The FDA is citing Covidien ($COV) for not taking prompt steps to correct potential problems with a tissue stapling system, three years after receiving initial complaints that the product caused deaths and serious injuries.
Regulators detail their concerns in the agency's June 14 warning letter to Covidien regarding company's Duet tissue reinforcement system reload, which is designed to support staple lines in tissues. The letter, addressed directly to president and CEO Jose Almeida, faults the company for not pursuing any fixes until January of 2012, even though it had received "numerous complaint, adverse event and serious adverse event information" regarding the product's use for abdominal indications since May of 2009.
FDA officials also hit the company for not documenting investigations into any deaths and serious injuries from the product after a safety alert was issued in Japan in March of 2011. The letter notes that the company's only documentation into the matter was interoffice emails regarding two trips to Japan by one of Covidien's medical officers.
Covidien could not be reached before deadline. But Duet TRS has caused problems before. The company disclosed in January it was conducting a voluntary recall of all production lots for the Duet TRS regarding its use in the thoracic cavity after reports of 13 serious injuries and three deaths. The product has been around since 2009 and Covidien had sold more than 500,000 units globally up until that point. At the time of the announcement, the company said it would be working with the FDA and other regulators to modify instructions for use for thoracic procedures, but that the device would still be used for abdominal procedures.
Covidien has 15 days from the warning letter date to respond and spell out correction actions.
- read the warning letter