BEUDAMED
    FDA Recall Terminated

    ev3 Primus GPS Biliary Stent System. Balloon Expandable Stent and Delivery System. The stent is made from a 316L stainless steel tube cut into an open lattice design. It is mounted onto a non-compliant balloon catheter. It is deployed and expanded by inflating the balloon.

    Recall: Z-0912-06 · Initiated March 8, 2006

    Recall

    Recall Number
    Z-0912-06
    Event Number
    34884
    FEI Number
    2183870
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 8, 2006
    Posted
    May 31, 2006
    Terminated
    February 3, 2007
    Address
    Ev3 Inc 4600 Nathan Ln N, Plymouth, MN, 55442-2890

    Description

    ev3 Primus GPS Biliary Stent System. Balloon Expandable Stent and Delivery System. The stent is made from a 316L stainless steel tube cut into an open lattice design. It is mounted onto a non-compliant balloon catheter. It is deployed and expanded by inflating the balloon.

    Reason

    A Primus device labeled (pouch and box) as a BXB35-05-17-120 contained a 6mm x 20mm catheter instead of the intended 5mm x 20mm catheter.

    Action

    ev3 field representatives visited all affected accounts. Product was retrieved a 'Field Action Form' was completed and a copy was left with the account.

    Distribution

    Only distributed in US to CA, FL, MA, MD, MS, NY, PA, TN, TX, WA, WV

    Quantity

    29