Covidien (NYSE:COV) recalled certain lots of its cuffed Shiley tracheostomy tubes after receiving reports that the devices malfunctioned during patient ventilation.
The recall received Class I status from the FDA, designating a device issue "in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death."
The troubled Shiley tubes, manufactured by Covidien subsidiary Nellcor Puritan Bennett, are placed through a patient’s windpipe during a surgical procedure in order to create an airway and provide a path for removing liquid from the trachea and lungs, according to the FDA notice.
Covidien launched a global recall mid-July, asking customers to return affected lots of the Shiley reusable cannula, cuffed size 8 tracheostomy tubes, which were distributed between October 2009 and June 2012, according to a company press release.
"This voluntary recall was initiated following an analysis by Covidien of customer reports of volume leakage and/or disconnection between the inner and outer cannula involving these specific tracheostomy tubes," according to the company report. "These events were typically observed during mechanical ventilation and represent a small fraction of the tubes distributed. Volume leakage and/or disconnection could impact ventilation."
Covidien has seen a few recalls in the past few months. Last month the Natick, Mass.-based medical device maker issued a renewed U.K. warning on potential battery defects in certain mobile ventilators used primarily by patients in their homes.
Earlier in July the FDA issued a safety alert after receiving reports of more than 100 adverse events, including 9 patient deaths, that may have been caused by Onyx brain blood vessel plugs made by Covidien subsidiary ev3 Inc.
In June the FDA asked Covidien to defend its management of the recall of its Duet TRS surgical staples, which were pulled off the shelves after they were implicated in 13 patients injuries and 3 deaths.
COV shares were down a modest 0.3% to $57.22 as of about 1:30 p.m. today.
