Covidien, LP: Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Covidien, LP
- Product
- Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2025-09-25
- Code info
- CFN: SIGSDL45CTVT; UDI-DIs: (1) 20884521741840, (2) 10884521741843; Lot numbers: N5F1971Y, N5F1723Y, N5D1858UY, N5B1134UY;
- Product quantity
- 3263 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- North Haven
- State
- CT
- Country
- United States
- Event id
- 97792
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