FDA sticks Class I tag on Covidien recall

Covidien recalled certain models of its Shiley tracheostomy devices--courtesy of Covidien

In July, Covidien ($COV) launched a voluntary recall of its Shiley tracheostomy devices. Now the FDA has slapped a Class I tag on the affair, warning that the leaky cannulae could result in injury or death.

On July 18, Covidien notified patients and physicians that certain lots of the Shiley devices--used to help patients breathe during tracheostomy procedures--were prone to leaking or disconnecting during use, which could lead to interruptions in ventilation and possible danger for users.

The recall applies to the 8LPC and 8FEN models of the device, manufactured and distributed between October 2009 and June 2012, and Covidien said it is providing replacement tubes to affected patients. The FDA is advising customers to return all unused devices to Covidien and, if a patient has already been outfitted with one, to replace it as soon as possible.

The Shiley recall is Covidien's second in the past few months, as the company discovered a packaging issue in some of its Roticulator staplers back in May, recalling 5 models over sterility worries. In July, Covidien warned U.K. regulators that the batteries in some of its at-home ventilators could fail, but the company did not issue a recall of the devices.

- read the FDA recall notice