BEUDAMED
    FDA Recall Terminated

    Protege GPS Biliary System (6Fr 10mm x 30mm) - Product number SERB65-10-30-120 (.035) (Biliary)

    Recall: Z-1330-04 · Initiated July 9, 2004

    Recall

    Recall Number
    Z-1330-04
    Event Number
    29629
    FEI Number
    2183870
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 9, 2004
    Posted
    August 7, 2004
    Terminated
    December 28, 2006
    Address
    Ev3 4600 Nathan Ln N, Plymouth, MN, 55442-2890

    Description

    Protege GPS Biliary System (6Fr 10mm x 30mm) - Product number SERB65-10-30-120 (.035) (Biliary)

    Reason

    Ev3 had received customer complaints indicating that the stent device could not be used with an .035' guidewire. An investigation found that 6Fr, 135 cm (.018') stent system were labeled as a 120 cm (.035') stent system and that 6Fr 120 cm (.035') were labeled as 6Fr, 135 cm (.018').

    Action

    Send notification letter to direct accounts and an EV3 representative will contact the direct account within the next few days to arrrange for the return of all unused product.

    Distribution

    Eleven (11) devices were distributed to seven (7) U.S. customers. Ten (10) devices were distributed to seven (7) clinical study sites in the U.S.

    Quantity

    11