Dive Brief:
- The Food and Drug Administration told healthcare providers to stop using two endotracheal tubes made by Medtronic.
- On Tuesday, the agency said Medtronic has recalled nerve integrity monitoring (NIM) Standard and Contact EMG endotracheal tubes because of issues with blockages. Medtronic asked customers in a July letter to remove the devices from their inventories and return them to the company. Medtronic added that the products listed in the letter “are no longer available for distribution or sale.”
- Medtronic said it received 77 complaints between March 31, 2020, and May 20, 2024. The risk of airway obstruction when using the affected devices could result in brain injury and death.
Dive Insight:
Medtronic sent a safety notice about the devices in 2022. The notice, which the FDA categorized as a Class I recall, described complaints about airway obstruction and advised users to avoid overinflation of the product’s silicone cuff. At the time, Medtronic said three injuries and two deaths were associated with the issue between March 31, 2020, and March 31, 2022.
The issue resurfaced in January, when Medtronic sent a follow-up letter to customers to communicate information including updated instructions for use. Medtronic sought to mitigate the risks with actions including the deployment of training on using the tubes and labeling updates.
Now, Medtronic has told customers to immediately stop using the affected products. The company has stopped shipping the tubes to customers and is canceling all existing orders. The FDA amplified Medtronic’s message by publishing a notice telling healthcare providers not to use the tubes.
The removal of the devices follows years of reports about safety problems. A paper published in 2012 described a case and said the FDA recognized eight other reported events at that time. Another case report posted in 2022 hypothesized that the elasticity of the EMG cuff makes it more prone to airway obstruction.
Medtronic named endotracheal tubes as key products in its annual financial report, which the company published in June. The company included the tubes in a discussion of the importance of the “continued acceptance and growth in patient monitoring and airway management” for its medical surgical business.
Medline recalled more than 168,000 endotracheal tubes in May.