BEUDAMED
    FDA Enforcement Class II 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 · Reported April 30, 2014

    Enforcement

    Recall Number
    Z-1489-2014
    Event ID
    68034
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ev3, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 30, 2014
    Initiation Date
    April 9, 2014
    Classification Date
    April 23, 2014
    Termination Date
    October 6, 2014
    Address
    4600 Nathan Ln N, N/A, Plymouth, MN, 55442-2890, United States

    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.

    Code Info

    AB35W06120135 Lot: 9855406 Use by: 2017-01-16 AB35W06040080 Lot: 9852591 Use by: 2017-01-16

    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)