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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Medtronic Xomed, Inc.: NIM TriVantage EMG Endotracheal Tubes Recalled for Nerve Monitoring Failure

Agency Publication Date: January 10, 2024
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Summary

Medtronic Xomed, Inc. is recalling approximately 80,569 NIM TriVantage EMG Endotracheal Tubes due to reports of electrical interference and loss of nerve monitoring during surgery. The device may experience noise issues, high impedance, or lead-off alerts, which can result in intermittent or complete loss of the nerve monitoring signal. This recall affects various sizes (6.0mm, 7.0mm, and 8.0mm) distributed worldwide since November 2023.

Risk

The loss of nerve monitoring during surgery can prevent surgeons from identifying critical nerves, potentially leading to accidental nerve damage or permanent paralysis. While no specific injury counts were provided in the recall notice, the reported 'lead-off' and high impedance issues indicate the monitoring system may fail when it is needed most to protect patient safety.

What You Should Do

  1. Check your surgical inventory for NIM TriVantage EMG Endotracheal Tubes with model (REF) numbers 8229706, 8229707, 8229708, 8229736, 8229737, or 8229738.
  2. Verify if your specific devices are affected by matching the Serial Numbers and GTINs provided in the product list, such as GTIN 00643169782587 or 00763000033941.
  3. Immediately stop using any endotracheal tubes identified as part of the affected lots and quarantine them to prevent clinical use.
  4. Contact Medtronic Xomed, Inc. at 1-800-633-8766 or visit their website to coordinate the return of affected products and discuss potential replacements.
  5. Healthcare providers should consult with their surgical teams to ensure alternative nerve monitoring solutions are available if these tubes are removed from service.
  6. For additional questions or to report an adverse event, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

healthcare provider or manufacturer consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: NIM TriVantage EMG Endotracheal Tubes (6.0MM ID)
Model / REF:
8229706
UPC Codes:
00643169782587
00763000033941
Lot Numbers:
0225892912
0225894523
0225904858
0226227428
0226246448
0226246716
0226253848
0226258673
0226276006
0226294121
0226299303
0226299304
0226321727
0226350207
0226604403
0226628515
0226648757
0226684520
0226718176
0226745452
0225750658
0225785080
0225785081
0225785083
0225785085
0225785587
0225787473
0225974682
0225998102
0225998104
0226099513
0226121951
0226130941
Product: NIM TriVantage EMG Endotracheal Tubes (7.0MM ID)
Model / REF:
8229707
UPC Codes:
00643169373099
00643169782594
00763000033958
Lot Numbers (165):
0225784379
0225784380
0225798573
0225809609
0225832077
0225841439
0225848733
0225877835
0225952300
0225952301
0225994034
0226020502
0226030100
0226121428
0226124551
0226130051
0226130055
0226150740
0226166004
0226337996
0225803180
0225805468
0225805470
0225824531
0225825616
0225828951
0225832074
0225841440
0225846915
0225846916
0225848736
0225848738
0225849141
0225869998
0225870000
0225877834
0225886691
0225915233
0225915542
0225921185
0225929260
0225929261
0225932768
0225934163
0225956683
0225962826
0225972240
0225980517
0225983909
0225983910
Product: NIM TriVantage EMG Endotracheal Tubes (8.0MM ID)
Model / REF:
8229708
UPC Codes:
00643169373105
00763000033965
Lot Numbers:
0225785422
0225785424
0225785467
0225787472
0226086712
0225785421
0225785423
0225785425
0225785466
0225785468
0225809611
0225975149
0225998251
0225998253
0226004208
0226004209
0226121950
0226130937
0226130938
0226130939
Product: NIM TriVantage EMG Endotracheal Tubes (6MM ID 3PK)
Model / REF:
8229736
UPC Codes:
20763000041513
Lot Numbers:
0225998248
Product: NIM TriVantage EMG Endotracheal Tubes (7MM ID 3 PK)
Model / REF:
8229737
UPC Codes:
00763000041526
20763000041520
Lot Numbers:
0225908326
0225908328
0226103711
0225908183
0225908184
0225908185
0225908327
0225908329
0225908330
0225908332
0225908334
0226177141
Product: NIM TriVantage EMG Endotracheal Tubes (8MM ID 3 PK)
Model / REF:
8229738
UPC Codes:
20763000041537
Lot Numbers:
0225785470

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93600
Status: Active
Manufacturer: Medtronic Xomed, Inc.
Sold By: Authorized Medical Distributors; Specialty Medical Suppliers
Manufactured In: United States
Units Affected: 80569 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.