BEUDAMED
    FDA Recall Terminated

    ev3 Protg EverFlex Self-Expanding Biliary Stent System, Sterile EO, (REF: PRB35-06-150-080, REF PRB35-06-120-120 and PRB35-06-150-120), 4.5 - 5.5mm, Expiration: 2011-10-01, Rx only. ev3 Inc., 4500 Nathan Lane North, Plymouth, MN 55442-2929. Intended as a palliative treatment of malignant neoplasms in the biliary tree.

    Recall: Z-1598-2010 · Initiated March 31, 2010

    Recall

    Recall Number
    Z-1598-2010
    Event Number
    55303
    FEI Number
    2183870
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    March 31, 2010
    Posted
    May 13, 2010
    Terminated
    March 8, 2012
    Address
    Ev3 Inc. 4600 Nathan Ln N, Plymouth, MN, 55442-2890

    Description

    ev3 Protg EverFlex Self-Expanding Biliary Stent System, Sterile EO, (REF: PRB35-06-150-080, REF PRB35-06-120-120 and PRB35-06-150-120), 4.5 - 5.5mm, Expiration: 2011-10-01, Rx only. ev3 Inc., 4500 Nathan Lane North, Plymouth, MN 55442-2929. Intended as a palliative treatment of malignant neoplasms in the biliary tree.

    Reason

    ev3 is conducting a voluntary recall on three lots of the Protg EverFlex" Biliary Stent System. They determined that a lot of 120mm Protg EverFlex" Biliary Stent system may contain a 150mm length Self-Expanding stent and two lots o 150mm Protg EverFlex" Biliary Stent System may contain a 120 mm length Self-Expanding stent.

    Action

    ev3 issued "Medical Device Recall" notifications dated March 31, 2010 addressed to "Dear Risk Manager or Cath Lab Manager". Each letter addressed the affected product. Users were instructed to locate and remove from use the affected product and a sales representative will be in contact shortly to arrange for return. For further information, contact ev3 Customer Service at 1-800-716-6700.

    Distribution

    Nationwide Distribution -- CA, FL, IL, LA, MA, MI, NH, PA, TN, TX, UT, VA and WA.

    Quantity

    19