Medtronic Shiley Neonatal and Pediatric Tracheostomy Tubes May Cause Breathing Difficulties

In May 2015, Medtronic Inc. initiated the recall of 8,192 Shiley Neonatal Pediatric and Tracheostomy Tubes (Cuffless and tubes with TaperGuard Cuff) because of reports of breathing difficulties in patients who were switched from older tubes to these newer models.

According to the Food and Drug Administration (FDA) announcement of the recall, Medtronic had received reports of the breathing difficulties in tracheostomy patients who were switched from a previous Shiley tracheostomy tube to the newer model. They experienced airway obstruction because of differences in the angle of the newer tubes. The FDA explains that because each patient has a distinct anatomy and the trachea may have become accustomed to the inserted tube, 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). 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 situation may result in permanent injury, the FDA says.

Tracheostomy is a surgical procedure that creates an opening through the neck into the windpipe (trachea). The Shiley tracheostomy tubes are single-use devices placed into the surgical opening of the trachea to provide an airway and to remove secretions from the lungs. The recalled tubes were used in infants and children. The FDA has received 12 reports of serious injuries associated with the Shiley tubes, but, to date, no deaths have been reported.

The recalled tubes were manufactured and distributed in the U.S. from May 2, 2013 to April 27, 2015. A full list of the models and lot numbers can be found on the FDA web site. Customers who are unable to determine if the tubes they have on hand are within the affected lot numbers should treat those products as if they are among the recalled lots. Lot numbers appear on the product labeling and the number is structured with the first two digits representing the year of manufacturing, e.g., 12 is for 2012, 13 is for 2013 and so on.

This is Class I recall, the FDA’s most serious recall type, reserved for situations in where there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

The FDA advises health care providers and facilities to stop using the recalled tubes immediately and contact Shiley about returning them. Health care providers and facilities should immediately stop using the recalled tubes and use alternatives instead. For questions about the return process, please contact Medtronic at ShileyFCA@Covidien.com or by phone at 1-800.635.5267 option 1, option 1, and again option 1.

Health care professionals and patients may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting program, www.fda.gov/MedWatch/report. Reports may be made online, by mail, or by fax.

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