COVIDIEN MEDTRONIC recalls Tri-Staple 2.0 Intelligent Reload for use with Signia stapli
Recalled Product
Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Vascular/Medium, Item Code SIG30AVM
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
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