FDA Issues New Recommendations Following Medtronic Endotracheal Tube Recall

Federal regulators are warning doctors about the risks associated with recalled Medtronic endotracheal tubes, following more than a dozen complaints of problems involving airway obstructions, including at least two deaths.

Information about the Medtronic endotracheal tube recall was first posed by the Food and Drug Administration (FDA) on September 12, indicating that doctors intubating patients need to avoid overinflating the silicone cuff to avoid airway obstructions. However, the agency issued updated recommendations only a week later, to make sure healthcare providers in the operating room are aware of the recall.

The FDA issued an update regarding the recalled Medtronic Xomed Endotracheal Tubes on September 16, highlighting the risks of oxygen deprivation, brain damage, or death that may be caused by continued use of the device.

The update includes both the NIM CONTACT Reinforced EMG Endotracheal Tube and NIM Standard Reinforced EMG Endotracheal Tube.

If the tube obstructs a patient’s air way and does not ventilate properly, patients may suffer oxygen deprivation, brain damage, or death as a result. So far, 15 reports of airways obstructions have been reported in connection to this recall, leading to three injuries and two deaths.

The FDA classified the Medtronic Xomed Endotracheal Tube recall as a class I recall, the most serious type of a recall, because use of the recalled device has the potential to cause serious harm or death to the patient.

Recommendations to Healthcare Professionals

The recall included a warning for operating room healthcare providers, including anesthesiologists, nurse anesthetists, and surgeons to review the recall letter, and follow certain steps if an airway obstruction occurs.

Healthcare providers should Immediately deflate the cuff and attempt to ventilate. If ventilation cannot be re-established:

• Extubate the endotracheal tube
• Reestablish ventilation with bag valve mask or laryngeal mask airway
• Reintubate with a new non-silicone endotracheal tube or re-intubate with a new, larger Xomed Endotracheal Tube

The update calls for healthcare professionals to be aware of the recall and risks and follow the instructions for use included in Medtronic’s original customer letter, which was sent only to customers in April, long before the FDA defined the action as a Class I recall. The update suggests the FDA is concerned these devices are still being actively used after the recall notice.

In its original recall notice, the FDA also called for doctors to take care when manipulating the tube’s position because it can cause the cuff to inflate and stretch over the tube opening, potentially leading to airway obstructions. They should also make sure to deflate the cuff before any manipulation or repositioning of the tube is done.

The FDA indicates it will continue to monitor reports of airway obstruction and ventilation failure with these devices.

The agency requests all adverse events related to the Medtronic Xomed Endotracheal Tube be reported to the FDA’s MedWatch Adverse Event Reporting Program.