Ireland-based medical device company Medtronic has issued a worldwide recall of certain lots of its Covidien Shiley neonatal and pediatric tracheostomy tubes. According to the U.S. Food and Drug Administration (FDA), Medtronic announced on May 8 that it had begun “notifying hospitals and distributors worldwide that affected lots of its Covidien Shiley(TM) tracheostomy tubes were formed with a wider-angle bend than standard models manufactured after November 29, 2012.”
The Shiley tracheostomy tube is used during tracheostomy procedures to relieve obstructed or impaired breathing. The device is inserted through an incision in the patient’s neck and fed down the throat to provide a clear airway. However, the wider-angle bend of the recalled Covidien Shiley tracheostomy tubes can result in breathing difficulty or discomfort for the patient. According to the FDA, Medtronic received reports of 12 serious patient injuries resulting from use of its Shiley tracheostomy tubes.
Medtronic has taken steps to prevent future shipments of the recalled tracheostomy tubes. The company has also notified health and consumer agencies around the world, requesting that all customers and distributors quarantine and discontinue use of the affected devices.
Drug companies and medical device manufacturers have a responsibility to ensure the safety of patients and consumers. The product liability lawyers at Lopez McHugh are experienced in dealing with cases involving defective or deceptively marketed devices. If you or someone you know was injured by a Covidien Shiley tracheostomy tube, contact Lopez McHugh right now for a free legal consultation. You may be entitled to compensation.