FDAMay 22, 2018device

Endo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA60AXT

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

covidien medtroniccovidien

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Endo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA60AXT — Recall Details · AllClear