Covidien Duet TRS Recall Issued After Injuries and Deaths

Reports of deaths and serious injuries due to surgical errors have led to a recall of the Covidien Duet TRS tissue stapling device, with about half a million of the devices sold worldwide. 

The FDA announced a Duet TRS Single Use Loading Unit recall on January 16, after the manufacturer, Covidien, received reports of at least three fatalities and 13 serious injuries among patients who had thoracic surgery where the device was used. The company has also contraindicated their use for thoracic surgery as well.

According to Covidien, the devices can injure organs and other vital body parts in the thorax adjacent to the location where it is being used. This can result in operating room mistakes and life-threatening complications.

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The recall affects Duet TRS Universal Straight and Articulating Single Use Loading Units in a variety of sizes and model numbers. Complete details about the affected units are provided in the recall notice.

Covidien estimates that of the 500,000 units sold worldwide since 2009, about one-third are used for thoracic surgery.

The Duet TRS will remain available for other uses, but the company has placed a hold on its inventory globally so that it can relabel them with new instructions that contraindicate the device for thoracic surgery. It will also provide information to customers on alternative tissue reinforcement products.

The company says it notified customers of the recall through letters sent out on January 12 and is asking all products intended for thoracic use to be returned. However, they can retain the devices if they decide to use them for uses other than thoracic surgery.

Customers with questions can contact Covidien customer service by calling (800) 722-8772 or by sending an e-mail to SDFeedback@Covidien.com.

Healthcare professionals and patients who experience problems with Duet TRS should contact the FDA’s MedWatch adverse event reporting program.

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