Covidien LP: DUET TRS 60 4.8MM ARTICULATING SULU Product Code: DUET6048A Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. When used with the ENDO GIA Universal and Ultra Staplers, the Duet TRS Reloads with Biosyn tissue reinforcement place two, triple-staggered rows titanium staples while simultaneously dividing the tissue and anchoring the preloaded Biosyn reinforcement material. The preloaded reinforcement material Is fully detached from the SULU upon complete firing of the length of the cartridge. The Duet TRS reinforcement material (Biosyn) Is a synthetic absorbable film prepared from synthetic polyester composed of glycolide, dioxanone, and trimethylene carbonate.

Recall number

Z-0998-2012

Recalling firm

Covidien LP

Product

DUET TRS 60 4.8MM ARTICULATING SULU Product Code: DUET6048A Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. When used with the ENDO GIA Universal and Ultra Staplers, the Duet TRS Reloads with Biosyn tissue reinforcement place two, triple-staggered rows titanium staples while simultaneously dividing the tissue and anchoring the preloaded Biosyn reinforcement material. The preloaded reinforcement material Is fully detached from the SULU upon complete firing of the length of the cartridge. The Duet TRS reinforcement material (Biosyn) Is a synthetic absorbable film prepared from synthetic polyester composed of glycolide, dioxanone, and trimethylene carbonate.

Status

Terminated

Initiated

2012-01-12

Posted

2012-02-13

Terminated

2016-08-24

Reason

Duet TRS Straight and Articulating Single Use (SULU)Loading Staplers used in thoracic surgery may result in serious injury or death

Root cause

Under Investigation by firm

Action

Covidien issued an Urgent Medical Device Recall letter dated January 12, 2012 to all affected customers. The letter identified the affected products, problem, and actions to be taken. Customers were instructed to immediately discontinue use of the device in thoracic surgery, Immediately advise all surgeons/surgery personnel of this recall and return products intended for thoracic use to Covidien by contacting Customer Service at SDFeedback@Covidien.com or 1-800-722-8772, option 1, to obtain a Return Goods Authorization prior to returning the affected units. Customers were advised to complete the Recall product return form in its entirety and return it with the returned units. For questions contact your Covidien representative or Quality Assurance at 203-492-5232.

Quantity

220,622 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of: ¿esk¿ republika, ASSAGAY, Australia, Austria, Belgium, Bosnia, Herzegovina, Bulgaria Cairo,Egypt, Canada, Canary Islands, China, Croatia, Cyprus, Czech Republic, Denmark, Egypt, England, Finland, France, Germany, Guadeloupe, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kingdom of Bahrain, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Luxembourg, Nederland, Nelspruit, New Redruth, New Zealand, Norway, Nouvelle Caledonie, Philippines, Poland, Portugal, Qatar, Reunion, Russia, Romania, Rustenburg, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Taiwan, Thailand, Tunisia, Uae, Uae - Dubai, Umhlanga Rocks, United Kingdom, Vietnam and Wales.

Lot, serial or model codes

All lots

510(k) numbers

["K080898"]

PMA numbers

not on file

Product code

GDW

Firm FEI

1219930

Firm city

North Haven

Firm state

CT

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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