Medtronic reported two patient deaths and three injuries related to airway obstruction with some of its EMG endotracheal tubes. In total, the company has received 15 complaints between March 2020 and March 2022, according to an updated recall notice by the Food and Drug Administration.
Medtronic began a recall in April of its NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube, which are used to provide an airway and monitor laryngeal nerves during head and neck surgery. The company isn’t asking customers to return or replace the affected devices, but sent out instructions in a safety notice to prevent the device’s silicone cuff from obstructing a patient’s airway.
In an emailed statement, a Medtronic spokesman said the company is “evaluating the details and root cause regarding reports of rare instances of serious adverse events potentially related to certain EMG endotracheal tubes,” adding. “We expect to know more when we complete our evaluation.”
He said the company “believe[s] the NIM EMG tubes are safe when used according to the instructions for use,” and said customers are not being asked to return or replace products.
This article was updated to include comment from Medtronic.