BEUDAMED
    FDA Recall Open, Classified

    EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.

    Recall: Z-1322-2022 · Initiated May 13, 2022

    Recall

    Recall Number
    Z-1322-2022
    Event Number
    90362
    FEI Number
    1219930
    Product Code
    GAG
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    May 13, 2022
    Address
    LP 60 Middletown Ave, Covidien, North Haven, CT, 06473-3908

    Description

    EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.

    Reason

    The affected staplers have the potential for the staple guide to not be securely attached to the instrument. The issue could cause the component to disengage and if disengaged, could allow the device to transect tissue without forming staples.

    Action

    Beginning 13-MAY-2022 communications to all affected consignees began. In the United States notifications are set via UPS 2-day delivery. Customers should return all unused affected product in inventory to Medtronic. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been transferred. Consignees are asked to complete and return a confirmation certificate (or equivalent record) confirming they have received the notification.

    Distribution

    Worldwide distribution - US Nationwide.

    Quantity

    433,560