FDA Recalls Covidien Duet TRS Stapler Units Due to Injury Risk
The FDA is recalling 135,712 units of the Covidien Duet TRS 60 4.8 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 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 Articulating Single Use Loading Unit (Product Code: DUET6048A). The recall involves 135,712 units distributed worldwide. The 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.
The recall was initiated because the Duet TRS device has the potential to injure adjacent anatomical structures. This risk may result in life-threatening post-operative complications. The source text does not specify a particular lot number, stating that the recall applies to all lot numbers.
Healthcare providers and facilities should stop using the affected devices immediately. Consumers and patients should contact their healthcare provider if they have recently undergone surgery using this specific stapler unit to discuss potential risks and necessary follow-up care.
The recalled product
- Product
- Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6048A. 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
- 135,712
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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