FDA Medical Device Recalls (openFDA)
Medtronic Xomed, Inc.: 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.
- Recall number
- Z-1420-2013
- Recalling firm
- Medtronic Xomed, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2013-03-04
- Posted
- 2013-06-04
- Terminated
- 2014-01-30
- Reason
- 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.
- Root cause
- Use error
- Action
- The firm, Medtronic Xomed, Inc. sent an "URGENT Product Recall Notification" letter dated March 14, 2013, to its U.S. and International customers. The letter described the product, problem and actions to be taken. The customers were instructed to return any affected devices still in their possession per the following procedure: 1. Check inventories for the affected products listed on the enclosed checklist. 2. Fill-in the "quantity on-hand" column on the checklist. 3. Fax checklist to Medtronic ENT at 1-904-296-2386. 4. If you have any of the subject product, contact Medtronic ENT Customer Service at 1-800-874-5797 to arrange for returns and replacement or credit. 5.When returning products, clearly mark the outside of the container Returned Goods Authorization (RGA) number. If you have any questions regarding the subject action or the content of the letter, contact Gabriela Anchondo at 904-279-7550.
- Quantity
- 2,591 units
- Distribution
- Worldwide distribution: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, MD, MI, MN, MT, NC, NH, NJ, NY, OH, PA, RI, SC, TX, UT, VA, and WA; and countries of : Australia, Canada, Germany, Italy, Norway, Poland and United Kingdom.
- Lot, serial or model codes
- Product Catalog Numbers: REF 8229705, 8229706, 8229707, 8229708, 8229709, 8229735, 8229736, 8229737, 8229738, 8229739. Lot Numbers: 205830052 to 206486732. 0206516104, 0206516105, 0206516106, 0206516108, 0206520224, 0206520225, 0206520226, 0206520227, 0206520228, 0206520358, 0206542163, 0206545356, 0206545502.
- 510(k) numbers
- ["K112686"]
- PMA numbers
- not on file
- Product code
- ETN
- Firm FEI
- 1045254
- Firm city
- Jacksonville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28