Update: Recommendations for Certain Medtronic Electromyogram Endotracheal Tubes and Risk of Airway Obstruction

September 16, 2022

The U.S. Food and Drug Administration (FDA) is updating the Letter to Health Care Providers issued on April 27, 2022, 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. If the tube obstructs and does not ventilate properly, patients may suffer oxygen deprivation, brain damage, or death. 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 FDA will continue to monitor reports of airway obstruction and ventilation failure with these devices.

The FDA recommends health care providers in the operating room setting, including anesthesiologists, nurse anesthetists, and surgeons:

Electromyogram (EMG) endotracheal tubes are used during surgery to provide an airway for patient ventilation and allow for intraoperative monitoring of EMG activity and the nerve integrity of the thyroarytenoid muscle of the larynx. These devices are 510(k) cleared and are made from either PVC or silicone elastomer. In the U.S., the currently marketed silicone-based EMG tubes are the Medtronic NIM CONTACT Reinforced EMG Endotracheal Tubes and NIM Standard Reinforced EMG Endotracheal Tubes.

The FDA continues to work with the manufacturer to further evaluate the issue and identify potential contributing factors and mitigation strategies. The FDA will continue to monitor reports of adverse events related to the issue.

The FDA will keep health care providers and the public informed if significant, new information or recommendations become available.

The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with Medtronic NIM CONTACT Reinforced EMG Endotracheal Tubes and NIM Standard Reinforced EMG Endotracheal Tubes. Prompt reporting can help the FDA identify and better understand the risks associated with medical devices and improve patient safety.

If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).

09/16/2022