BEUDAMED
    FDA Recall Terminated

    ev3" sterile EO, single Use, Visi-Pro Balloon-Expandable Biliary Stent System. Model Numbers: PXB35-06-27-135, PXB35-06-37-080, PXB35-07-37-080, PXB35-08-17-080 , PXB35-08-27-135 , PXB35-08-37-135, PXB35-08-57-080, and PXB35-09-17-135 4800. The Endovascular Company, Nathan Lane North, Plymouth, MN 55442-2920,

    Recall: Z-1548-2008 · Initiated July 1, 2008

    Recall

    Recall Number
    Z-1548-2008
    Event Number
    49366
    FEI Number
    2183870
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    July 1, 2008
    Posted
    September 26, 2008
    Terminated
    December 10, 2011
    Address
    Ev3 Inc 4600 Nathan Ln N, Plymouth, MN, 55442-2890

    Description

    ev3" sterile EO, single Use, Visi-Pro Balloon-Expandable Biliary Stent System. Model Numbers: PXB35-06-27-135, PXB35-06-37-080, PXB35-07-37-080, PXB35-08-17-080 , PXB35-08-27-135 , PXB35-08-37-135, PXB35-08-57-080, and PXB35-09-17-135 4800. The Endovascular Company, Nathan Lane North, Plymouth, MN 55442-2920,

    Reason

    ev3, Inc. has determined that specific lots of the Visi-Pro" BE Stent system may not have adequate securement of the stent to the delivery system and may have a larger diameter/profile than intended.

    Action

    Consignees were sent a "Medical Device Recall" letter dated 7/1/08. The letter described the product, problem and action to be taken. The letter also requested to complete and return The Field Action Reconciliation Form. For further information, please contact Customer Service at 800-716-6700.

    Distribution

    Worldwide Distribution including states of AL,AZ, CA, CO, CT, FL, IL, IN, IA, KS, KY, LA,ME, MA, MI, MN, MO, MT, NJ, NY, NC, OH, OR, PA, RI, SC, TN, TX, WV, WI, and VA. Counties of SWEDEN, TUNISIA, SWITZERLAND, GERMANY, ITALY, SLOVENIA, FRANCE, BELGIUM, UNITED KINGDOM, TURKEY, FINLAND, LITHUANIA, and NORWAY.

    Quantity

    212