The FDA issued a notice instructing healthcare providers to stop using certain reinforced endotracheal tubes made by Medtronic (NYSE:MDT).
This warning extends to NIM Contact EMG reinforced endotracheal tubes and NIM (Standard) EMG reinforced endotracheal tubes. Medtronic offers the neural integrity monitor (NIM) electromyogram (EMG) tubes for surgical procedures. They provide an airway for patient ventilation and to monitor EMG activity and the nerve integrity of the thyroarytenoid muscle of the larynx.
Medtronic issued an urgent medical device recall notice for the tubes on July 9. It requested the removal of all NIM Standard and Contact EMG endotracheal tubes from inventory due to issues with tube blockage.
The medtech giant received complaints indicating potential health hazards from degraded or complete loss of functionality with all models and lots of the tubes. Potential risks 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.
Medtronic recommends that customers remove all inventory and refrain from using the tubes. Customers should return affected products to the company and report any issues with the devices to the FDA.
In 2022, the FDA issued a warning for the same Medtronic tubes following reports of deaths and serious adverse events. That warning highlighted a risk of airway obstruction, ventilation failure, oxygen deprivation and death. Medline had its own endotracheal tube recall last month as well.
The letter marks just the fourth instance this year in which the FDA issued a “letter to healthcare providers.”
