Medtronic's Shiley and Pediatric Tracheostomy Tubes Recalled Because of Patient Breathing DifficultiesJul 31, 2015
Reports of breathing difficulties in patients switched from older models of tracheostomy tubes to newer models prompted Medtronic Inc. to initiate the recall of 8,192 Shiley Neonatal Pediatric and Tracheostomy Tubes (cuffless and tubes with TaperGuard cuff) in May.
Tracheostomy—a surgical procedure—creates an opening through the neck into the windpipe (trachea). A tube is then inserted to provide an airway and to remove secretions from the lungs. The recalled Shiley tracheostomy tubes are used in infants and children. The Food and Drug Administration (FDA) said there were 12 reports of serious injuries associated with the Shiley tubes, but, to date, no deaths have been reported.
In its recall announcement, the FDA said there were reports of breathing difficulties in tracheostomy patients who were switched from a previous Shiley tracheostomy tube to the newer model. The infants and children experienced airway obstruction because of differences in the angle of the newer tubes. The FDA explains that each patient has a distinct anatomy and the trachea may become accustomed to the particular tube that is used. Changing the tube, particularly to one with a different angle, may cause airway obstruction.
Airway obstruction may cause acute lack of oxygen in the blood (oxygen desaturation), low amounts of oxygen reaching body tissue (hypoxia), and excessive carbon dioxide in the patient’s blood (hypercapnia), according to the FDA. Breathing difficulties associated with these issues were observed immediately after patients were switched from the older tubes to the newer ones. If left untreated, the obstruction may result in permanent injury.
The recall covers more than 8,000 tracheostomy tubes manufactured and distributed in the U.S. from May 2, 2013 to April 27, 2015. A full list of the affected models and lot numbers can be found on the FDA web site. Any health care professional or caregiver who is unable to determine if the tubes they have are among the affected ones should treat those products as if they are among the recalled lots and stop using them. The lot number appears on the product labeling and the first two digits of the number represent the year of manufacture, e.g., 12 is for 2012, 13 is for 2013 and so on.
The FDA has deemed this a Class I recall, the most serious recall type. Class I is reserved for situations where there is a reasonable probability that use of the device will cause serious adverse health consequences or death.
The FDA directs 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 Medtronic at ShileyFCA@Covidien.com or by phone at 1-800.635.5267 option 1, option 1, and again option 1.
The agency encourages health care professionals to report adverse reactions or quality problems the Shiley tracheostomy tubes to the MedWatch Safety Information and Adverse Event Reporting program, www.fda.gov/MedWatch/report. Reports may be made online, by mail, or by fax.