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Covidien Recalls Duet TRS For Thoracic Surgery, Device Linked To Three Deaths

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Covidien has issued a recall for its Duet TRS single use cartridges after the devices were linked to three deaths among patients undergoing thoracic surgery, the U.S. Food and Drug Administration (FDA) just announced. The Covidien Duet TRS is a product used in surgery in conjunction with a surgerical stapler.

The recall involves all production lots for the Duet TRS Universal Straight and Articulating Single Use Loading Units that involve use of this product family in the thoracic cavity. To date, Covidien has received 13 reports of serious injuries and 3 reports of patient deaths following the application of Duet TRS in the thoracic cavity.

“After receiving reports connecting the use of the Duet TRS with patient deaths after thoracic surgery, we have made the decision that the product should not be used in such procedures,” said Bryan Hanson, Covidien’s Group President, Surgical Solutions. “Accordingly, we are advising our customers that the Duet TRS should not be used in thoracic surgery,” Hanson added.

Because of these incidents, Covidien concluded that its Duet TRS has the potential to injure adjacent anatomical structures within the thorax cavity and that this potential may result in life-threatening, post-operative complications, including death. The product codes and descriptions for the recalled devices are:

• DUET4535
• DUET4535A
• DUET4548
• DUET4548A
• DUET6035
• DUET6035A
• DUET6048
• DUET6048A
• DUET TRS 45 3.5MM STRAIGHT SULU
• DUET TRS 45 3.5MM ARTICULATING SULU
• DUET TRS 45 4.8MM STRAIGHT SULU
• DUET TRS 45 4.8MM ARTICULATING SULU
• DUET TRS 60 3.5MM STRAIGHT SULU
• DUET TRS 60 3.5MM ARTICULATING SULU
• DUET TRS 60 4.8MM STRAIGHT SULU
• DUET TRS 60 4.8MM ARTICULATING SULU

Covidien announced that it is collaborating with the FDA and other worldwide regulatory authorities to modify instructions for use of the Duet TRS Universal Straight and Articulating Single Use Loading Units so that the device is contraindicated for use in adult and pediatric thoracic procedures. Covidien also put a hold on its Duet TRS inventory, worldwide, to allow for the products to be relabeled with the revised usage instructions. Covidien said it is providing information to its customers on alternative tissue reinforcement products that may be used in conjunction with Covidien endoscopic staplers for thoracic surgery.

The Duet TRS is a single-use loading unit with a fully integrated tissue reinforcement system to support staple lines in tissues that was released in 2009. To date, more than 500,000 units have been sold worldwide and Covidien believes about one-third of all global procedures involve use of the Duet TRS are for thoracic indications. The Duet TRS will continue to be used for other indications, including abdominal procedures.

Customers have been notified of this recall by letter on January 12, 2012 and have been advised that the device, intended for thoracic use, must be returned by contacting Covidien Customer Service by email at SDFeedback@Covidien.com or, toll-free, at 1.800.722.8772, option 1, to obtain a Return Goods Authorization prior to returning the affected units. Customers may choose to retain the product for uses other than thoracic.

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