Covidien LLC recalls Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have applica…

Recall date

September 15, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0908-2018

FDA classification

Class II

Brand / firm

Covidien LLC

Sold / distributed

Internationally, including Japan. No USA Customers

Why it was recalled

The device cartridge disengaged during use due to manufacturing error.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.