Medtronic Recalls 70,000 Tracheostomy Tubes Following Reports of Breathing TroublesJun 26, 2015
Some 70,000 tracheostomy tubes for infants and children are being recalled by Medtronic PLC following injury reports. According to Star Tribune, reports indicate that some patients had trouble breathing while using the Covidien Shiley tube. The disposable tubes are used to create an airway or remove secretions from the lungs after an incision is made in the trachea.
In 2012, the tube was modified to have a wider angle. Star Tribune reports that the U.S. Food and Drug Administration (FDA) received hundreds of adverse event reports involving the device since then. Medtronic said in statement that the issues appeared to be resolved upon switching back to the older model. The Minnesota-based company began alerting hospitals on May 8th to stop using the devices. A total of eight Shiley tubes will be removed from use. A Medtronic spokesperson said the company had an adequate amount of older models to replace them.
In many of the injury reports submitted to the FDA, the problem is described as losing air pressure unexpectedly. Star Tribune reports that one patient had to be connected to a ventilator on March 9 following an unexpected deflation. This incident, however, was not classified as a serious injury. Medtronic said the global recall was prompted by 12 serious patient injuries. The tube is manufactured in Mexico and has been sold in 12 countries, including the United States and Canada.