The FDA has issued a Class I recall of the NIM Trivantage EMG Endotracheal Tube by Medtronic Xomed Inc.

The NIM Trivantage Endotracheal Tube is used by health care professionals to continuously monitor the voice box (laryngeal) muscles during surgery. The device keeps the patient’s airway open for ventilation and for electromyography (EMG) monitoring of the laryngeal muscles when connected to an appropriate EMG monitor.

On March 14, 2013, Medtronic sent an urgent product recall notification letter to its customers, following complaints of “cuff leak” or “cuff deflation” occurring when the inflation valve cap is inappropriately removed (pulled off, instead of snapped-off sideways). This requires the physician to re-inflate or replace the deflated tube to ensure the continued breathing support of the patient. Use of this recalled product may result in serious adverse health consequences, including death, according to the alert issued by the FDA.

Customers are instructed to return any affected devices still in their possession by contacting Medtronic at 1-800-874-5797 to arrange for returns.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program online or by phone at (800) 332-1088.