Medtronic Recalls Tracheostomy Tubes Due to Dislodgement Risk

Medtronic has recalled specific Shiley adult tracheostomy tubes after reports of the flange detaching, posing a risk of the tube shifting or dislodging. This could block the airway, leading to serious complications like respiratory failure, injury, infection, or death. The FDA classified it as a Class I recall, the most serious type.

In a February 26 notice, Medtronic advised healthcare providers to stop using and return affected products. About 780 units were distributed across multiple countries, including France, Germany, South Africa, Spain, and Taiwan.

The FDA recommended replacing affected devices in current use. This follows a larger 2023 recall of nearly 600,000 units due to manufacturing issues.

Medtronic’s tracheostomy tubes are used to assist breathing or during neck surgery, where secure placement is critical.

10-06-2025