The U.K.’s Medicines & Healthcare products Regulatory Agency issued a new alert on an ongoing recall of Covidien’s (NYSE:COV) cuffed Shiley tracheostomy tubes, urging healthcare providers to identify and quarantine the devices as soon as possible.
The alert follows Covidien’s decision over the summer to recall certain lots of the breathing tubes after receiving reports that the devices malfunctioned during patient ventilation.
That 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 MHRA issues its own update this week on the grounds that "the MHRA cannot be confident that the recall action has been effective and that users have received and acted on the information," according to the alert.
Covidien launched a global recall mid-July, asking customers to return affected lots of the Shiley devices, which were distributed between October 2009 and June 2012.
"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 its share of recalls in recent months. In July 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.
Just weeks earlier the FDA had 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 slipped slightly today, trading 0.4% lower at $59.34 as of about 2 p.m.
