FDA Recalls Covidien Duet TRS Surgical Staplers Due to Injury Risk
The FDA is recalling 94,301 units of the Covidien Duet TRS 45 3.5 mm Universal Articulating 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 severity 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 Articulating Single Use Loading Unit (Product Code: DUET4535A). The recall covers 94,301 units distributed worldwide. The device is a single-use loading unit tissue reinforcement stapler used in abdominal, gynecologic, and pediatric surgery for resection, transection, and the creation of anastomoses.
The recall was initiated because the Duet TRS device has the potential to injure adjacent anatomical structures. This defect may result in life-threatening post-operative complications. The recall includes all lot numbers of the affected product.
Healthcare providers and facilities that have used or possess these devices should stop using them immediately. Patients who have had surgery using this specific device should contact their healthcare provider to discuss their medical history and any potential risks.
The recalled product
- 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 su
- Manufacturer
- Covidien LP
- Affected units
- 94,301
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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