Medtronic Recalls NIM TriVantage EMG Endotracheal Tubes Due to Cuff Leakage
Medtronic is recalling NIM TriVantage EMG Endotracheal Tubes because the cuff may leak during surgery, requiring re-inflation or replacement to maintain patient ventilation.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class I recall, which mandates a severity score of at least 4 per the rubric. Additionally, the defect involves a failure to ventilate a patient during surgery, which constitutes a significant risk of serious injury.
Plain-English summary
Medtronic Xomed, Inc. is recalling the NIM TriVantage EMG Endotracheal Tube. The recall was initiated in March 2013 due to a defect where the tube's cuff may leak during intraoperative deflation. This leakage can compromise the ability to ventilate the patient, necessitating the re-inflation of the cuff or the replacement of the tube during surgery.
The affected product is a sterile, prescription-only medical device designed to facilitate electromyographic (EMG) monitoring of the laryngeal musculature during surgery. The specific product catalog numbers involved are REF 8229705, 8229706, 8229707, 8229708, 8229709, 8229735, 8229736, 8229737, 8229738, and 8229739. The recall covers lot numbers ranging from 205830052 to 206486732, as well as specific lots including 0206516104, 0206516105, 0206516106, 0206516108, 0206520224, 0206520225, 0206520226, 0206520227, 0206520228, 0206520358, 0206542163, 0206545356, and 0206545502.
A total of 2,591 units were distributed worldwide. Distribution included various U.S. states such as Alabama, Arizona, California, Florida, New York, and Texas, as well as international locations including Australia, Canada, Germany, Italy, Norway, Poland, and the United Kingdom. Healthcare facilities and patients who have used these specific devices should contact Medtronic Xomed, Inc. for further instructions regarding the recall.
The recalled product
- 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 electrom
- Manufacturer
- Medtronic Xomed, Inc.
- Affected units
- 2,591
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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