Medtronic’s Shiley Neonatal and Pediatric Tracheostomy Tubes have been recalled following reports of breathing issues when switching tubes to newer models. A tracheostomy is performed when the surgeon needs to create an opening in the patient’s trachea, or windpipe. The recalled tubes, which include the Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff, provide an airway and remove secretions from the lungs. These devices are used in children and infants.
According to a recall alert posted on the U.S. Food and Drug Administration’s (FDA’s) website, the tubes are being recalled because Medtronic received reports of patients who experienced airway obstruction when their previous Shiley tracheostomy tubes were switched to a newer model. This may have occurred because the newer tubes have differences in their angles, and “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.” according to the alert. [Read more…]