BEUDAMED
    FDA Recall Terminated

    ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.

    Recall: Z-1552-2016 · Initiated March 29, 2016

    Recall

    Recall Number
    Z-1552-2016
    Event Number
    73706
    Firm
    ev3, Inc.
    FEI Number
    3008114455
    Product Code
    LIT
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    March 29, 2016
    Posted
    April 22, 2016
    Terminated
    May 19, 2017
    Address
    3033 Campus Drive, Minneapolis, MN, 55441

    Description

    ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.

    Reason

    Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.018" Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter because the product is mislabeled.

    Action

    Consignees were sent on 3/29/2016 a Medtronic "Urgent Medical Device Recall" letter dated March 2016. The letter was addressed to Risk Manger or Health Care Professional. The letter described the problem and the product involved in the recall.

    Distribution

    US: CA, GA, LA, MI, MS, MO,NV,NH. NY, OH, PA, SD, TX. OUS: SINGAPORE

    Quantity

    27 (25 US, 2 OUS)