Medical Tubing and Extrusion

Medical tubing and extrusion technologies

FDA warns of risk from Medtronic silicone-based EMG endotracheal tubes

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medtronic-large-updatedThe FDA is evaluating the risk of Medtronic (NYSE:MDT) silicone-based electromyogram (EMG) endotracheal tubes following reports of deaths and serious adverse events.

The FDA issued the warning last week in a letter to healthcare providers concerning the Medtronic NIM Standard Reinforced EMG Endotracheal Tubes and Medtronic NIM Contact Reinforced EMG Endotracheal Tubes. They are the only silicone-based EMG tubes currently sold in the U.S.

The FDA said there is a risk of airway obstruction, ventilation failure, oxygen deprivation and death from the 510(k)-cleared tubes, which provide an airway during surgery and use electrodes to monitor nerves to the laryngeal musculature when connected to an EMG monitor.

Get the full story at our sister site, Medical Design & Outsourcing.

About Jim Hammerand

Jim Hammerand is the managing editor of Medical Design & Outsourcing. He has more than 15 years of professional journalism experience spanning newspapers, magazines, websites and broadcast news. For nearly a decade, he reported and edited business news for American City Business Journals as a reporter and digital editor at the Minneapolis/St. Paul Business Journal and then managing editor of the Puget Sound Business Journal in Seattle. He holds a bachelor’s degree in journalism from the University of Minnesota. He is based near Seattle in Edmonds, Washington, where he and his family live. Connect with him on LinkedIn or by email at jimhammerand@wtwhmedia.com.