FDA Issues “Do Not Use” Warning for Recalled Medtronic NIM Endotracheal Tubes

At least 77 complaints have been received involving problems with recalled Medtronic NIM endotracheal tubes, including reports of the devices losing functionality and degrading.

Federal regulators are warning healthcare providers not to use Medtronic endotracheal tubes, which provide oxygen to patients during surgery, because they can become blocked, causing serious side effects, including death.

On July 9, the U.S. Food and Drug Administration (FDA) issued a letter to healthcare providers that includes a “Do Not Use” warning for Medtronic NIM Standard EMG and NIM Contact EMG endotracheal tubes. The same day the letter was issued, Medtronic issued an endotracheal tube recall (PDF).

The endotracheal tubes are used with neural integrity monitors (NIMs) during surgery to provide an airway for patient ventilation. The NIM monitors EMG activity and the nerve integrity of the thyroarytenoid muscle of the larynx. They are crucial in providing an air supply to patients during surgery. Malfunctions to the airway tubes can cause serious harm to patients.

According to the FDA, a total of 77 complaints have been reported involving problems with the functionality of the tubes, which can have serious consequences for patients. Many of the complaints warn of degraded tubes or complete loss of function on all models and all lots of the endotracheal tubes.

Many of the risks patients experienced when using the recalled endotracheal tubes include airway obstruction, respiratory arrest, cardiac arrest, brain injury, bronchospasm, hypoventilation, low oxygen saturation, unintended extubation, hypoxia, respiratory distress, abnormal blood gas measurements, cyanosis, apnea, and even death.

So far, no deaths have been reported in connection with the recalled endotracheal tubes.

Medtronic Endotracheal Tube Recall

The recall involves Medtronic 6 mm, 7 mm, and 8 mm NIM EMG and Contact EMG endotracheal tubes model numbers 8229306, 8229307, 8229308, 8229507, 8229508, 8229307J, 8229306J, and 8229308J.

The FDA warned healthcare providers not to use the affected endotracheal tubes and recommends healthcare providers return any affected products still in inventory to Medtronic.

Any side effects or adverse events experienced while using the devices should be reported to the FDA’s MedWatch Adverse Event Reporting Program.