BEUDAMED
    FDA Enforcement Class II Terminated

    FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree.

    Recall: Z-1507-2013 · Reported June 12, 2013

    Enforcement

    Recall Number
    Z-1507-2013
    Event ID
    65182
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cordis Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2013
    Initiation Date
    April 23, 2013
    Classification Date
    June 6, 2013
    Termination Date
    June 27, 2014
    Address
    14201 Nw 60th Ave, N/A, Miami Lakes, FL, 33014-2802, United States

    Description

    FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree.

    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.

    Code Info

    27 Catalog Numbers FLX-50030-B1, FLX-60030-B1, FLX-70030-B1, FLX-80030-B1, FLX-50040-B1, FLX-60040-B1, FLX-70040-B1, FLX-80040-B1, FLX-50060-B1, FLX-60060-B1, FLX-70060-B1, FLX-80060-B1, FLX-50080-B1, FLX-60080-B1, FLX-70080-B1, FLX-80080-B1, FLX-50100-B1, FLX-60100-B1, FLX-70100-B1, FLX-80100-B1, FLX-50120-B1, FLX-60120-B1, FLX-70120-B1, FLX-80120-B1, FLX-60150-B1, FLX-70150-B1, FLX-80150-B1

    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

    23 units