Medtronic Xomed, Inc., recalled its NIM Trivantage EMG Endotracheal Tube due to risk of leakage. This product was manufactured from May 22, 2012 through Jan. 22, 2013 and distributed from July 27, 2012 through Feb. 14, 2013.
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.
The firm received complaints of "cuff leak" or "cuff deflation" occurring when the inflation valve cap was 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.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall