COVIDIEN MEDTRONIC recalls Tri-Staple 2.0 Black Intelligent Reload for use with Signia
Recalled Product
Tri-Staple 2.0 Black Intelligent Reload for use with Signia stapling system 60 mm Extra Thick, Item Code SIG60AXT
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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