, 55442-2890

    Description

    ev3 The Endovascular Company, IntraCoil Self-Expanding Peripheral Stent, Model REF VT-6-60-135, Lot 4401214, Use Before 2010-07.

    Reason

    An IntraCoil 6 mm x 40 mm stent was labeled as a 6 mm x 60 mm stent.

    Action

    ev3 representative visited the consignee on 4/15/08 and spoke to the physician at the site that used the device. A Device Recall Field Action Reconcilliation Form was requested.

    Distribution

    CA

    Quantity

    1