BEUDAMED
    FDA Recall Open, Classified

    Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT

    Recall: Z-1228-2023 · Initiated January 25, 2023

    Recall

    Recall Number
    Z-1228-2023
    Event Number
    91650
    FEI Number
    1219930
    Product Code
    GDW
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    January 25, 2023
    Posted
    March 6, 2023
    Address
    LP 60 Middletown Ave, Covidien, North Haven, CT, 06473-3908

    Description

    Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT

    Reason

    Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These conditions may be associated to a delay to treatment, unspecified infection, hemorrhage/blood loss/bleeding, failure to anastomose, peritonitis, sepsis, pneumothorax, tissue trauma, or death.

    Action

    On January 25, 2023, the firm notified customers via Urgent Medical Device Recall letter. Customers were asked to take the following immediate actions: 1. Identify and quarantined all unused affected product. 2. Return unused affected product to Medtronic using the Customer Confirmation Form. 3. Forward the information to all who need to be aware within your organization, or to any organization where the affected product was transferred. There are no additional actions required for patients where a stapler in scope of this recall was used during a procedure. These patients should continue to be monitored in accordance with your medical facility s standard care protocols. If you have any questions regarding this communication, please contact your Medtronic Representative Customer Service at 800-962-9888, option 2.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of Arkansas, California, Florida, Georgia, Louisiana, Massachusetts, New York, North Carolina, Ohio, Washington and the countries of Australia, Austria, Belgium, Canada, Canary Islands, Denmark, Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, New Caledonia, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom.

    Quantity

    264 US; 5056 OUS