Medline SubG Endotracheal Tube Recall: Inflation Problem Presents Health Risks

Failure of the recalled SubG Endotracheal Tubes can lead to respiratory distress, severe internal damage and the need for revision surgery.

Dozens of lots of Medline SubG Endotracheal Tubes have been recalled because they can become detached or torn, resulting in serious health and safety risks for patients, including the need to have the implants removed and replaced.

The U.S. Food and Drug Administration (FDA) announced the Medline SubG Endotracheal Tube recall on May 31, after it was discovered that the tubes detaching or tearing can result in moisture buildup, loss of pressure, and an inability to inflate. This could lead to severe health consequences, such as cardiac arrest, bleeding and organ damage.

The Medline SubG Endotracheal Tube is a medical implant placed between the vocal cords through the trachea, creating a seal and reliable cuff pressure. It provides oxygen and inhaled gases to the lungs, and can even protect them from contamination.

The risk of the tubes tearing and detaching creates an increased likelihood of a patient needing re-intubation. It could also cause delays in medical procedures or treatment, and respiratory distress due to loss of ventilation. There is also a risk of uncontrolled loss of airway gases and potential partial or total airway obstruction and choking if the device breaks apart during use.

These issues can lead to inefficient or failed ventilation and oxygenation, low blood oxygen levels (hypoxemia), retention of carbon dioxide, increased blood acidity (acidemia), reduced blood flow to organs (organ ischemia), cardiorespiratory arrest, regurgitation and aspiration of stomach contents, ventilator-associated pneumonia, slow heart rate (bradycardia), cardiac arrest, bleeding, and tissue and organ damage.

To date, there have been no serious health consequences reported in connection to this recall. The FDA and manufacturers advise customers using the SubG Endotracheal Tube with Subglottic Suction to discontinue their use and dispose of the devices. They are not to be returned to Medline.

Medline SubG Endotracheal Tube Recall

The recalled SubG Endotracheal Tubes with Subglottic Suction were manufactured between March 1, 2021, and January 1, 2024. They were distributed from March 1, 2021, to February 20, 2024 within the United States, El Salvador and United Arab Emirates. The manufacturer indicates it will notify distributors and customers by email or first class mail and is arranging credit for all recalled devices.

This recall includes six models of SubG Endotracheal Tubes with Subglottic Suction and 10 kits that contain the devices. All recalled devices can be identified by their product labeling, which will indicate the name of the device and product number and can be found in the recall notice. .

Consumers with questions about this recall can contact Medline Industries, LP by phone at 866-359-1704 or via email at recalls@medline.com, Monday through Friday, from 8am to 5pm CST. Any problems related to this medical device should be reported to a physician or healthcare provider.