Medtronic product recalled over fire hazard

Recall date

December 2, 2015

Source

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

Official notice title

Medtronic recalls Best Practice Kits containing certain production lots of Endo GIA Ultra Universal Stapler Handles Product Usage: The En…

Recall number

Z-0822-2016

FDA classification

Class II

Brand / firm

Medtronic

Sold / distributed

Worldwide Distribution - US Nationwide and the countries of Canada, Albania, ALGERIA, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, E…

Why it was recalled

Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use

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

What was recalled

Best Practice Kits containing certain production lots of Endo GIA Ultra Universal Stapler Handles Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue.