Do Not Use Medtronic NIM Standard and Contact EMG Endotracheal Tubes - Letter to Health Care Providers
Update November 22, 2024
The FDA classified this recall as a Class I recall, the most serious type of recall. More information is available in the following device recall database entries:
July 9, 2024
The U.S. Food and Drug Administration (FDA) is alerting health care providers and facilities to stop using NIM Contact EMG Reinforced Endotracheal Tubes and NIM (Standard) EMG Reinforced Endotracheal Tubes by Medtronic. These neural integrity monitor (NIM) electromyogram (EMG) endotracheal tubes are used during surgery to provide an airway for patient ventilation and to monitor EMG activity and the nerve integrity of the thyroarytenoid muscle of the larynx.
On July 9, 2024, Medtronic issued an Urgent Medical Device Recall notice for removal of all NIM Standard and Contact EMG endotracheal tubes from inventory due to issues with tube blockage.
The FDA is issuing this letter to help ensure you are aware of the manufacturer's recall notice and the recommended actions.
Recommendations
- Review the Urgent Medical Device Recall notice from Medtronic for removal from inventory of all NIM Contact EMG Reinforced Endotracheal Tubes and NIM (Standard) EMG Reinforced Endotracheal Tubes. This notice includes model numbers and Unique Device Identifier (UDI) information.
- Do not use NIM Contact EMG Reinforced Endotracheal Tubes and NIM (Standard) EMG Reinforced Endotracheal Tubes.
- Return affected products in your inventory to Medtronic.
- Report any issues with these devices to the FDA.
Background
Medtronic has received complaints indicating potential health hazards from degraded or complete loss of functionality of NIM Standard and Contact EMG Endotracheal Tubes with all models and lots. The potential risks associated with use of these devices can include airway obstruction, unintended extubation, bronchospasm, hypoventilation, low oxygen saturation, hypoxia, respiratory distress, abnormal blood gas measurements, cyanosis, apnea, respiratory arrest, cardiac arrest, brain injury, and death.
FDA Actions
The FDA will continue to work with Medtronic to help ensure that health care providers and facilities are notified to stop using the recalled products.
The FDA will continue to keep health care providers and the public informed if significant new information becomes available.
Previous FDA Communications
| Date | Event |
|---|---|
| February 21, 2024 | The FDA provided an update for Medtronic’s follow-up customer letter with updated instructions for use and new training material including information on what to do when airway obstruction has occurred. |
| September 16, 2022 | The FDA provided an update to ensure that health care providers were aware of the voluntary recall (correction) initiated by Medtronic for the risk of airway obstruction with the NIM Contact EMG Reinforced Endotracheal Tube and NIM (Standard) EMG Reinforced Endotracheal Tube. |
| September 12, 2022 | The FDA issued a Class I recall notice for the Medtronic NIM Contact EMG Reinforced Endotracheal Tube and the NIM (Standard) EMG Reinforced Endotracheal Tube for risk of airway obstruction. |
| April 27, 2022 | The FDA informed health care providers that the FDA was evaluating the potential risk of airway obstruction when using Medtronic NIM (Standard) EMG Reinforced Endotracheal Tubes and NIM Contact EMG Reinforced Endotracheal Tubes. |
Unique Device Identifier (UDI)
The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use.
- For detailed information about the UDIs for this recall, see the Medtronic Urgent Medical Device Recall notice.
- For more information on UDI, please visit Unique Device Identification Systems (UDI Systems).
Reporting Problems to the FDA
- You may submit voluntary reports through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
- Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
By promptly reporting adverse events, you can help the FDA identify and better understand the risks associated with medical devices.
Contact Information
If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).