Medtronic Recalls Endotracheal Tube for Monitoring Voice Box in Surgery

The FDA has issued a Class I medical device recall for an endotracheal tube manufactured and sold by Medtronic Xomed, Inc., which is used to monitor the voice box muscles during surgery. According to federal health regulators, multiple reports suggest that the tube’s valve cap may leak when inappropriately removed, posing a risk of serious adverse health consequences, including death.

A Medtronic NIM Trivantage EMG endotracheal Tube recall was announced June 21, after the manufacturer sent a letter to customers in March indicating that the inflation valve cap may create a “cuff leak” or “cuff deflation” when pulled off instead of snapped off sideways.

The endotracheal tube is used by healthcare professionals during surgery to keep the patient’s airway open and to monitor the voice box (laryngeal) muscles when connected to an EMG monitor during surgery.

If the inflation valve cap leaks or is deflated, it will block the patient’s airway and cut off breathing support, potentially resulting in severe or fatal consequences. In the event of the valve cap leaking or deflating, the physician will then have to re-inflate or replace the deflated tube to continue proper breathing support for the patient.

The recalled Endotracheal Tubes were manufactured by Medtronix Xomed Inc., of Jacksonville, Florida from May 22, 2012 through January 22, 2013 and distributed to various healthcare professionals from July 27, 2012 through February 14, 2013.

The product can be identified by locating any of the following recalled lot numbers; 205830052 to 206486732, 0206516104, 0206516105, 0206516106, 0206516108, 0206520224, 0206520225, 0206520226, 0206520227, 0206520228, 0206520358, 0206542163, 0206545356, 0206545502.

Medtronix Xomed sent an “URGENT Product Recall Notification” letter to all of their customers who have the recalled tubes explaining the product, problem, and course of action to be taken to fix the device. Medtronix Xomed advised its customers to check their inventory for affected products and to follow the checklist instructed within the letter and to return the devices accordingly.

Class I medical device recalls is the most serious category of recall, involving situations in which there is a reasonable probability the use of those products will result in severe adverse health consequences including death.

Consumers with question concerning this recall may contact the Medtronix Xomed Inc., Senior Regulatory Affairs Specialist line at 1-800-874-5797.