FDA Recalls Covidien Duet TRS Staplers Due to Injury Risk
The FDA is recalling 433,528 units of the Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit because the device may injure adjacent anatomical structures.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and the source text explicitly states the device may result in 'life threatening post-operative complications,' which aligns with the rubric criteria for Severe (4) involving significant injury reports or high-risk medical device defects.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit (Product Code: DUET4535). This medical device is a Single Use Loading Unit (SULU) tissue reinforcement stapler used in abdominal, gynecologic, and pediatric surgery for resection, transection, and the creation of anastomoses. It is also used for transection and resection of liver substance, hepatic vasculature, biliary structures, and the pancreas.
The recall was initiated because the Duet TRS may have the potential to injure adjacent anatomical structures, which may result in life-threatening post-operative complications. The recall covers 433,528 units distributed worldwide. The source text indicates that all lot numbers are affected.
Healthcare providers and facilities that have used or possess these devices should stop using them immediately. Consumers and patients who have had surgery involving this specific device should contact their healthcare provider for further guidance. The recalling firm is Covidien LP.
The recalled product
- Product
- Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Product Code: DUET4535. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surger
- Manufacturer
- Covidien LP
- Affected units
- 433,528
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot numbers
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 8 recalled by Covidien LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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