BEUDAMED
    FDA Recall Terminated

    VNUS Medical U-CLIP Removal Tool, UREM1860, is intended for the removal of U-Clip anastomotic devices.

    Recall: Z-1609-2008 · Initiated February 25, 2008

    Recall

    Recall Number
    Z-1609-2008
    Event Number
    47538
    Firm
    Medtronic Cardiac Surgery Technologies
    FEI Number
    3003368396
    Product Code
    FZP
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 25, 2008
    Posted
    September 16, 2008
    Terminated
    November 10, 2008
    Address
    7601 Northland Dr N, Minneapolis, MN, 55428-1088

    Description

    VNUS Medical U-CLIP Removal Tool, UREM1860, is intended for the removal of U-Clip anastomotic devices.

    Reason

    Medtronic has identified one lot #0610315 of U-Clip Removal Tools, Catalog UREM1860FW, that was incorrectly assembled. The nose cone attachment, on the body of the removal tool, may not contain sufficient adhesive, which can allow the nose cone to separate from the body of the device.

    Action

    A Medtronic "Urgent Medical Device Field Notification" letter was sent to one distributor and a separate consignee Medtronic letter "Urgent Medical Device Field Notification" was sent to end users on February 25, 2008. The letters explained the situation and requested that the impacted product be returned to Medtronic for disposal. The end user will be requested to complete a Recall certificate acknowledging the receipt of the information. If you have questions, contact your VNUS Sales Representative or Lauralie Millikan at 763-391-9124.

    Distribution

    AZ, GA, PA, MI, KY, FL, OH, TX, NY, VA, CA, MO IL.

    Quantity

    80