Medical device manufacturer Medtronic has reported two fatalities as a result of faults found in their EMG endotracheal tube. According to a recall notice posted by the United States Food and Drug Administration (FDA), the company has received 15 complaints between the period of March 2020 to March 2022.
In April, Medtronic recalled its Medtronic’s NIM CONTACT Reinforced EMG Endotracheal Tube and NIM Standard Reinforced EMG Endotracheal Tube devices. The devices are used to provide an airway to patient ventilation and monitor EMG activity and the nerve integrity of the thyroarytenoid muscle of the larynx. The recall was made by the device manufacturer after receiving complaints from its consumers regarding endotracheal tubes becoming obstructed while under use. When the tube does not ventilate successfully, patients who are using the device may experience oxygen deprivation, brain damage, or even death. Medtronic has reported that the faults in the devices have caused 15 complaints, three injuries, and two deaths.
On April 29, 2022, Medtroninc issued an Urgent Medical Device Correction that was distributed to users of these products, including anesthetic care providers. The manufacturer advised users that In order to reduce airway blockage, the silicone cuff of the product should not be overinflated. The letter also recommended healthcare providers to intubate the patient using best practices and medical training, to be cautious when altering the tune’s position as doing so might cause the inflated cuff to extend over the tube aperture and restrict the patient’s airway, and to deflate the cuff before manipulation or repositioning the tube or patient who is using the device. In the event that an airway obstruction does occur, Medtronic has advised operators to deflate the cuff and attempt to ventilate as soon as possible. If ventilation cannot be re-established, Extubate the endotracheal tube from the patient, Re-establish ventilation with bag valve mask or laryngeal mask airway, Reintubate with a new non-silicone endotracheal tube.
Medtronic has stated that they are analyzing the details and root causes of the reports and contend that the incidents of serious adverse events are extremely rare. The device manufacturer maintains that the NIM EMG tubes are safe for use when used according to the instructions for use.