Recall of Covidien Infant and Child Tracheostomy Tubes Because of Breathing DifficultiesJun 26, 2015
On May 8, 2015 Medtronic began notifying hospitals and distributors that lots of its Covidien Shiley tracheostomy tubes for infants and children manufactured after November 29, 2012 were formed with a wider-angle bend than standard models. Medtronic has recalled 70,000 tracheostomy tubes following reports that some patients have had difficulty breathing while using them.
Hundreds of adverse events involving the Covidien Shiley tube have been reported to the Food and Drug Administration (FDA) and foreign regulators since the device was altered to give it a wider angle.
Medtronic said in a statement that switching back to the tube design that predates the change seemed to address the issue, and the company said it has sufficient supplies of the earlier model tubes to meet demand. Eight specific types of Shiley tubes are being removed from use; a complete list of the recalled tubes can be found on the FDA web site.
A tracheostomy tube is inserted into the trachea to create an airway or to remove secretions from the lungs. The recalled tubes are used both in hospitals and for home care. The tubes are changed regularly and patients who are not experiencing discomfort may have the tube model switched at their next regular tube change.
The FDA has received reports of unexpected loss of air pressure. In March, a patient had to be connected to a ventilator in a hospital intensive care unit after an unexpected deflation. Medtronic said there had been 12 serious patient injuries, including breathing difficulties that immediately affected oxygen levels, but no reports of permanent impairment.
The recalled tubes were manufactured in Mexico and were designed by Dublin-based Covidien, which was recently acquired by Medtronic, the StarTribune reports. The FDA website has a complete list of the recalled tubes. The FDA advises customers and distributors to discontinue use of the eight tube types, remove those tubes from inventory, and return them to the company as soon as possible. The recalled tracheostomy tubes were distributed in 14 countries, including the United States and Canada.
If the tracheostomy tubes are being used in home treatment, the primary care physician and the homecare provider must be notified to discontinue use of the affected tubes and return the tubes to Medtronic. The FDA said that if a care provider cannot determine whether the tubes are the recalled models, they should treat the tubes as if they are among the recalled lots, stop using them, and consult the company for clarification.
The FDA encourages anyone who experiences an adverse event with these tracheostomy tubes to report the event through the MedWatch Adverse Event Reporting program: www.fda.gov/medwatch/report.htm.
Hospitals, care providers, and distributors can contact Medtronic about the recall by email at HQTSWEB@COVIDIEN.COM, or by phone at 800-635-5267 option 1, option 1, and again option 1. The call center operates from 6:00am to 4:00pm Pacific time, Monday through Friday, but callers can leave a message after hours.