Medtronic EMG Tube Airway Risk Evaluated

FDA says it is evaluating the potential risk of airway obstruction when using two Medtronic silicone-based electromyogram (EMG) endotracheal tubes. An agency letter to healthcare providers identifies the affected devices as the Medtronic NIM Standard Reinforced EMG Endotracheal Tube and the Medtronic NIM Contact Reinforced EMG Endotracheal Tube.

The letter says FDA has received reports describing serious adverse events and deaths for the devices after airway obstruction and ventilation failure.

“At this time,” the letter says, “the root cause and incidence of obstruction and ventilation failure with use of these devices is not known. However, information from medical device reports currently suggests that reported events of airway obstruction are more frequent for silicone-based EMG tubes compared to other tubes.”

The letter includes recommendations for healthcare providers in operating rooms including anesthesiologists, nurse anesthetists, and surgeons.