Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm Recalled by Medtronic Xomed, Inc. Due to In March 2013, Medtronic issued a recall of...

Date: March 4, 2013
Company: Medtronic Xomed, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Xomed, Inc. directly.

Affected Products

REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA STERILE Rx Only The electrodes are designed to make contact with the patient's vocal cords to facilitate electromyographic (EMG) monitoring of the laryngeal musculature during surgery when connected to a multi-channel EMG neuromonitoring device.

Quantity: 2,591 units

Why Was This Recalled?

In March 2013, Medtronic issued a recall of the NIM TriVantage EMG Endotracheal Tube due to cuff leakage in the intraoperative cuff deflation which then requires re-inflation or replacement of the deflated tube in order to ensure the continued ventilation of the patient.

Where Was This Sold?

This product was distributed to 29 states: AL, AZ, AR, CA, CO, FL, GA, HI, IL, IN, KS, KY, MD, MA, MI, MN, MT, NH, NJ, NY, NC, OH, PA, RI, SC, TX, UT, VA, WA

Affected (29 states)Not affected

About Medtronic Xomed, Inc.

Medtronic Xomed, Inc. has 26 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report