BEUDAMED
    FDA Recall Terminated

    Medtronic U-CLIP Anastomotic Device Removal Tool, model REM1860FW. The U-Clip Anastomotic Device Removal Tool is designed to remove U-Clip Anastomotic Devices.

    Recall: Z-0968-2007 · Initiated February 8, 2007

    Recall

    Recall Number
    Z-0968-2007
    Event Number
    37300
    Firm
    Medtronic Cardiac Surgery Technologies
    FEI Number
    3003368396
    Product Code
    FZP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 8, 2007
    Posted
    June 27, 2007
    Terminated
    February 24, 2008
    Address
    7601 Northland Dr N, Minneapolis, MN, 55428-1088

    Description

    Medtronic U-CLIP Anastomotic Device Removal Tool, model REM1860FW. The U-Clip Anastomotic Device Removal Tool is designed to remove U-Clip Anastomotic Devices.

    Reason

    Six lots of U-Clip Removal Tools, catalog REM1860FW were incorrectly assembled. The nose cone attachment to the body of the removal tool does not contain sufficient adhesive which can cause the nose to separate from the body of the device.

    Action

    Customers to be notified via a letter on 2/8/07. The letter will explain the situation and requests that the impacted product be returned to Medtronic for disposal. The customer will be requested to complete a "Recall Certificate" acknowledging the receipt of this information.

    Distribution

    Nationwide and Canada.

    Quantity

    187 (US 155, OUS 32)