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COVIDIEN MEDTRONIC recalls Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system 45 mm Vascular/Medium, Item Code SIG45A
Recalled July 25, 2018 · FDA recall Z-2515-2018 · COVIDIEN MEDTRONIC
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. · FDA Class II
Sold at
Nationwide U.S.A. Internationally to: Albania, Algeria, Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hungary, Iceland, Ireland, Israel, Italy, Ivory Coast, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Malta, Martinique, Moldova, Morocco, Namibia, Netherlands, New Caledonia, Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates & United Kingdom
Description
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.
Product
Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system 45 mm Vascular/Medium, Item Code SIG45ACTAVM
Manufacturer(s)
COVIDIEN MEDTRONIC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →