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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien Duet TRS Loading Unit

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  Class 2 Device Recall Covidien Duet TRS Loading Unit see related information
Date Initiated by Firm August 21, 2012
Date Posted September 21, 2012
Recall Status1 Terminated 3 on August 30, 2016
Recall Number Z-2433-2012
Recall Event ID 63015
510(K)Number K080898  
Product Classification Staple, implantable - Product Code GDW
Product Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit.
Product Code: DUET4535A.

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.
Code Information All lot numbers
Recalling Firm/
Manufacturer		 Covidien LP
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact Sandra DePonte
203-492-8165
Manufacturer Reason
for Recall		 Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.
FDA Determined
Cause 2		 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 94,301 units
Distribution Worldwide Distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GDW and Original Applicant = TYCO HEALTHCARE GROUP, LP
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