BEUDAMED
    FDA Recall Terminated

    EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis.

    Recall: Z-0070-2019 · Initiated August 17, 2018

    Recall

    Recall Number
    Z-0070-2019
    Event Number
    81043
    Firm
    COVIDIEN LLC
    FEI Number
    1282497
    Product Code
    GAG
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    August 17, 2018
    Terminated
    April 10, 2020
    Address
    15 Hampshire St, Mansfield, MA, 02048-1113

    Description

    EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis.

    Reason

    The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following application potentially leading to bleeding, anastomotic leak or tissue trauma. There have been no reports of serious injury related to this issue.

    Action

    All U.S. consignees were notified via Federal Express or certified mail on August 17, 2018. The letter informs customers of the potential for use of a device to have an incorrect tissue gap. Required Actions: 1. Please quarantine and discontinue use of the affected item code and lots listed above. 2. Please return affected product. All unused products from the affected item codes and lots must be returned. If you purchased directly from Medtronic, return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. If you purchased from a distributor, complete all fields on the form and contact your distributor directly to arrange for return of product. 3. If you have distributed EEA" staplers with Tri-Staple" technology listed above, please promptly forward the information from this letter to those recipients. 4. Complete the Recalled Product Return Form even if you do not have inventory. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.

    Distribution

    Worldwide Distribution - US Nationwide in the states of CA, FL, IL, NC, NY, UT. and the countries of Austria, Belgium, Denmark, Finland, France, Germany, Iceland, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Reunion, Spain, Sweden, Switzerland, and United Kingdom.

    Quantity

    1,902