NIM TriVantage® 8229738 (UDI 20763000041537)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20763000041537), received between Jul 9, 2021 and Feb 23, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).

2 FDA recall records name this device's identifier, 2 still open.

1 other recall 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 18, 2026.

Recalls naming this device

1. Nov 7, 2023Class IIOpen, Classified

   Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,

   Z-0696-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Dec 22, 2021Class IIOpen, Classified

   There is potential for multiple issues due to a manufacturing nonconformity.

   Z-0743-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING TOTAL THYROIDECTOMY PROCEDURE, THE ELECTRODE CHECK, EVERYTHING WAS GREEN AND SHOWED GOOD IMPEDANCE. DURING STIMULATION WITH THE PROBE, THERE WAS MUSCLE CONTRACTION, BUT NO NERVE SOUND OR BIPHASIC CURVE WAS EVER DETECTED, ALTHOUGH THE CONTRACTION AND THE NERVE WERE CLEARLY VISIBLE TO THE NAKED EYE. USER CHANGED THE TUBE FROM THE SAME MODEL AND SIZE, IT WORKED WITHOUT ANY ISSUES. ANESTHESIA ASSUMES THAT THE FIRST TUBE MAY HAVE BEEN POSITIONED SLIGHTLY MORE OUTWARD THAN THE ONE PLACED SUBSEQUENTLY, BUT IN THAT CASE, THEY DO NOT UNDERSTAND WHY THE CHECK SHOWED EVERYTHING GREEN AND CORD IMPEDANCES 0.1. THRESHOLD WAS 100 AND UV AND THRESHOLD WAS SET TO 100. MUSCLE RELAXANT WAS USED JUST IN THE BEGINNING BUT THEN REVERTED THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE WAS 20 MINUTES DELAY IN PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24411167 ↗
• InjuryNov 10, 2025Unintended Deflation; Unintended Deflation

  ADDITIONAL INFORMATION RECEIVED, THE TUBE WAS CHECKED PRIOR USE AND IT WAS FUNCTIONED PROPERLY. THE SYRINGE 10 ML(CC) WAS USED TO INFLATE THE ENDOTRACHEAL TUBE CUFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 23507830 ↗
• MalfunctionSep 2, 2025Difficult to Remove; Obstruction of Flow; Difficult to Remove; Obstruction of Flow

  IT WAS REPORTED THAT DURING THE EXTUBATING PROCEDURE OF A PATIENT INTUBATED WITH A EMG TUBE, THE PROCESS BEGAN BY DEFLATING THE BALLOON WITH A 10 ML SYRINGE. UPON INSPECTION, THE EXTERNAL CUFF APPEARED DEFLATED. HOWEVER, DURING THE EXTUBATING ATTEMPT, THE PATIENT CLENCHED THE PROBE TIGHTLY BETWEEN THEIR TEETH, MAKING REMOVAL DIFFICULT. RESISTANCE WAS ENCOUNTERED, AND IT WAS OBSERVED THAT THE INTERNAL CUFF WAS OVERINFLATED, DESPITE THE EXTERNAL CUFF APPEARING VISIBLY DEFLATED. IT WAS NOTED THAT THE CUFF PRESSURE HAD BEEN CHECKED AT THE START OF THE PROCEDURE USING A PRESSURE GAUGE, SHOWING A PRESSURE BELOW 30 MMHG. A VOICE CHECK WAS THEN PERFORMED ON THE PATIENT. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22931626 ↗
• MalfunctionJul 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT DURING PARATHYROID EXPLORATION THE TRIVANTAGE NIM WAS NOISIER THAN TYPICAL. BOTH CHANNELS WERE SHOWN TO BE NOISY, ORANGE ARTIFACT WAVEFORM WAS PRESENT, FREE RUN EMG AT APPROX 60UV. REBOOT OF SYSTEM COMPLETED. ELECTRODE CHECK SHOWED THAT THE RED CHANNEL WAS A RED "X". SWAPPED BLUE AND RED ELECTRODES IN PATIENT INTERFACE BOX, RED 'X' SWAPPED TO THE BLUE CHANNEL. SUSPECTED DAMAGE TO THE RED ELECTRODES. SURGEON COMPLETED THE PROCEDURE NOT MONITORING THE RIGHT SIDE. SUGGESTION MADE TO REINTUBATE OR ROTATE THE TUBE FOR FUNCTIONAL ELECTRODES TO BE IN CONTACT WITH OPERATIVE SIDE. THERE WAS A 15 MINUTE DELAY. ON FOLLOW UP, SURGEON COMPLETED THE PROCEDURE NOT MONITORING THE RIGHT SIDE. THE RED ¿X¿ INDICATING THE ELECTRODE NOT FUNCTIONING INDICATED THERE WAS SOMETHING WRONG WITH THE RED ELECTRODES. THERE WAS NO REPORTED VISIBLE DAMAGE, THE RED ¿X¿ INDICATING THE ELECTRODE WAS NOT FUNCTIONING INDICATED THERE WAS SOMETHING WRONG WITH THE RED ELECTRODES. THE ANESTHETIST INDICATED TO THE CLINICAL NURSE LEAD THAT SOME TORSION HAD BEEN APPLIED WHEN POSITIONING THE TUBE. THE NERVE WAS NOT VISIBLE, NO USE OF THE STIM PROBE AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22381808 ↗
• MalfunctionMay 27, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT DURING THYROIDECTOMY PROCEDURE, AS SOON AS THE PROBE WAS USED FOR STIMULATION AND THE SURGEON WAS SURE THE STRUCTURE STIMULATED WAS A NERVE, THE SURGEON WAS UNABLE TO OBTAIN A RESPONSE TO THE NIM VITAL. THERE WAS A STIM DELIVERY TONE. THE STIMULATION LEVEL WAS INCREASED TO 2.0 MA AND NO RESPONSE WAS OBSERVED. THE RIGHT STIMULATION LEVEL US DISPLAYED AND THE RIGHT STIM RETURN VALUE WAS DISPLAYED. THE THRESHOLD LEVEL WAS AT 100UV DURING THE PROCEDURE. THE SURGEON OBSERVED A MOVEMENT OF THE VOCAL CORD MUSCLES. SHE THEREFORE DECLARED A FALSE NEGATIVE RESPONSE FROM NIM VITAL. EVENT CAPTURE WAS TURNED OFF AND IT WAS SHOWING BACKGROUND ACTIVITY, BUT IT WAS UNCLEAR IF THE STIMULATION WAS CREATED OR NOT EMG ACTIVITY. THE POSITIONING OF THE NIM TRIVANTAGE TUBE WAS VALIDATED BEFORE AND AFTER SURGERY. NO MUSCLE RELAXANT WAS USED. THE SURGERY WAS COMPLETE WITH A FINGER OVER VOCAL CORD MUSCLE WHILE STIMULATING TECHNIQUE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22085454 ↗
• MalfunctionNov 25, 2024Difficult to Insert; Material Too Rigid or Stiff; Difficult to Insert; Material Too Rigid or Stiff

  IT WAS REPORTED THAT DURING PROCEDURE THE PROBE BENDS TOO MUCH DURING THE OPERATION, DESPITE THE SAFETY MEASURES TAKEN, MAKING IT IMPOSSIBLE TO UNBEND. THE OPERATION HAD TO BE STOPPED 3 TIMES TO REPOSITION THE PROBE. THERE WAS 20 MINUTES DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. THERE WAS NO PATIENT INJRUY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20769051 ↗
• MalfunctionJun 19, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN ADULT, THE TUBE STARTED LEAKING. NO HARM TO THE PATIENT. THEY STOPPED THE PROCEDURE AND GOT ANOTHER ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14741274 ↗
• MalfunctionJul 9, 2021Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT DURING THYROIDECTOMY THE DEVICE HAD NO STIMULATION. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S) WITH 30 MINUTES DELAY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12142574 ↗

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-1420-2013 · Mar 4, 2013 · Terminated
  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