NIM TriVantage® 8229737 (UDI 20763000041520)Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 20763000041520), received between Mar 22, 2021 and Apr 21, 2026 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (20 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT INTRA-OP, THE NIM TUBE WAS INSERTED AND THE SYSTEM HAD CONTINUOUS INTERFERENCE; TROUBLESHOOTING WAS DONE, INCLUDING MOVEMENT,<(>,<)> MANIPULATION, AND REPLACEMENT OF THE TUBE; A NEW PATIENT INTERFACE; AND A NIM 3.0 WAS TRIED. INTERFERENCE STOPPED ONCE THE TUBE WAS CHANGED. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 24937295 ↗
• MalfunctionJan 28, 2026Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT DURING HEMITHYROIDECTOMY PROCEDURE, THE NIM WAS MAKING LOTS OF NOISE AND CHANNEL 1 WAS MAKING LOTS OF NOISE WITH A POPPING CORN SOUND AND PERFORMED AN ELECTRODE CHECK ON THE CONSOLE. THE IMPEDANCES ON CHANNEL WHEN WERE CHANGING. A FEW MINUTES LATER, CHANNEL 1 WAS READING "LEAD OFF DETECTED" FOR A FEW SECONDS, THEN THIS WARNING DISAPPEARED AND MUTED THE CHANNEL BRIEFLY WHEN IT WAS MAKING LOTS OF NOISE AND THE CONSOLE WAS LESS NOISY AFTER SWITCHING THE ELECTRODE CHANNELS ON PI BOX. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24197125 ↗
• MalfunctionDec 26, 2025Difficult to Insert; Incorrect, Inadequate or Imprecise Result or Readings; Difficult to Insert; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PREOPERATIVE, THE ELECTRODE ON THE EMG TUBE WAS NOT READING WELL FOR PARATHYROID REMOVAL PROCEDURE. IT TOOK LONGER TO POSITION THE TUBE IN THE CORRECT LOCATION, BY USING THE GLIDE SCOPE TO VISUALIZE THE INTUBATION, KEPT THE PAGE ON THE NIM VITAL MONITOR ON THE CHECK ELECTRODE SCREEN TO MAKE SURE IT WAS BEING PICKED UP AND THE SYSTEM WAS STATED THAT BOTH CHANNELS ARE READ AND AS THEY PROCEEDED TO POSITIONING AND TAPING THE TUBE, IT STOPPED PICKING UP A CHANNEL AND NEEDED TO ADJUST. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23895188 ↗
• MalfunctionDec 11, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THE BALLOON VALVE BROKE DURING SURGERY. THE BALLOON WOULD INFLATE, BUT IT WOULD DEFLATE WHEN WEIGHED. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23777702 ↗
• MalfunctionDec 11, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THE BALLOON VALVE BROKE DURING SURGERY. THE BALLOON WOULD INFLATE, BUT IT WOULD DEFLATE WHEN WEIGHED. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23777658 ↗
• MalfunctionDec 11, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THE BALLOON VALVE BROKE DURING SURGERY. THE BALLOON WOULD INFLATE, BUT IT WOULD DEFLATE WHEN WEIGHED. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23777606 ↗
• MalfunctionDec 11, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THE BALLOON VALVE BROKE DURING SURGERY. THE BALLOON WOULD INFLATE, BUT IT WOULD DEFLATE WHEN WEIGHED. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23777590 ↗
• MalfunctionOct 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A THYROIDECTOMY PROCEDURE, THE ENDOTRACHEAL TUBE DID NOT CONVEY GOOD SIGNALS IN SPITE OF CORRECT PLACEMENT UNDER GOOD VISIBILITY AND GOOD CONTACT TO TRACHEA IT REPEATED ERROR MESSAGES. FOLLOWING RE-INTUBATION WITH A LARGER TUBE, IT WAS OK. THERE WAS A PROCEDURE DELAY FOR 30 MINUTES AND THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT.

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

  MAUDE report 23421603 ↗
• MalfunctionJul 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT THE DURING THYROIDECTOMY THE PATIENT HAD THE INTUBATION CORRECTED. THERE WAS NO SIGNAL RESPONSE BY NERVE STIMULATION. POSITION WAS CHECKED THOROUGHLY AND FOUND TO BE CORRECT. STIMULATION RE-TRIED SEVERAL TIMES, BUT NO SIGNAL ON MONITOR. IT WAS CONCLUDED THAT A SAFE MONITORING OF N. LARYNGAEUS RECURRENS WAS NOT POSSIBLE. PATIENT WAS EXTUBATED AND RE-INTUBATED WITH ANOTHER ENDOTRACHEAL TUBE OF SAME TYPE. THEREAFTER NORMAL SIGNAL AND THE PROCEDURE COULD BE CONTINUED AND COMPLETED. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S) WITH 30 MINS DELAY. THERE WAS NO PATIENT IMPACT. UPON FOLLOW UP IT WAS STATED THAT THE RETURN DID NOT SHOW "0", INDICATING THAT CURRENT IS NOT BEING DELIVERED. THERE WAS NO REPORTED IMPACT. DELAY CAUSED LONGER ANESTHESIA AND INTUBATION TIME.

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

  MAUDE report 22476727 ↗
• MalfunctionJul 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT ELECTRODE CHECK NEVER PASSED ON CHANNEL 2 (RED) ON THE NIM VITAL NEUROMONITOR DURING A THYROIDECTOMY. IT WAS CHECKED SEVERAL TIMES. THEREAFTER ALL CONNECTIONS WERE SWITCHED TO NIM 3.0 RESPONSE WITH SAME RESULT, I.E. RED CHANNEL (#2) NEVER PASSED ELECTRODE CHECK. SAME NEUROMONITOR WAS USED FOR THREE OTHER PATIENTS ON SAME DAY IN SAME OPERATING ROOM WITH SAME SETUP, SO SURGEON CONCLUDED THAT THE TUBE WAS NOT WORKING CORRECTLY. THERE WAS 45 MINUTES DELAY IN THE PROCEDURE AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED WITH THE REPORTED DEVICE. THERE WAS NO KNOWN PATIENT IMPACT REPORTED. ON FOLLOW UP THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22466825 ↗
• MalfunctionJul 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THERE WERE SOME ISSUE WITH THE NIM SYSTEM DURING THE THYROID PROCEDURE. THE CALUS 1 ELECTRODE WAS NOT PROPERLY FUNCTIONING SO THEY TESTED IT AND GOT IT TO WORK AGAIN. WHEN THE UNIT BEGAN TO WORK, ALL ELECTRODES BEGIN TO MALFUNCTION. AFTER MORE ANALYSIS, THEY DETERMINED IT WAS THE TRACHEAL TUBE THAT WAS POSSIBLY DAMAGED AND THAT WAS REPLACED AND CONTINUED ON WITH THE CASE. THERE WAS NO PATIENT IMPACT. VOCALIS 2 STARTED ALARMING AT HIGH AMPLITUDES AND THEN INDICATED ¿ELECTRODE OFF¿. SWAPPED THE RED ELECTRODES FROM CHANNEL 2 TO CHANNEL 3, ACTIVATED CHANNEL 3. THE SAME ISSUE OCCURRED. THEN DEACTIVATED CHANNEL 3 AND SWAPPED THE WORKING CHANNEL 1 BLUE ELECTRODES TO CHANNEL 2 AND THE NON-WORKING CHANNEL 2 RED ELECTRODES TO CHANNEL 1. THE SAME ISSUE OCCURRED (BLUE ELECTRODES CONTINUED TO FUNCTION IN CHANNEL 2, RED ELECTRODES NOW IN CHANNEL 1 WERE NON-FUNCTIONAL). I THEN PUT THE BLUE ELECTRODES BACK IN CHANNEL 1 AND TURNED OFF CHANNEL 2. THE SURGEON PUT THE APS ELECTRODE ON THE VAGUS, AN BEGAN BASELINE. ACHIEVED A BASELINE OF APPROXIMATELY 900 AND THE SURGEON CONTINUED TO OPERATE, THE AMPLITUDE DROPPED TO ABOUT 300 DURING THIS TIMEFRAME. THE PAT

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

  MAUDE report 22466761 ↗
• MalfunctionJul 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT WAS INTUBATED NORMALLY ON A THYROIDECTOMY. IMPEDANCE CHECK AT FIRST SHOWED RED ON BOTH CHANNEL 1 AND 2. FOLLOWING MANIPULATION OF THE TUBE, CHANNEL 2 TURNED GREEN, BUT CHANNEL 1 REMAINED RED. THE HEALTH CARE PROFESSIONAL HAD THE IMPRESSION THAT THE TUBE DID NOT WORK CORRECTLY. THE PATIENT WAS EXTUBATED AND RE-INTUBATED WITH ANOTHER TUBE OF SAME SIZE AND TYPE. AFTER RE-INTUBATION, EVERYTHING WORKED PERFECTLY. THERE WAS 45 MINUTES DELAY. THERE WAS NO PATIENT IMPACT. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22466541 ↗
• MalfunctionJul 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE THYROIDECTOMY CASE STARTED AND THE ROUTINE ELECTRODE CHECK WAS DONE AND BOTH VOCALIS 1 AND 2 CHECKED GREEN. ABOUT 45 MINUTES INTO THE PROCEDURE, THE NERVE MONITORING DEVICE STARTED MAKING A LOT OF NOISE SPECIFICALLY FROM VOCALIS 1. THIS CONTINUED INTERMITTENTLY FOR 4-5 MINUTES. ANOTHER ELECTRODE CHECK WAS DONE AND VOCALIS 1 WAS NOT PASSING THE ELECTRODE CHECK. ANESTHESIA CAME IN TO CHECK THE TUBE. SHE NEVER MOVED THE POSITION OF THE TUBE INSIDE THE PATIENT, BUT SIMPLY EXTERNALLY MOVED THE TUBE SLIGHTLY AND THE ELECTRODE CHECK PASSED. THE PROCEDURE CONTINUED FINE FROM THERE AND THINGS WERE NORMAL. THE SURGEON STATED THAT THIS IS SOMETHING THAT HAPPENS PERIODICALLY. THERE WAS NO DELAY IN THE PROCEDURE AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22465950 ↗
• MalfunctionJul 9, 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) VIA MANUFACTURER REPRESENTATIVE REPORTED THAT DURING TOTAL THYROIDECTOMY THE NIM WAS MAKING A LOT OF NOISE AND THAT THE MACHINE KEPT SAYING ¿CHECK ELECTRODE¿. SHE DID AN ELECTRODE CHECK AND VOCALIS 2 WAS NOT CHECKING GREEN. THEY TRIED ROTATING THE TUBE WITHOUT "SUCCESS" AND CONTINUED THE CASE. THEY ABANDONED THE USE ON THE NIM AND CONTINUED THE CASE WITHOUT INCIDENT. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT(S). THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22456901 ↗
• MalfunctionJul 9, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE PATIENT WAS INTUBATED WITH THE ET TUBE DURING THE INTUBATION PROCEDURE. THE NIM MONITOR DID NOT RECEIVE SIGNALS. THEY REPOSITIONED THE TUBE AND USED A GLIDESCOPE TO CONFIRM POSITION AGAIN. ALL CABLES CHECKED AND REPLUGGED IN AND STILL THE NIM MONITOR DID NOT RECEIVED SIGNALS. THE ET TUBE WAS EXCHANGED FOR A NEW TUBE. THERE WAS NO PATIENT HARM.

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

  MAUDE report 22455547 ↗
• MalfunctionJul 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE DEVICE'S ELECTRODE CHECK FAILED INTERMITTENTLY CHANGING FOR NO APPARENT REASON. THE TUBE LOCATION WAS RECHECKED BY SURGEON AND ANESTHESIOLOGIST. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22435586 ↗
• MalfunctionJul 8, 2025Failure to Conduct; Use of Device Problem; Failure to Conduct; Use of Device Problem

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT THEY HAD AN ISSUE WITH THE TUBE DURING THE PROCEDURE AND WAS NOT ABLE TO USE THE DEVICE CORRECTLY. THE ELECTRODES CHECK WASN'T GOOD; THE ELECTRODE CHANGED FROM POSITIVE POLE TO NEGATIVE POLE ALTERNATIVELY. THEY HAD TO REINTUBATE THE PATIENT WITH A CORRECT TUBE. THERE WAS A 20 MINUTE DELAY. A BACKUP WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

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

  MAUDE report 22435453 ↗
• MalfunctionJul 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE TUBE WAS PLACED IN PATIENT. WHEN NERVE MONITOR SYSTEM RAN ITS SYSTEM CHECK THE BLUE LEAD (VOCALIS 1) WILL NOT REGISTER. THEY TRIED TO TROUBLESHOOT TO GET LEAD TO RECOGNIZE BUT WAS UNSUCCESSFUL. THE SURGEON ASKED FOR A NEW TUBE TO REPLACE FAULTY ONE. THERE WAS NO INTERVENTION PLANNED OR PERFORMED. THERE WAS A 15-20 MINUTE DELAY AS PATIENT NEED TO BE RE-INTUBATED. THERE WAS NO PATIENT IMPACT.

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

  MAUDE report 22383258 ↗
• MalfunctionJul 2, 2025Sensing Intermittently; Sensing Intermittently

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT DURING A THYROID SURGERY. NORMAL PREPARATION. NORMAL INTUBATION. SURGEON IDENTIFIED AND STIMULATED THE RECURRENT NERVE WITH THE NERVE MONITORING DEVICE. THERE WAS NO SIGNAL ON THE NEUROMONITOR. THE EMG TUBE WAS RE-ORIENTED WHILE STIMULATION CONTINUED, BUT STILL NO SIGNAL CURVE. UPON REQUEST OF THE SURGEON, THE PATIENT WAS EXTUBATED AND ANOTHER TUBE OF THE SAME TYPE WAS USED FOR INTUBATION. UPON STIMULATION OF THE NERVE WITH THE NEW TUBE, EMG RESPONSE SIGNAL CURVES WERE SEEN ON THE NEUROMONITOR AND THE SURGERY COULD BE CONTINUED NORMALLY. THERE WAS AN APPROXIMATE OF 30 MINUTES DELAY FOR RE-POSITIONING AND - AS THIS DID NOT IMPROVE THE SITUATION - EXTUBATION. THEN RE-INTUBATION WITH ANOTHER TUBE OF SAME TYPE THERE WAS NO PATIENT IMPACT THERE AFTER.

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

  MAUDE report 22382970 ↗
• MalfunctionJul 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE ELECTRODE CHECK HAS BEEN OK AT THE BEGINNING OF THE SURGERY BUT DURING THE SURGERY THEY LOST THE SIGNAL WITHOUT ANY REASON. THE ELECTRODE CHECKING WAS NOT OK DURING THE SURGERY, MAYBE A LOSS OF VOCAL CORDS CONTACT. THERE WAS 25 MINUTES DELAY AND THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22381833 ↗
• 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 THE ELECTRODE CHECK WAS COMPLETED WITH NO CONCERNS PRIOR TO RIGHT THYROIDECTOMY CASE. 20 MINUTES INTO THE CASE CHANNEL 1 WOULD MAKE SIGNIFICANT NOISE IN THE 1000-3000MV RANGE. ELECTRODE CHECK PERFORMED, INDICATING THAT THE BLUE/CHANNEL 1 WAS FUNCTIONING INTERMITTENTLY (GREEN CHECK TO RED X) CAUSING THE ERRONEOUS NOISE. BLUE CHANNEL WAS DEACTIVATED AND ELECTRODES SWAPPED TO THE PURPLE CHANNEL, CHANNEL 3. THE ISSUE CONTINUED. THE BLUE ELECTRODES (NOW CHANNEL 3) WERE DEACTIVATED AND CHANNEL 2, RED ELECTRODES WERE USED TO MONITOR THE RIGHT SIDE RLN. THE PROCEDURE WAS EXTENDED FOR 5 MINS AND WAS COMPLETED WITH THE REPORTED PRODUCT. THE PATIENT WAS ALIVE - NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22381298 ↗
• MalfunctionJul 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTHCARE PROVIDER (HCP) VIA SALES MANUFACTURER REPORTED THAT THE BLUE CORDS WERE NOT REGISTERING AT ALL DESPITE VARIOUS ATTEMPTS DURING USE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22380309 ↗
• MalfunctionMar 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THYROIDECTOMY PROCEDURE, WHILE DISSECTING, THE NURSE STATED THAT NOTHING WAS STIMMING. NO TWEEDLE, NO EVENT TONES. ETC. THE NIM ITSELF WAS REBOOTED BUT THE ISSUE STILL PERSISTED LEADING THEM TO BELIEVE IT WAS AN ISSUE WITH THE TUBE. USER "TOOK EXTRA CARE IN THE SETUP". SURGEON COULDN'T GET ANY RESPONSE FOR NERVE OR TISSUE. THERE WAS SURGICAL DELAY OF 20 MINUTES. ELECTRODE CHECKS WERE PASSED. THERE WAS NO STIMULUS DELIVERY SOUND AND NO STIM RETURN. ANESTHETIC AND/OR MUSCLE RELAXANT WAS USED AND SHORT ACTING ONLY. NO DAMAGE NOTICED ON THE DEVICES. STIMULUS AND THRESHOLD SET TO DEFAULT SETTINGS. THE PROCEDURE WAS COMPLETED WITHOUT MONITORING. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. THERE WAS NO PATIENT IMPACT. AFTER EVENT (2 DAYS LATER) REP TESTED THE NIM CONSOLE. IT WORKED AS INTENDED AND GAVE THE NORMAL RESPONSES WITH THE SIMULATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21718093 ↗
• MalfunctionMar 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THYROIDECTOMY PROCEDURE WHILE DISSECTING, THE NURSE STATED THAT NOTHING WAS STIMMING. NO TWEEDLE, NO EVENT TONES. ETC. THEY CHECKED THE CONNECTIONS AND EVERYTHING WAS SETUP PROPERLY. THE SURGEON WAS ON NERVE AND THE SYSTEM WAS SILENT. THERE WAS SURGICAL DELAY OF 20 MINUTES. ELECTRODE CHECKS WERE PASSED. THERE WAS NO STIMULUS DELIVERY SOUND AND NO STIM RETURN. ANESTHETIC AND/OR MUSCLE RELAXANT WAS USED AND SHORT ACTING ONLY. NO DAMAGE NOTICED ON THE DEVICES. STIMULUS AND THRESHOLD SET TO DEFAULT SETTINGS.THE PROCEDURE WAS COMPLETED WITHOUT MONITORING. THERE WAS NO PATIENT IMPACT. AFTER EVENT (2 DAYS LATER) REP TESTED THE NIM CONSOLE. IT WORKED AS INTENDED AND GAVE THE NORMAL RESPONSES WITH THE SIMULATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21718043 ↗
• MalfunctionJan 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHEN USING THE NIM D.7 PROBE FOR A TOTAL THYROIDECTOMY, THE ELECTRODE DID NOT WORK AND DID NOT FULFILL ITS ROLE. HCP CHOSE ANOTHER SIMILAR DEVICE OF THE LARGER SIZE D.7.5 WHICH WORKED. THERE WAS NO PATIENT IMPACT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21215007 ↗

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