BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1552-2016 · Reported May 4, 2016

    Enforcement

    Recall Number
    Z-1552-2016
    Event ID
    73706
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ev3, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 4, 2016
    Initiation Date
    March 29, 2016
    Classification Date
    April 22, 2016
    Termination Date
    May 19, 2017
    Address
    3033 Campus Drive, N/A, Minneapolis, MN, 55441, United States

    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.

    Code Info

    A213373 and A216702

    Distribution

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

    Quantity

    27 (25 US, 2 OUS)