NIM Trivantage® 8229736 (UDI 20643169782635)Recalls & reported problems
Medtronic Xomed, Inc. · EMG TUBE 8229736 3PK NIM TRIVANTAGE 6MM · Class 2
All models of NIM TriVantage (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20643169782635), received between Nov 19, 2018 and Nov 19, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Material Deformation” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K112686); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Material Deformation1
Patient problems
- Airway Obstruction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 19, 2018Material Deformation; Material Deformation
A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE ENDOTRACHEAL TUBE KINKED (FOLDED) AFTER THE MOUTH AND THE PATIENT BECAME BLUE. THE VENTILATION WAS NOT CORRECT DURING A PART OF THE INTERVENTION.
Patient problems: Airway Obstruction
MAUDE report 8086544 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K112686. One submission often covers many models, so check the product and lot details in each record.
- Z-0696-2024 · Nov 7, 2023 · Open, ClassifiedNIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ID; d) 8229736, 6MM ID 3PK; e) 8229737, 7MM
- Z-0743-2022 · Dec 22, 2021 · Open, ClassifiedNIM TRIVANTAGE EMG Endotracheal Tube
- Z-1420-2013 · Mar 4, 2013 · TerminatedREF 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
Other STIMULATOR, NERVE devices
- NIM Vital NIM4CM01Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls260 reports
- NIM TriVantage® 8229707Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls176 reports
- NIM® 8229306Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall1 death167 reports
- NIM Vital™ NIM4CPB1Medtronic Xomed, Inc. · STIMULATOR, NERVE3 recalls45 reports
- NIM Trivantage® 8229707Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall142 reports
- NIM® 8229307Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall138 reports
- NIM TriVantage® 8229706Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls78 reports
- NIM-Response® 8253002Medtronic Xomed, Inc. · STIMULATOR, NERVE171 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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