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Recall Observatory FDA recall evidence

Device product

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

Z-0485-2026

September 25, 2025

Class II

Product summary

Firm
Covidien, LP
Event
Event 97792
Status
Ongoing
Classification
Class II
Quantity
3263 units
Official record key
device-enforcement:Z-0485-2026

Official wording

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.

Code information: CFN: SIGSDL45CTVT; UDI-DIs: (1) 20884521741840, (2) 10884521741843; Lot numbers: N5F1971Y, N5F1723Y, N5D1858UY, N5B1134UY;

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.