Infants and children switched from older to newer models of Medtronic Shiley Neonatal and Pediatric Tracheostomy tubes developed breathing difficulties and this prompted Medtronic Inc. to recall 8,192 of the tubes in May.
In its recall announcement, the Food and Drug Administration (FDA) said there had been 12 reports of serious injuries associated with the Shiley tubes, but no deaths have been reported to date.
Tracheostomy is a surgical procedure to create an opening through the neck into the windpipe (trachea). A tube is inserted in the opening to provide an airway for the patient and to remove secretions from the lungs. The recalled Shiley tracheostomy tubes are used in infants and children. The breathing difficulties occurred in patients who were switched from a previous Shiley tracheostomy tube model to a newer model. The infants and children experienced airway obstruction because of differences in the angle of the newer tubes. Because each patient has a distinct anatomy, trachea may become accustomed to a particular tube and if the tube is changed, particularly to a model with a different angle, airway obstruction may occur.
Airway obstruction is a serious concern. The patient may experience acute lack of oxygen in the blood (oxygen desaturation), low amounts of oxygen reaching body tissue (hypoxia), and excessive carbon dioxide in the blood (hypercapnia), according to the FDA. Such issues were observed immediately after patients were switched from the older tubes to the newer ones. If the situation is not corrected, it may result in permanent injury.
More than 8,000 tracheostomy tubes manufactured and distributed in the U.S. from May 2, 2013 to April 27, 2015 are included in the recall. A full list of the affected models and their lot numbers can be found on the FDA web site. If a health care facility or is unable to determine if the tubes they have on hand are among those affected by the recall, they should treat the tubes as if they are among the recalled lots and stop using them. The lot number can be found on the product labeling. The first two digits of the number indicate the year of manufacture: 12 for 2012, 13 for 2013 and so on.
This recall is designated Class I, the FDA’s most serious device recall category. A Class I recall is applied to situations where there is a reasonable probability that use of the device will cause serious adverse health consequences or death.
The FDA has directed health care providers and facilities to stop using the recalled tubes immediately and contact Shiley about returning them. Questions about the return process may be directed to ShileyFCA@Covidien.com or by phone at 1-800.635.5267 option 1, option 1, and again option 1.
Health care professionals and facilities are encouraged to report adverse reactions or quality problems with the Shiley tracheostomy tubes through the FDA’s MedWatch Safety Information and Adverse Event Reporting program, www.fda.gov/MedWatch/report. Such reports can be made online, by mail, or by fax.