Medtronic Xomed NIM Trivantage EMG Endotracheal Tube: Class I Recall - Cuff Leak or Cuff Deflation When Inflation Valve Cap Inappropriately Removed

AUDIENCE: Risk Manager, Otolaryngology

ISSUE: FDA notified healthcare professional of a Class I Recall of the Medtronic Xomed, Inc. NIM Trivantage EMG Endotracheal Tube. The firm received 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 can result in serious adverse health consequences, including death.

See the Recall Notice for a listing of affected Lot numbers.

BACKGROUND: 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.

RECOMMENDATION: On March 14, 2013, the firm sent an "URGENT Product Recall Notification" letter to its customers. Customers were instructed to return any affected devices still in their possession. Contact Medtronic ENT Customer Service 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:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm358172.htm