BEUDAMED
    FDA Enforcement Class II Terminated

    Cordis EMPIRA NC RX PTCA Dilatation Catheter

    Recall: Z-2556-2014 · Reported September 3, 2014

    Enforcement

    Recall Number
    Z-2556-2014
    Event ID
    68834
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cordis Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 3, 2014
    Initiation Date
    June 23, 2014
    Classification Date
    August 28, 2014
    Termination Date
    December 14, 2016
    Address
    14201 Nw 60th Ave, N/A, Miami Lakes, FL, 33014-2802, United States

    Description

    Cordis EMPIRA NC RX PTCA Dilatation Catheter

    Reason

    The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. This may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery.

    Code Info

    63 Catalog numbers: 75R06200N, 75R06225N, 75R06250N, 75R06275N, 75R06300N, 75R06325N, 75R06350N, 75R06375N, 75R06400N, 75R10200N, 75R10225N, 75R10250N, 75R10275N, 75R10300N, 75R10325N, 75R10350N, 75R10375N, 75R10400N, 75R12200N, 75R12225N, 75R12250N, 75R12275N, 75R12300N, 75R12325N, 75R12350N, 75R12375N, 75R12400N, 75R15200N, 75R15225N, 75R15250N, 75R15275N, 75R15300N, 75R15325N, 75R15350N, 75R15375N, 75R15400N, 75R20200N, 75R20225N, 75R20250N, 75R20275N, 75R20300N, 75R20325N, 75R20350N, 75R20375N, 75R20400N, 75R25200N, 75R25225N, 75R25250N, 75R25275N, 75R25300N, 75R25325N, 75R25350N, 75R25375N, 75R25400N, 75R25200N, 75R25225N, 75R25250N, 75R25275N, 75R25300N, 75R25325N, 75R25350N, 75R25375N, and 75R25400N.

    Distribution

    Worldwide Distribution - USA including Puerto Rico and the states of AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WY and Hawaii., and the countries of Argentina, Brazil, Canada, Chile, Colombia, Mexico, Panama and Venezuela.

    Quantity

    250,000 units