medical Class II Updated 2018-07-25

COVIDIEN MEDTRONIC recalls Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Si

Recalled Product

Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system 45 mm Vascular/Medium, Item Code SIG45ACTAVM


Hazard / Issue

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: N7L1049X & N7M0723X
View official government recall

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