MedWatch – The FDA Safety Information and Adverse Event Reporting Program

Update: Recommendations for Certain Medtronic Electromyogram Endotracheal Tubes and Risk of Airway Obstruction – Letter to Health Care Providers

Today, the U.S. Food and Drug Administration (FDA) is issuing an updated Letter to Health Care Providers to ensure health care providers in the operating room setting are aware of the voluntary recall initiated by Medtronic for the risk of airway obstruction with the NIM CONTACT Reinforced EMG Endotracheal Tube and NIM Standard Reinforced EMG Endotracheal Tube. Medtronic issued a customer letter and is working to update and provide new device instructions for use to customers. Additionally, the FDA issued a notification of this Class I recall, the most serious type of recall.

The updated Letter to Health Care Providers includes important information for these devices, including:

• Recommendations for health care providers in the operating room setting.
• Background information about the issue.
• 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).