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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Potential Risk of Airway Obstruction When Using Certain Electromyogram Endotracheal Tubes

Today, the U.S. Food and Drug Administration (FDA) is issuing a Letter to Health Care Providers to increase awareness about the potential risk of airway obstruction when using silicone-based electromyogram (EMG) endotracheal tubes (Medtronic NIM Standard Reinforced EMG Endotracheal Tube and Medtronic NIM Contact Reinforced EMG Endotracheal Tube). The FDA has received reports describing serious adverse events and deaths for these devices after airway obstruction and ventilation failure. At this time, the root cause and incidence rate of obstruction and ventilation failure with use of these devices is not known. 

The Letter to Health Care Providers includes important information about silicone-based EMG endotracheal tubes, including:

• Recommendations for health care personnel in the operating room setting.
• Actions the FDA is taking.
• Instructions for reporting problems with these devices.

Questions?

If you have questions about this Letter to Health Care Providers, contact the Division of Industry and Consumer Education (DICE).