NIM TriVantage® 8229708 (UDI 00763000033965)Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00763000033965), received between Jun 7, 2021 and Sep 11, 2026 — classified as 7 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (26 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 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736580 ↗
• MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736546 ↗
• MalfunctionMay 29, 2026Break; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, INTRA-OP FOR THYROID SURGERY, THE DEVICE WAS UNABLE TO USE, AS IT WAS FAULTY. DURING SURGERY, A RED X ON THE SCREEN DURING THE RECHECK AND THEY HAD TO CHANGE TUBES DURING THE OPERATION, TUBE EXCHANGE, VERY HIGH RISK OF REINTUBATION, 20-30 MINUTE DELAY, INTUBATION DONE BY THE ANESTHESIOLOGIST. THERE WAS NO PATIENT IMPACT.

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

  MAUDE report 25326977 ↗
• InjuryMay 25, 2026Unintended Deflation

  IT WAS REPORTED THAT DURING USE, BOTH REFERENCED 7 AND 8 MM TUBES WERE INFLATED AT BALLOONS DID NOT HOLD PRESSURE. BACKUP DEVICE USED TO PROCEED WITH SUCCESSFUL CASE. THERE IS NO INJURY TO THE PATIENT.

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

  MAUDE report 25268398 ↗
• MalfunctionApr 22, 2026Unintended Deflation

  IT WAS REPORTED THAT INTRAOPERATIVELY, THAT THE CUFF WOULD NOT INFLATE. IT HAD A HOLE IN IT. THERE IS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24957782 ↗
• MalfunctionApr 6, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PRE-OP, THE SENSING PATCH IN THE EMG TUBE APPEARED TO BE NOT ADHERING PROPERLY. THEY HAD DOUBTS ABOUT THE PRODUCT AND THEREFORE DID NOT OPEN THE PACKAGING AND NEVER USED IT. THERE WAS NO DAMAGE NOTICED IN THE PACKAGING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787238 ↗
• MalfunctionMar 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A CASE TO REPORT THAT THE SYSTEM WAS NOT STIMULATING. DURING TROUBLE SHOOTING PASSED ELECTRODE CHECK. ONLY OPERATING ON LEFT, WHICH WAS SELECTED IN MONITORING SCREEN STIM 1.0, THRESHOLD 100, THRESHOLD DECREASED TO 85. TUBE PLACEMENT CORRECT, SIZE 8 (MALE), CALLER CONFIRMED PLACEMENT ON CALL. THE DEVICE WAS ORIGINALLY WIRELESS AND MOVED TO WIRED WITH SAME OUTCOME. PRASS SELECTED FOR STIM 1, CALLER OPENED ANOTHER ONE. STIM 1 ACTIVE IN MONITORING CONSOLE PLUGGED INTO DEDICATED WALL OUTLET. TRIED ANOTHER PI BOX WHEN INTERFERENCE IT IS BEING PICKED UP. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531007 ↗
• MalfunctionMar 2, 2026Unintended Deflation

  IT WAS REPORTED THAT PREOPERATIVE, WHEN HEALTHCARE PROFESSIONAL CHECKED THE CUFF BEFORE USE WITH THE PATIENT, THEY FOUND THAT THE CUFF HAS LEAK SO THEY CHANGE TO USE THE NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480871 ↗
• 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 24411164 ↗
• MalfunctionFeb 13, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT INTRAOPERATIVELY, THEY, WERE DOING MONITORING WITH THE NIM VITAL DEVICE FROM BOTH SIDES. EVERYTHING WAS FINE ON THE RIGHT SIDE (GREAT RESPONSE FROM THE LRN AND VAGUS); THEY THEN STARTED THE OTHER SIDE AND OBTAINED ONE RESPONSE FROM THE LEFT LRN AND EVENTUALLY LOST THE SIGNAL FROM THAT SIDE AND NEVER RECOVERED. THE TROUBLESHOOTING PERFORMED WAS FIRST, THEY CHECKED THE MONITORING EQUIPMENT FOR DYSFUNCTION: EVERYTHING WAS STILL PROPERLY CONNECTED, AND ELECTRODES CHECK WERE ALL GOOD. SECONDLY, ENDOTRACHEAL TUBE MALPOSITION AND MISUSE OF PROLONGED MUSCULAR ANALGESICS: THEY OBTAINED A POSITIVE HIGH RESPONSE ON THE CONTRALATERAL LRN STIMULATION. FROM THE ANESTHESIA, THE TUBE WAS IN THE MEDIAN LINE AND WITH THE MARK ¿20¿ RIGHT ON THE LOWER TEETH. NO LOCAL ANALGESICS WERE USED, AND NO SIGNIFICANT SECRETIONS WERE PRESENT. AT THE SAME TIME THAT WE GOT A LOS ON THE LEFT SIDE THE RIGHT SIDE ALWAYS SHOWED A GREAT RESPONSE. THE DOCTORS TOLD ME THAT THIS IS THEIR THIRD TIME OCCURRING SOMETHING LIKE THIS AND WITHOUT ANY NERVE INJURY AFTERWORD. WE ALSO FILMED A VIDEO FROM THAT STIMULATION (VAGUS FROM THE LEFT SIDE WITH NO RESPONSE FROM NIM), THEY SAW THE CONTRACTION OF THE SURRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24330602 ↗
• MalfunctionDec 1, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED DURING INTRA-OP FOR TOTAL THYROIDECTOMY PROCEDURE THAT THE ANESTHESIOLOGIST INFLATES THE BALLOON AND REALIZES AFTER A FEW MINUTES THAT IT HAS NO AIR LEFT. SHE REPEATS THE PROCEDURE AND QUICKLY LOSES THE CAPNOGRAPHY WAVEFORM. SHE REPEATS THE PROCEDURE FOUR MORE TIMES AND THE SAME THING HAPPENS, SO SHE DECIDES TO CHANGE THE TUBE DUE TO THE LEAK IN THE BALLOON. THE TUBE WAS CHECKED BEFORE PLACEMENT BY INJECTING AIR INTO THE CUFF, AND WITHOUT PRESSURE IT APPEARED TO FUNCTION CORRECTLY. A 10CC SYRINGE WAS USED WITH 20CC OF AIR TO INFLATE THE CUFF. THE ANATOMY WAS NOT COMPLICATED, AND THERE WERE NO ISSUES WITH INTUBATION. TUBE DID NOT KINKED. THE TEST CONSISTED OF INFLATING IT AND THEN IMMEDIATELY DEFLATING IT. PROCEDURE WAS EXTENDED WITH 30 MINUTES AND COMPLETED WITH BACK-UP PRODUCTS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23689613 ↗
• MalfunctionJul 23, 2025Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED BY HEALTH CARE PROFESSIONAL THAT THE TRIVANTAGE TUBE WAS DAMAGED INTRA OP. THERE WAS NO PATIENT IMPACT. THE PROCEDURE WAS EXTENDED FOR LESS THAN AN HOUR. RESOLUTION WAS CONFIRMED DURING THE CALL. UPON FOLLOW UP IT WAS REPORTED THAT THERE WAS VISUAL AND/OR AUDIBLE INDICATORS ALERTED THE USER OF THE ISSUE. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22574780 ↗
• InjuryJul 22, 2025Obstruction of Flow; Unintended Deflation; Obstruction of Flow; Unintended Deflation

  IT WAS REPORTED THAT; THE TUBE WAS CHECKED PRIOR TO BE USED. PATIENT WAS INTUBATED, TRANSFERRED IN THEATRE WHERE IT SHOWED THERE WAS A LEAK. CUFF INFLATED CO2 WAVES NOTED ON SCREEN, CUFF DEFLATED PATIENT EXTUBATED. THE PATIENT WAS REINTUBATED WITH AN ALTERNATIVE TUBE TO COMPLETE THE PROCEDURE. THE PATIENT IS ALIVE WITH NO INJURY.

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

  MAUDE report 22566587 ↗
• MalfunctionJul 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT IN THE OPERATING ROOM, WHILE ATTEMPTING TO UTILIZE THE NIM MONITOR TO FOR NERVE STIMULATION DURING A THYROIDECTOMY. WITH TWO OF THE THREE TUBES WE WERE UNABLE TO MAINTAIN A SOLID SIGNAL FOR VOCALIS 1 AND VOCALIS 2 CHANNELS EVEN UPON VERIFICATION OF PLACEMENT WITH THE GLIDE SCOPE AND VISUALIZATION. ABLE TO SUCCESSFULLY MAINTAIN SIGNAL WITH THE THIRD TUBE. NO KNOWN PATIENT IMPACT.

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

  MAUDE report 22519526 ↗
• MalfunctionJul 16, 2025Image Display Error/Artifact; Inappropriate Audible Prompt/Feedback; Image Display Error/Artifact; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT SITE IS USING A NIM THAT WILL NOT PASS ITS ELECTRODE CHECK. UPON PLUGGING IN THE PATIENT SIMULATOR, THE ELECTRODE CHECK PASSED NORMALLY. ADJUSTING THE TUBE ALLOWED THE ELECTRODE CHECK WOULD PASS INTERMITTENTLY. THE SITE ALREADY ATTEMPTED TO REPLACE BOTH THE TUBE AND THE GROUND ELECTRODE. THEY CHANGED FROM A 7.0 MM TUBE TO AN 8.0 MM TUBE. THE ELECTRODE CHECK DOES NOT PASS BUT IT WILL STIMULATE. EVEN THRESHOLD IS ON BUT NOT CAUSING THE ISSUES. THEY USED THE MINI SCREEN ATTACHED TO A METAL POLE. WHEN THEY TOUCH THE PATIENT INTERFACE IT MADE VERY EXCESSIVE NOISE AS IF ALOT OF METAL TOUCHED IT ( ITS A MIX BETWEEN STATIC AND LIKE METAL CLANGING). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22517859 ↗
• MalfunctionJul 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT DURING A PROCEDURE FOR THYROIDECTOMY SURGERY, THE TUBE'S BLUE ELECTRODE WOULD NOT REGISTER, WOULD NOT GET A GREEN CHECK MARK IN THE ELECTRODE CHECK. THEY TRIED SWITCHING INTERFACE BOXES, A NEW MONITOR AND SWITCHED OUT TUBES. STILL THE SAME RESULT. THEY COULD NOT GET THE ELECTRODE TO READ WITH ALL INTERVENTIONS ATTEMPTED. CASE WAS ABORTED. THERE WAS A 60-MINUTE DELAY IN THE PROCEDURE. THE PATIENT WAS ALIVE - NO INJURY.

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

  MAUDE report 22516597 ↗
• MalfunctionJul 15, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTH CARE PROVIDER REPORTED THAT THE CHANNEL 2 WAS GOING OUT OF CONTROL. TURNED OFF ON THE MAINFRAME. THE DELAY WAS MINIMAL. THE PATIENT WAS NOT INJURED IN THE CASE. THE CHANNEL 2 WAS HAVING VERY STRONG ARTIFACT OR NERVE ACTION ON THE SCREEN WITH NUMBERS IN THE THOUSANDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505234 ↗
• MalfunctionJul 15, 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 AT THE START OF THE CASE, THEY INTUBATED THE PATIENT BUT COULDN¿T GET THE NERVE MONITOR TO RECOGNIZE THE SECOND CHANNEL. THEY EXTUBATED THE PATIENT AND REINTUBATED, BUT STILL COULDN¿T GET IT TO REGISTER ON THE SECOND CHANNEL. THEY CALLED THE MANUFACTURER REPRESENTATIVE AT THAT POINT AND TRIED TROUBLESHOOTING. WITH THE SECOND TUBE STILL IN THEY PULLED IN A SECOND NERVE MONITOR TO SEE IF THAT WAS THE ISSUE, BUT THE SECOND CHANNEL STILL WOULD NOT REGISTER. THEY DECIDED TO ABANDON NERVE MONITORING FOR THE CASE BUT LEFT IN THE EMG TUBE TO VENTILATE THE PATIENT. THERE WAS NO KNOWN IMPACT TO THE PATIENT, ASIDE FROM THE 2 EXTUBATIONS. IT WAS REPORTED THAT THEY WERE UNABLE TO USE NERVE MONITORING DURING THE CASE, WHICH IMPACT MY OPERATIVE TECHNIQUE AND TIME REQUIRED, HOWEVER THERE WAS NO MEASURABLE CONSEQUENCE FOR THE PATIENT IN THIS CASE.

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

  MAUDE report 22504552 ↗
• MalfunctionJul 15, 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 AT THE START OF THE CASE, THEY INTUBATED THE PATIENT BUT COULDN¿T GET THE NERVE MONITOR TO RECOGNIZE THE SECOND CHANNEL. THEY EXTUBATED THE PATIENT AND REINTUBATED, BUT STILL COULDN¿T GET IT TO REGISTER ON THE SECOND CHANNEL. THEY CALLED THE MANUFACTURER REPRESENTATIVE AT THAT POINT AND TRIED TROUBLESHOOTING. WITH THE SECOND TUBE STILL IN THEY PULLED IN A SECOND NERVE MONITOR TO SEE IF THAT WAS THE ISSUE, BUT THE SECOND CHANNEL STILL WOULD NOT REGISTER. THEY DECIDED TO ABANDON NERVE MONITORING FOR THE CASE BUT LEFT IN THE EMG TUBE TO VENTILATE THE PATIENT. THERE WAS NO KNOWN IMPACT TO THE PATIENT, ASIDE FROM THE 2 EXTUBATIONS. ON FOLLOW-UP, IT WAS REPORTED THAT THEY WERE UNABLE TO USE NERVE MONITORING DURING THE CASE, WHICH IMPACT MY OPERATIVE TECHNIQUE AND TIME REQUIRED, HOWEVER THERE WAS NO MEASURABLE CONSEQUENCE FOR THE PATIENT IN THIS CASE.

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

  MAUDE report 22504457 ↗
• MalfunctionJul 9, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT DURING A PROCEDURE FOR THYROID SURGERY, THE TUBE COULD NOT BE USED BECAUSE ONE SIDE ELECTRODE OF THE TUBE WAS SUSPECTED TO BE FRACTURED (IT WAS UNKNOWN WHICH SIDE WAS FRACTURED). IT WAS THOUGHT THAT THE DOCTOR JUDGED THAT THERE WAS NO PROBLEM WITH THE FUNCTION OF THE TUBE, ONLY THE SUSPECTED DISCONNECTION OF THE ELECTRODE PART, AND CONTINUED TO USE IT. WHEN THE INTUBATION PROCEDURE WAS STARTED, EXTUBATION AND RE-INTUBATION WAS A SIGNIFICANT EXTENSION OF THE PROCEDURE BOTH IN TERM OF PATIENT AND IN THE FIELD. THEREFORE, IT WAS NOT REPLACED. THERE WAS NO PLANNED/INTERVENTION PERFORMED. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22455240 ↗
• MalfunctionJul 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT DURING PARATHYROIDECTOMY PROCEDURE, REMOVAL OF LEFT INFERIOR PARATHYROID, THE LEFT (BLUE) ELECTRODE WAS NOT WORKING PROPERLY. THE SURGEON DID APPLY PRESSURE ON ELECTRODE WHERE INTERFACED WITH THE TUBE, AND GOT A SUCCESSFUL ELECTRODE CHECK AND STIMULATION OF RECURRENT LARYNGEAL NERVE (RLN). WITHOUT PRESSURE ON THE TUBE, THE ELECTRODE CHECK WOULD FAIL FOR VOCALIS 1. THEY WERE ABLE TO CONTINUE CASE AND PATIENT WAS NOT HARMED. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. USER REPORTED THAT THE DEVICE REQUIRED THE NURSE TO PRESS ON THE TUBE WHERE THE ELECTRODE IS CONNECTED, TO GET A ¿GREEN CHECK¿ IN THE ELECTRODE CHECK. OTHERWISE, THE ELECTRODE CHECK FOR THE LEFT SIDE (BLUE) GOT A ¿RED CHECK¿ INDICATING IT WAS NOT PICKING UP THAT ELECTRODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22435267 ↗
• MalfunctionJul 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT A NERVE MONITORING EMG TUBE HAS ALL GREEN CHECK MARKS AT THE BEGINNING OF THE SURGERY ON THE NERVE MONITORING CONSOLE. DURING THE PROCEDURE THE BLUE LEADS WENT TO RED X¿S. COULD NOT GET THEM BACK TO GREEN. TRIED PLUGGING INTO ANOTHER CONSOLE AND PLUGGING INTO THE PATIENT INTERFACE. THERE WAS A 30 MINUTE DELAY AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22434786 ↗
• MalfunctionJul 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT AFTER INTUBATING THE ENDOTRACHEAL TUBE, WHEN THE TUBE WAS CONNECTED TO THE PATIENT INTERFACE, CHECK MARK DID NOT LIGHT UP DURING ELECTRODE CHECK. THE TUBE FIXING POSITION WAS ADJUSTED BY THE ANESTHESIOLOGY DEPARTMENT, BUT CHECK MARK AND X WERE REPEATED AND UNSTABLE, SO IT WAS SUSPECTED THAT ELECTRODE WAS DEFECTIVE OR THE CORD WAS POORLY CONTACTED, AND THE TUBE WAS REPLACED. THE CORD WAS DISCONNECTED AND RECONNECTED SEVERAL TIMES, BUT IT DIDN'T IMPROVE. INVESTIGATION IS REQUESTED. THERE WAS 10 MINUTES DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. THE TUBE WAS INTUBATED INTO THE PATIENT, THE ELECTRODE WAS CHECKED. THE TUBE POSITION WAS ALSO ADJUSTED WITH THE COOPERATION OF THE ANESTHETIST. STIM HAS NOT BEEN CONFIRMED. STIMULATION PROBE ETC. WAS NOT CONNECTED. THERE WAS NO PATIENT IMPACT.

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

  MAUDE report 22381511 ↗
• 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 HAD NO WAVEFORM DURING THE THYROID TUMOR RESECTION. THERE WAS NO INTERVENTION PLANNED OR PERFORMED. THERE WAS NO DELAY WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCTS. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED MENTIONED THAT THE TUBE WAS NOT REPLACED WITH A SPARE PRODUCT. THE REASON WHY IT WAS NOT REPLACED BECAUSE IT WAS DISCOVERED DURING THE PROCEDURE, SO IT SEEMED THAT THE PROCEDURE WAS CONTINUED WITHOUT REPLACING IT. ON FOLLOW UP, REP MENTIONED WAVEFORM SHOULD HAVE STOPPED COMING OUT. TROUBLESHOOTING WAS IMPEDANCE CHECK PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22381479 ↗
• MalfunctionJul 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT WHEN THIS PRODUCT WAS USED FOR THYROID PROCEDURE, ONLY VOCALIS2 DID NOT HAVE THE CHECK MARK IN THE IMPEDANCE CHECK AND "×" MARK STILL PERSISTED. EVEN THOUGH THE POSITION OF INTUBATION TUBE WAS ADJUSTED BY ANESTHESIOLOGY DOCTOR, CHECK MARK WAS NOT DISPLAYED, SO A SPARE PRODUCT WAS USED. THEN A CHECK MARK WAS DISPLAYED. THE PROCEDURE WAS EXTENDED FOR 15 MINUTES. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22381027 ↗

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