Medtronic is recalling tracheostomy tubes for neonatal and pediatric patients after 12 serious patient injury reports. The tubes, used during tracheostomy procedures to help provide an airway and facilitate the ability to breathe, were formed with a wider-angle bend than standard models, which have caused complications in patients including breathing difficulties that impacted oxygen levels or discomfort.
The affected devices include eight product lines of Medtronic Covidien Shiley tracheostomy tubes manufactured after Nov. 29, 2012. Medtronic has informed hospitals and distributors worldwide of the recall and instructed them to notify the primary care physician and the homecare provider that the products should be discontinued from use and returned.
If one of the recalled products is currently in use in a patient and the patient is not experiencing any discomfort, breathing difficulties or any other issues related to the tube, it is recommended 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 alternative device at the next tube exchange.
Any side effects related to this recall should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.