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A recall has been issued for Medtronic Shiley Neonatal and Pediatric Tracheostomy Tubes. Medtronic received reports that tracheostomy patients whose tubes were switched from a previous Shiley tracheostomy tubes to the newer model tubes experienced airway obstruction because of potential differences in the angle of the newer tubes from that of the older tubes. Since each patient has their own distinct anatomy and their 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 switching patients from the older tubes to the newer tubes. If left untreated, these events may result in permanent injury. Twelve reports of serious injuries have been reported to the FDA; no deaths have been reported. Health care providers and facilities should immediately stop using the recalled tubes and use alternatives instead.
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