Recall Z-0821-2016— Medtronic

Name: FDA recall Z-0821-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-02

Class II · Terminated

Class II FDA medical device recall by Medtronic, initiated 2015-12-02, terminated 2019-07-18. It names one FDA 510(k) clearance: K111825. Product: Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL 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.. Reason: Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use.

Recalling firm: Medtronic
Classification: Class II
Status: Terminated
Initiated: 2015-12-02
Terminated: 2019-07-18
Firm location: North Haven, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K111825 — ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERSCovidien, Formerly US Surgical A Divison of Tyco H·cleared 2011-10-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL 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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.