BEUDAMED
    FDA Recall Terminated

    ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W06040080. Peripheral Dilatation Catheter

    Recall: Z-1489-2014 · Initiated April 9, 2014

    Recall

    Recall Number
    Z-1489-2014
    Event Number
    68034
    FEI Number
    2183870
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    April 9, 2014
    Posted
    April 23, 2014
    Terminated
    October 6, 2014
    Address
    Ev3 Inc. 4600 Nathan Ln N, Plymouth, MN, 55442-2890

    Description

    ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W06040080. Peripheral Dilatation Catheter

    Reason

    Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a product labeling error. There is a discrepancy in the PTA Balloon length and the delivery catheter length printed on the product labeling.

    Action

    Consignees were sent a Covidien "Urgent Product Recall" letter dated April 09, 2014. The letter described the problem and the product involved in the recall. The letter described the required actions which included to immediately quarantine and discontinue use of the affected devices and to return affected product. Requested consignees to complete the Verification Form and return it to their Covidien Sales Representative. For questions they can contact Covidien Customer Service at 1-800-716-6000.

    Distribution

    Worldwide Distribution-USA including the states of WV, TX, OK, IN, NY, TX, and NC, and the countries of AUSTRALIA, ISRAEL, TURKEY, UNITED KINGDOM, ITALY, FRANCE, and CHINA.

    Quantity

    39 units (31 OUS, 8 US)