The tracheostomy tubes caused breathing troubles for some.
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.