FDA Pens Letter Alerting Providers to Medtronic Endotracheal Tube Recalls

The FDA has penned a letter to health care providers to ensure that they are aware of recalls of NIM Contact EMG Reinforced Endotracheal Tubes and NIM (Standard) EMG Reinforced Endotracheal Tubes by Medtronic.

These 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.” 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.”

The FDA recommends that providers review the Urgent Medical Device Recall notice from Medtronic, and to return and not use the tubes.