Z-2436-2012Class II

Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit

Name: Z-2436-2012 Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit
Creator: Covidien LP
Published: 2012-08-21
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2012-08-21 / Terminated / root cause: design

FDA source

Covidien LP began a recall of Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit Product Code: DUET6035. Single Use Loading Unit (SULU) tissue reinforcement stapler. The... on 2012-08-21. FDA classified it as Class II and gives the reason as "Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2436-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-21
Posted: 2012-09-21
Terminated: 2016-08-30
Recalling firm: Medtronic, Inc.
Product: Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit Product Code: DUET6035. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Product code: GDW Staple, Implantable
Reason for recall: Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
Root cause tag: design
FDA root cause: Device Design
Action: Covidien issued an "URGENT MEDICAL DEVICE RECALL" letter dated August 21, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The firm sent a revised customer recall notification letter via FedEx overnight delivery to all customers who purchased Duet TRS" devices from August 2009- August 2012. This letter went to all customers whether they had been sent the August 21st letter or not. Users were advised that Covidien was recalling all lots of the Duet TRS Universal Straight and Articulating Single Use Loading Units (SULU). On August 23rd 2012, Covidien notified, via e-mail, perspective surgeons that were planning to participate in the "Duet TRS Patient Registry" of the recall and that as a result the Duet TRS registry program was discontinued. Customers were asked to complete and return a Recalled Product Form via fax to (800) 895-6140. Contact Covidien Customer Service at (800) 722-8772, option 1 for questions regarding this recall.
Quantity in commerce: 22,218 units
Distribution: Worldwide Distribution.
Product codes and lots: All lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2436-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2432-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-21
Z-2433-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-21
Z-2434-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-21
Z-2435-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-21
Z-2436-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-21
Z-2437-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-21
Z-2438-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-21
Z-2439-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-21

Product code GDW

K080898Class IIAuto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line ReinforcementTyco Healthcare Group LP / cleared 2008-05-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)