Medtronic PLC is voluntarily recalling 70,000 tracheostomy tubes for children and babies following reports that some patients had difficulty breathing while using them.
Hundreds of adverse events involving the Covidien Shiley tube have been reported to regulators since 2012, when the device was altered to give it a wider angle. Switching back to models predating the design change seemed to address the young patients' issues, according to a statement Tuesday from Minnesota-run Medtronic.
A spokesman for Medtronic said the company has enough supply of its pre-2012 tubes on hand to meet demand for the eight specific types of Shiley tubes that are being removed from use. The company started notifying hospitals on May 8 that they should stop using the tubes, including for patients who may be on home care.
A tracheostomy tube is used after a physician makes an incision in a patient's trachea to create an airway or to remove secretions from the lungs. The tubes are disposable, so some patients who are not experiencing discomfort may wait to switch during their next regular tube change.
Many of the adverse events reported to the Food and Drug Administration regarding the Shiley tube describe it as unexpectedly losing air pressure. 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.
In its announcement Tuesday, Medtronic said there had been 12 serious patient injuries that led to the global recall, including breathing difficulties that immediately affected oxygen levels.
Company spokesman John Jordan also noted that "discomfort" is considered a serious patient injury in cases like these. There have been no reports of permanent impairment following use of the device.
The Mexican-manufactured tubes have been sold in 14 countries, including the U.S. and Canada.
The tube was designed by Dublin-based Covidien. Medtronic, the world's largest medical device company, acquired hospital supplier Covidien in late January in a $49.9 billion acquisition that located the combined company's headquarters in Ireland but kept many executives' offices in Minnesota. Most of the Covidien businesses were rolled into a stand-alone business group with about $9.5 billion in revenue.
Joe Carlson • 612-673-4779
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