BEUDAMED
    FDA Recall Terminated

    ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 5mm x 18mm 80 cm .014" REF PMB 4-5-18-80

    Recall: Z-0613-04 · Initiated January 29, 2004

    Recall

    Recall Number
    Z-0613-04
    Event Number
    28210
    FEI Number
    2183870
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 29, 2004
    Posted
    July 20, 2004
    Terminated
    November 8, 2005
    Address
    ev3 Inc. 651 Campus Dr, Saint Paul, MN, 55112-3495

    Description

    ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 5mm x 18mm 80 cm .014" REF PMB 4-5-18-80

    Reason

    After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.

    Action

    A recall letter was sent by Fed Ex to all affected customers for delivery on 01/30/04. Follow-up and product retrieval was done by the firm''s representatives.

    Distribution

    The product was distributed nationwide in the United States and internationally to China and Ireland.

    Quantity

    446