Medtech giant Medtronic has issued a worldwide voluntary recall of a shiley tracheostomy tube.
A shiley tracheostomy tube is put through a patient's trachea (windpipe) during a tracheostomy procedure to help provide an airway and facilitate the ability to breathe.
According to the FDA, “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.”
Medtronic says that customers and distributors, who have provided the recalled Shiley tracheostomy tubes to a homecare provider or patient should notify the primary care physician and the homecare provider that these products should be discontinued from use and returned.
If one of the recalled products is currently in use in a homecare patient, and the patient is not experiencing any discomfort, breathing difficulties or any other issues related to the tube, the group recommends that the patient's physician evaluate the continued use. If the physician advises leaving the tracheostomy tube in place, the tube must be replaced with an alternate device at the next tube exchange.