FDA Recalls Covidien Duet TRS Stapler Units Due to Injury Risk
The FDA is recalling 15,936 units of the Covidien Duet TRS 60 4.8 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 criterion for Severe (4) involving significant injury reports or high-risk structural defects.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit (Product Code: DUET6048). This medical device is a single-use loading unit tissue reinforcement stapler used in abdominal, gynecologic, and pediatric surgeries for resection, transection, and the creation of anastomoses. The recall covers 15,936 units distributed worldwide under all lot numbers.
The recall was initiated because the Duet TRS device has the potential to injure adjacent anatomical structures. According to the source text, this potential for injury may result in life-threatening post-operative complications. The device is manufactured by Covidien LP.
Healthcare providers and facilities that have used or possess these units should stop using them immediately. The source text does not provide specific instructions for disposal or return, but standard FDA recall procedures typically require contacting the manufacturer or the FDA for further guidance on how to handle the recalled devices.
The recalled product
- Product
- Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET6048. 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
- Manufacturer
- Covidien LP
- Affected units
- 15,936
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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