FDA (Devices) recall action 80423
The FDA (Devices) publishes a recall like this one as 14 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 14 pages.
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.
The agency’s own wording, quoted from the enforcement report.
Medtronic is recalling Tri-Staple 2.0 Intelligent Reloads because a missing sled component may prevent staple formation, leading to bleeding or leakage.
Medtronic is recalling Endo GIA staplers that may be missing a sled component, which could cause staple line failure, bleeding, or leakage during surgery.
Medtronic is recalling specific Endo GIA 45mm Vascular Reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
COVIDIEN MEDTRONIC is recalling Endo GIA 60 mm Articulating Vascular/Medium Loading Units because a missing sled component may prevent staple formation, leading to bleeding or leakage.
Medtronic is recalling specific Endo GIA 45 mm Extra Thick Black Articulating Reloads because a missing sled component may prevent staple formation, potentially leading to bleeding or leakage.
Medtronic is recalling specific Endo GIA 60 mm reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
Medtronic is recalling Tri-Staple 2.0 Curved Tip Intelligent Reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
Medtronic is recalling specific Endo GIA 45mm reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
COVIDIEN MEDTRONIC is recalling Endo GIA 45 mm Articulating Medium/Thick Reloads because a missing sled component may prevent staple formation, leading to bleeding or leakage.
Medtronic is recalling specific Tri-Staple 2.0 Curved Tip Intelligent Reloads because a missing sled component may prevent staple formation, potentially leading to bleeding or leakage.
Medtronic is recalling Tri-Staple 2.0 Curved Tip Intelligent Reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
Medtronic is recalling specific Endo GIA 60 mm reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
Medtronic is recalling Tri-Staple 2.0 Black Intelligent Reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
Medtronic is recalling Tri-Staple 2.0 Intelligent Reloads because a missing sled component may prevent staple formation, leading to bleeding or leakage.