BEUDAMED
    FDA Recall Terminated

    ev3 The Endovascular Company, Protege GPS 6mm x 80mm Self Expanding Biliary Stent System, Rx Only, and SERB65-06-80-120. In the US, the intended as a palliative treatment of malignant neoplasms in the biliary tree. Outside the US, the intended for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA) or lesions believed to be at high risk for restenosis following PTA in the common and external iliac, subclavian or renal arteries.

    Recall: Z-2023-2009 · Initiated June 10, 2009

    Recall

    Recall Number
    Z-2023-2009
    Event Number
    52642
    FEI Number
    2183870
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    June 10, 2009
    Posted
    September 8, 2009
    Terminated
    December 11, 2011
    Address
    Ev3 Inc. 4600 Nathan Ln N, Plymouth, MN, 55442-2890

    Description

    ev3 The Endovascular Company, Protege GPS 6mm x 80mm Self Expanding Biliary Stent System, Rx Only, and SERB65-06-80-120. In the US, the intended as a palliative treatment of malignant neoplasms in the biliary tree. Outside the US, the intended for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA) or lesions believed to be at high risk for restenosis following PTA in the common and external iliac, subclavian or renal arteries.

    Reason

    ev3 Inc. is conducting a voluntary recall of specific lots of the Protege GPS Self-Expanding Stent System because labeling did not match the actual stent size contained in the package. The affected product was labeled as a 6mm x 80mm Protege GPS stent but actually contained an 8mm x 40mm stent. This situation can lead to vessel damage or inadequate coverage of the target lesion.

    Action

    Consignees were emailed a letter with a subject heading of "Medical Device Recall". The e-mail was dated June 10, 2009. The letter informed the consignee of the problem and product involved. They requested that any affected devices remaining in inventory be identified and returned and to fill out and return the "Device Recall Field Action Reconciliation Form".

    Distribution

    International Distribution Only -- Brazil, Uruguay, & Malaysia.

    Quantity

    5