BEUDAMED
    FDA Enforcement Class II Terminated

    Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for post- dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

    Recall: Z-0998-2015 · Reported January 28, 2015

    Enforcement

    Recall Number
    Z-0998-2015
    Event ID
    70080
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cordis Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 28, 2015
    Initiation Date
    December 22, 2014
    Classification Date
    January 16, 2015
    Termination Date
    July 9, 2015
    Address
    14201 Nw 60th Ave, N/A, Miami Lakes, FL, 33014-2802, United States

    Description

    Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for post- dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

    Reason

    One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized.

    Code Info

    Catalog 4400615X, demo lot 15617883

    Distribution

    Nationwide Distribution: US including states of: CT, NJ, NY, PA, MD, VA, WV, NC, SC, GA, FL, AL, TN, MS, KY, OH, IN, MI, IA, WI, SD, IL, MO, KS, NE, LA, OK, TX, CO, UT, AZ, CA, OR, WA, AR, IN, MN, WY, ND, NV, MA, RI, NH, CT, DE, District of Columbia and Hawaii.

    Quantity

    120