Medical Device Recall: Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
Covidien, LP · September 25, 2025
Reason for Recall
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.
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.
States Affected
NATIONWIDE
Quantity Affected
3263 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0485-2026
Status: ongoing
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