FDA Recalls Covidien Duet TRS Stapler Units Due to Injury Risk
The FDA is recalling 4,867 units of the Covidien Duet TRS 45 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 criteria for a Severe (4) rating involving significant injury risk.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Covidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit (Product Code: DUET4548). The recall affects 4,867 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 may have the potential to injure adjacent anatomical structures. According to the FDA, this potential for injury may result in life-threatening post-operative complications. The recall covers all lot numbers of the affected product.
Healthcare facilities and consumers should stop using the affected units immediately. The recalling firm, Covidien LP, is responsible for managing the recall. Users should contact the manufacturer for instructions on how to return or dispose of the product.
The recalled product
- Product
- Covidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET4548. 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
- 4,867
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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