VATS lobectomy stapler boxes recalled over a malformed cover tube press
Covidien is recalling two units of a VATS lobectomy box containing the Signia Small Diameter Curved Tip Intelligent Reload because internal components may move during firing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: uncontrolled motion during firing of a surgical stapler is a hazard, and no injuries are reported.
Plain-English summary
The Covidien Signia Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin), supplied in the BOX LOBECTOMIA VATS 3D, CFN BOX06170V4, is being recalled.
A manufacturing issue could lead to a malformed cover tube press, which can lead to internal components' movement during firing, creating the potential for uncontrolled motion.
The record lists 2 units, outside the United States only, carrying UDI-DI 00763000988975 from lot 0231961695. Distribution was worldwide, including nationwide in the United States and to Austria, Belgium, Chile, Estonia, Finland and France. The FDA has classified the action as Class II.
Uncontrolled motion in a stapler during firing is a hazard to the tissue being stapled. The enforcement record reports no injuries. Facilities should quarantine affected lots and follow Covidien's instructions.
The recalled product
- Product
- Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;
- Manufacturer
- Covidien, LP
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- CFN: BOX06170V4
- UDI-DI: 00763000988975
- Lot numbers: 0231961695
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Covidien, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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