Covidien Duet TRS Problems Leads to FDA Warning

A federal health regulators have sent a warning letter to Covidien LP, accusing the medical device manufacturer of failing to properly address reports of serious injury and death with the Covidien Duet Tissue Reinforcement System (TRS) Reload, which is a device used in thoracic surgery. 

According to a warning letter posted by the FDA this week, a number of injuries and deaths have been linked to the device and Covidien failed to implement a corrective and preventive action investigation (CAPA) promptly, and failed to take appropriate steps to report and document the complaints.

A Covidien Duet TRS recall was announced earlier this year, after the manufacturer received reports of at least three deaths and 13 serious injuries among patients who had thoracic surgery involving the device.

An example of the company dropping the ball in investigating problems, as documented in the letter, was a case of problems in Japan. The letter detailed how the firm failed document those cases that date back as far as 2009. When investigators requested documentation about the complaints, Covidien presented interoffice emails. When asked why that was the only documentation they had, officials said the documentation was not kept in an “organized state in the normal course of business”.

The FDA warned the company that failing to correct the violations could result in further regulatory action by the FDA, including seizure of products, injunctions or civil fines.

The recall of the Covidien Duet TRS was the second major medical device recall by the company this year. A Covidien Roticulator stapler recall was issued in May, affecting 58 lots of staplers used to close wounds and surgical incisions. That recall was issued because the sterility barrier for the surgical staplers was compromised, increasing the risk of hospital acquired infection for patients undergoing surgery.