The FDA is lending its federal megaphone to an urgent medical device recall from Medtronic. The agency alerted healthcare providers to stop using certain models of the company’s endotracheal tubes, following reports that their airflow could become blocked.
Medtronic’s recall, launched July 9, pulls all versions and lots of its NIM Standard and NIM Contact EMG reinforced endotracheal tubes from the market, and the company said it is canceling all existing orders. The tubes are designed to ventilate patients during surgery, in addition to monitoring the neural integrity of the muscles of the larynx throughout a procedure.
According to the company’s notice (PDF), Medtronic has received 77 complaints of malfunctions between March 2020 and May 2024—resulting in airway obstructions, unintended extubations, low oxygen saturation and respiratory distress, as well as reports of respiratory arrest, cardiac arrest, brain injury and death.
Medtronic previously issued a safety notice for the devices in April 2022—which included warnings against overinflating the tubes’ internal cuffs—while the FDA later handed down a Class I recall label that September, which spanned nearly 400,000 units distributed worldwide.
The company followed up with FDA-cleared labeling updates and additional provider notices in January of this year (PDF), alongside new anesthesia training efforts.
The FDA said it is publishing its own letter this week to ensure that providers are aware of the latest recall. The agency has not yet delivered a formal recall classification, but it reiterated the risks of severe injury or death.