Medtronic PLC has announced the voluntary recall of 70,000 tracheostomy tubes for children and babies 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 regulators since 2012, when the device was altered to give it a wider angle, the Minneapolis StarTribune reports.
In a statement this week, Medtronic said that switching back to tube model that predates the design change seemed to address the patient issues. Medtronic said it has a sufficient supply of pre-2012 tubes to meet demand for the eight types of Shiley tubes being removed from use. On May 8, the company began notifying hospitals to stop using the recalled tubes either for inpatients and for patients on home care.
A tracheostomy tube is used after a doctor makes an incision in the trachea to create an airway or to remove secretions from the lungs. The tubes are disposable, so the company says that for patients who are not experiencing discomfort, the tube type may be switched at the next regular tube change.
Many of the adverse events reported to the Food and Drug Administration cite the unexpected loss of air pressure, according to the StarTribune. In March, for example, an unexpected deflation required the patient to be connected to a ventilator in a hospital intensive care unit. Medtronic said there had been 12 serious patient injuries, including breathing difficulties that immediately affected oxygen levels, but no reports of permanent impairment following use of the tubes.
The tube, manufactured in Mexico, was designed by Dublin-based Covidien, which was recently acquired by Medtronic, the StarTribune reports.. A complete list of the recalled tubes can be found in the recall notice on the Food and Drug Administration web site. The FDA advises customers and distributors to discontinue use of the eight tube types, quarantine those tubes, and return the affected product to the company as soon as possible for credit.
If the recalled Shiley tracheostomy tubes have been supplied for home care, the patient’s primary care physician and the homecare provider must be notified that they should discontinue use of the affected tubes return the tubes to Medtronic. The FDA said that if a care provider cannot determine whether the tubes in use fall within the recall, they should treat the tubes as if they are among the recalled lots, should stop using them, and should contact the company.
Since November 29, 2012, the Shiley tracheostomy tubes were distributed to 14 countries: Australia, Belgium, Canada, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, Uruguay and the United States.
The FDA encourages those who experience an adverse event with these tracheostomy tubes product 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. Callers can leave a message after hours.