BEUDAMED
    FDA Recall Open, Classified

    Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;

    Recall: Z-0485-2026 · Initiated September 25, 2025

    Recall

    Recall Number
    Z-0485-2026
    Event Number
    97792
    FEI Number
    1219930
    Product Code
    GDW
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    September 25, 2025
    Posted
    November 7, 2025
    Address
    LP 60 Middletown Ave, Covidien, North Haven, CT, 06473-3908

    Description

    Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;

    Reason

    A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.

    Action

    On September 25, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Customer actions: Identify and quarantine all unused impacted product listed. Return all quarantined devices to Medtronic. If purchased from a distributor, contact your distributor directly to arrange for the return of the devices back to your distributor. Please complete and return the enclosed Customer Confirmation Form. Pass on this notice to all those who need to be aware within your organization or to any organization where the listed affected lots may have been transferred or distributed.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Chile, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Kuwait, Malaysia, Netherlands, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, United Kingdom.

    Quantity

    3263 units