BEUDAMED
    FDA Recall Terminated

    FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.

    Recall: Z-1511-2013 · Initiated April 23, 2013

    Recall

    Recall Number
    Z-1511-2013
    Event Number
    65182
    Firm
    Cordis Corporation
    FEI Number
    1016427
    Product Code
    NIP
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    April 23, 2013
    Posted
    June 6, 2013
    Terminated
    June 27, 2014
    Address
    14201 Nw 60th Ave, Miami Lakes, FL, 33014-2802

    Description

    FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.

    Reason

    Holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch.

    Action

    Cordis sent an Urgent Medical Device Correction and Potential Removal letter dated April 24, 2013 e-mail to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately identify and set aside all affected products to prevent further use of the affected product, until inspected. Use only product identified with a blue dot next to the lot number on the carton face label, carton end label, and outer pouch label, or product with upgraded sterile barrier system (not yet available, as of the date of this letter), review, complete, sign and return the enclosed Acknowledgement Form and maintain a copy of this notice with the affected product. For questions related to the issue, please contact our FSS/Cordis representative, or please contact Cordis Direct at (800) 781-0282, Monday through Friday from 9:00 AM to 5:00 PM EDT.

    Distribution

    Worldwide Distribution - USA (nationwide) and the states of: AZ, CA, CT, FL, GA, IA, IL, LA, MD, MI, MS, NC, NJ, NY, OH, PA, RI, SC, TX, WA, WI, WV, and the countries of: Czech Republic, Italy, Netherlands, and New Zealand

    Quantity

    310 units