Medtronic announced they are voluntarily recalling eight types of Covidien Shiley tracheostomy tubes, over 70,000 products, in the wake of reports that patients had difficulty breathing with the tubes due to an unexpected loss of air pressure.
Although the global recall was issued this year, 2015, the FDA has reported that people have been complaining of the adverse effects dating back to a design change in 2012. During this period, the tubes began to be manufactured with wider-angle bend than standard models. The recalled tubes were used in hospitals and other healthcare facilities globally to treat children and babies during tracheostomy procedures.
A tracheostomy is when the physician makes an incision into the patient’s windpipe, trachea, and inserts a tube through this opening to facilitate breathing.
Medtronic began alerting hospitals in early May about the issue, and a company spokesperson assured care providers that they had enough supply of its pre-2012 tubes to meet demand for the recalled tubes. Although there have been no reports of permanent impairment to date at least 12 minors suffered “serious injury” and immediate decrease in oxygen levels following the use of the device.
Because the tubes are disposable if the individual is not suffering from problematic breathing as a result of the product physicians may elect to remove recalled tube during the next scheduled tube exchange.
Our attorneys have won millions for individuals harmed by recalled medical devices. If you have any questions call toll-free 1-888-377-8900 or fill out a form for a FREE CONSULTATION