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Covidien LLC recalls Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have app
Recalled March 14, 2018 · FDA recall Z-0908-2018 · Covidien
Hazard
The device cartridge disengaged during use due to manufacturing error. · FDA Class II
Units
163
Sold at
Internationally, including Japan. No USA Customers
Description
The device cartridge disengaged during use due to manufacturing error.
Product
Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, e.g. low anterior resection. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Manufacturer(s)
Covidien LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →