June 24, 2015 — Medtronic is recalling about 70,000 tracheostomy tubes for babies and children after at least a dozen patients were seriously injured.
The recall involves Covidien Shiley tracheostomy tubes, which are used to maintain an open airway after a doctor makes an incision in the patient’s throat (trachea) to facilitate breathing or remove lung
According to the Minneapolis Star-Tribune, hundreds of adverse events have been reported to the FDA, but Medtronic only classified a few as “serious.”
The problems appeared after November 2012, when the tubes were re-designed with a wider angle. Some patients had “breathing difficulties that impacted oxygen levels immediately upon tube placement” or serious discomfort when breathing.
One adverse event appeared to involve unexpected loss of air pressure, according to the Star-Tribune:
“On March 9, for example, an unexpected deflation required an unidentified patient to be connected to a ventilator in a hospital intensive care unit, although the report did not classify that as a serious injury.”
Medtronic warned hospitals and home-care providers about the problem on May 8. Fortunately, the company has enough pre-2012 tracheostomy tubes to meed demand. Since November 2012, the tubes have been distributed in 14 countries around the world.