Covidien, LP
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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.
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
CFN: SIGSDL45CTVT; UDI-DIs: (1) 20884521741840, (2) 10884521741843; Lot numbers: N5F1971Y, N5F1723Y, N5D1858UY, N5B1134UY;
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →