Z-1227-2012

Covidien Duet TRS Articulating 60- 3.5MM, Single Use Loading Unit Ref: DUET6035A The ENDO GIA Universal...

Name: Z-1227-2012 Covidien Duet TRS Articulating 60- 3.5MM, Single Use Loading Unit Ref: DUET6035A The ENDO GIA Universal...
Creator: Covidien LP
Published: 2012-02-16
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2012-02-16 / Terminated / root cause: manufacturing process

FDA source

Covidien LP began a recall of Covidien Duet TRS Articulating 60- 3.5MM, Single Use Loading Unit Ref: DUET6035A The ENDO GIA Universal Staplers with DUET TR S Loading Units have applications... on 2012-02-16. The reason FDA records is "Missing component results in the stapler not firing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1227-2012
Status: Terminated
Initiated: 2012-02-16
Posted: 2012-03-19
Terminated: 2021-03-04
Recalling firm: Medtronic, Inc.
Product: Covidien Duet TRS Articulating 60- 3.5MM, Single Use Loading Unit Ref: DUET6035A The ENDO GIA Universal Staplers with DUET TR S Loading Units have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis. They may be used for transaction 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: Missing component results in the stapler not firing.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Covidien, sent a "Medical Device Recall" letter dated February 16, 2012 to customers via federal express. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of Lot# N1H003LX of Duet TRS Articulating Loading Unit and segregate affected product; return inventory to Field Returns Department, 195 McDermott Road, North Haven, CT 06473 and contact customer service at [email protected] or (800) 722-8772, option #1 for RGA # prior to returning; and complete and return the Recall Product Return Form via fax to (203) 822-6009 (all affected units must be returned with completed form through the Distributor). If you have any questions or concerns, please do not hesitate to contact your Covidien representative or Quality Assurance at 203-492-5232, or Customer Service at 800-722-877 option 1 customer service.
Quantity in commerce: 1158 units
Distribution: Worldwide distribution: USA (nationwide) and country of: Venezuela.
Product codes and lots: Lot Number: N1H0037LX

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)