NIM Trivantage® 8229706 (UDI 00643169782587)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00643169782587), received between Jan 2, 2018 and Jul 11, 2025 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (10 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 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.

Recalls naming this device

1. Nov 7, 2023Open, 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 ↗

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AFTER PATIENT WAS INTUBATED, NIM WIRES WERE PLUGGED INTO THE HANDPIECE TO PERFORM AN ELECTRODE CHECK. VOCALIS 1 FAILED THE ELECTRODE CHECK. CIRCULATOR MADE SURE WIRES WERE PLUGGED COMPLETELY INTO THE HANDPIECE AND A NEW HANDPIECE WAS ALSO TRIED WITH THE SAME RESULTS. CIRCULATOR CONTACTED WITH MEDTRONIC REP AND HE SUGGESTED TO HAVE ANESTHESIA RELEASE TENSION ON THE TUBE. THE SAME RESULT OCCURRED AFTER RELEASING TENSION AND USING A GLIDE SCOPE TO VERIFY THE TUBE PLACEMENT HAD NOT CHANGED. A NEW 6.0MM NIM TUBE WAS OBTAINED. AFTER PLACEMENT OF THE NEW TUBE, THE ELECTRODE CHECK PASSED WITHOUT ISSUE. THERE IS NO KNOWN PATIENT INJURY. THE TUBE WAS BEING USED IN A PATIENT CASE. AFTER IT FAILED, IT WAS REMOVED AND CASE CONTINUED WITH A NEUROVISION BRAND TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 22477704 ↗
• MalfunctionJul 9, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A DISTRIBUTOR REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE TUBE ELECTRIC RESISTANCE HAD NO FUNCTION PRE-OPERATIVELY. THERE WAS NO PATIENT INVOLVEMENT. ON FOLLOW UP THE DEVICE DID NOT FUNCTION DURING SET-UP. THE MONITOR SHOWED INCORRECT. TROUBLESHOOTING WAS TO CHANGE A NEW PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22456716 ↗
• MalfunctionJul 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE LEFT ELECTRODE WAS NOT WORKING PROPERLY PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22382925 ↗
• MalfunctionJul 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A DISTRIBUTOR REPORTED VIA MANUFACTURER REPRESENTATIVE THAT DURING A THYROIDECTOMY SURGERY, WHEN THE DOCTOR INSERTED THE TUBE INTO THE PATIENT'S BODY, THE DOCTOR FOUND THAT THE ELECTRODE CHECK ON THE RIGHT WAS ALWAYS CROSSED. THE DOCTOR TRIED TO ADJUST THE DEPTH OF THE ENDOTRACHEAL TUBE AND ROTATE THE ENDOTRACHEAL TUBE, BUT IT WAS USELESS. FINALLY, THE DOCTOR REPLACED A NEW ENDOTRACHEAL TUBE TO COMPLETE THE OPERATION. THE CURRENT STIM RETURN SHOWS NOT 0. IT WAS ALSO MENTIONED THAT THE ELECTRODE CHECK ON THE RIGHT SIDE CANNOT BE DETECTED, SO NIM SHOWS A CROSS. THE USER INDICATES THAT THE INTERMITTENT ISSUE WAS A CONNECTION ISSUE. THERE WAS NO PLANNED/INTERVENTION PERFORMED. THERE WAS 10 MINUTES DELAY IN THE SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE WAS NO PATIENT IMPACT.

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

  MAUDE report 22382403 ↗
• MalfunctionJul 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A THYROID LOBECTOMY THE DEVICE WAS PLACE FOR MONITORING THROUGHOUT THE CASE, THE RIGHT ELECTRODE INTERMITTENTLY NOT WORKING. NIM MACHINES CHANGED OUT. THE RIGHT ELECTRODE STILL DID NOT WORK. THE DOCTOR FOUND THAT THE RIGHT RED WIRE CONNECTED TO ENDOTRACHEAL TUBE HAD ISSUE. THERE WAS NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22381529 ↗
• MalfunctionJul 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem; Deformation Due to Compressive Stress; Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE TUBE WAS KINKED AND HAD ELECTRODES MALFUNCTION DURING THE PROCEDURE. THE ELECTRODES FAILED TO SHOW PROPER I MPEDANCES/CONNECTION AND CORRUPTED THE PATIENT DATA WITH ARTIFACT DURING USE, ACTIVE MONITORING DURING THE TOTAL THYROIDECTOMY PROCEDURE. THE ISSUE WAS NOT EVIDENT IMMEDIATELY UPON ATTEMPTING TO MONITOR AS IT OCCURRED RANDOMLY THROUGHOUT THE PROCEDURE. THE DEVICE DID NOT SHOW 0 AS FULL STIM WAS SENT AND RECEIVED. THE ELECTRODES CHANNELS WERE GOING OUT. THE UNIT WAS USED FOR THE FIRST TIME AND IT DID NOT DISPLAYED ANY ERROR MESSAGE. THE GROUND AND RETURN ELECTRODES WERE REPLACED, POD REPLACED, ALL CONNECTIONS TO BASE, AMPLIFIERS, AND STIM BOX CHECKED. THERE WAS NO DELAY WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF MONITORING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22381042 ↗
• MalfunctionJul 2, 2025Image Display Error/Artifact; Incorrect, Inadequate or Imprecise Result or Readings; Image Display Error/Artifact; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTH CARE PROVIDER REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE PATIENT UNDERWENT BILATERAL THYROIDECTOMY. THIS CATHETER WAS USED TO MONITOR THE RECURRENT LARYNGEAL NERVE DURING THE SURGERY. BEFORE THE SURGERY, THE ANESTHESIOLOGIST USED THE NERVE MONITORING ENDOTRACHEAL TUBE. AFTER INTUBATION, THE WIRE WAS CONNECTED TO THE NERVE MONITOR. THERE WAS NO RESPONSE. DURING THE EARLY INTUBATION TEST, THE DEBUGGING TEST HAS NOT PASSED. THERE WAS A PROMPT THAT THE DEVICE HAS FAILED TO PASS THE TEST. AFTER MANY ADJUSTMENTS, BUT STILL NO RESPONSE. REPLACED IT WITH ANOTHER CATHETER, IT COULD BE USED NORMALLY, AND THERE WAS NO ADVERSE EVENT AND NO PATIENT INJURY.

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

  MAUDE report 22380963 ↗
• 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 PROFESSIONAL (HCP) REPORTED THAT THE BROKEN TUBE DID NOT CONNECT PROPERLY WITH THE MONITIOR AND WAS CAUSING ERROR READINGS. AT THE TIME OF CONNECTION OF THE ET TUBE AND PROBES TO THE MONITOR, THE MONITOR WAS GOING OFF AND PICKING UP A LOT OF ARTIFACT WITHOUT ANY KNOWN REASON. THEY DECIDED TO CHANGE OUT THE MONITORS TO SEE IF THAT RESOLVED THE ISSUE. IT DID NOT. THE TEAM THEN CHANGED OUT THE PROBES HOWEVER DID NOT RESOLVE THE ISSUE. LASTLY, THE TEAM DETERMINED THE ET TUBE SHOULD BE EXCHANGED OUT AND REPLACED WITH A NEW ONE. THIS RESOLVED THE ISSUE. THERE WAS NO PATIENT IMPACT.

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

  MAUDE report 22380329 ↗
• MalfunctionApr 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING PROCEDURE, THE ELECTRODE CHECK KEPT X FOR BOTH CHANNEL. USER CHANGED TO ANOTHER PATIENT INTERFACE, BUT STILL X FOR BOTH CHANNELS. THERE WAS A PROCEDURE DELAY OF 10 MINUTES. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. THE PATIENT STATUS IS REPORTED AS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED, REPORTED THAT THE ELECTRODES FAILED IMMEDIATELY AFTER INTUBATING THE EMG TUBE. THE ELECTRODES WERE INTERCHANGED TO CHANNEL 3 AND 4 BUT STILL THE ISSUE COULD NOT BE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21907053 ↗
• MalfunctionFeb 13, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT, PRE-OP, WHEN THE ANESTHETIST TEST THE CUFF BY AIR, HE FOUND THAT THE CUFF LEAKED AIR. THE ANESTHETIST TRIED TO REINFLATE THE CUFF BUT THE CUFF STILL LEAKED AIR. SO, THE ANESTHETIST CHANGED A NEW ENDOTRACHEAL TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21373140 ↗
• MalfunctionFeb 11, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT PRIOR TO USE, WHEN AN ANESTHESIOLOGIST TESTED THE BALLOON BEFORE SURGERY, IT WAS FOUND THAT THE BALLOON WAS LEAKING AIR. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21353350 ↗
• MalfunctionFeb 11, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT BEFORE THE SURGERY, THE ENDOTRACHEAL TUBE BALLOON WAS FOUND TO BE LEAKING DURING THE EXAMINATION WHEN ANESTHESIA IN THE HOSPITAL. REPLACED THE ENDOTRACHEAL TUBE. PRODUCT DIDN'T COME IN CONTACT WITH PATIENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21352639 ↗
• InjuryAug 27, 2024Break; Unintended Deflation; Break; Unintended Deflation

  IT WAS REPORTED THAT WHEN INFLATING THE CUFF OF THE ENDOTRACHEAL TUBE, THE CUFF WAS FOUND TO BE RUPTURED, DURING USE, IT CAME INTO CONTACT WITH SHARP OBJECTS, AND THE INFLATION VOLUME DID NOT EXCEED 5ML., REPLACED THE ENDOTRACHEAL TUBE. PROCEDURE WAS DELAYED BY 10 MINUTES.THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE IS NO PATIENT INJURY. ADDITIONAL INFORMATION RECIEVED AFTER FOLLOW UP THAT BEFORE INTUBATION, THE TUBE CUFF WAS CHECKED AND FOUND NO PROBLEMS. AFTER THE INTUBATION WAS COMPLETED, THE CUFF WAS FOUND TO BE RUPTURED DURING INFLATION.

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

  MAUDE report 20076734 ↗
• MalfunctionSep 18, 2023Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT THERE WAS A NOISE FROM THE TUBE DURING THE THYROIDECTOMY PROCEDURE AND THE DOCTOR SAID SHE WASN'T GETTING GOOD NERVE RESPONSES WHEN SHE STIMULATED. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. NO PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED, THE DEVICE WAS SHOWING "MEASURING AT THE SAME AMOUNT THE STIMULUS WAS SET AT". THE ONLY WAVEFORM WAS WHEN A POSITIVE EMG RESPONSE WAS GIVEN ALONG WITH THE 4 PULSES PER SEC AND A BIPHASIC WAVE FORM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17764898 ↗
• MalfunctionFeb 3, 2021Failure to Sense; Gas/Air Leak; Failure to Sense; Gas/Air Leak

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA MANUFACTURING REPRESENTATIVE THAT DURING A THYROIDECTOMY PROCEDURE, THE AIR WAS LEAKING IN THE CUFF AND SENSOR WAS NOT FUNCTIONING HALF WAY THROUGH THE OPERATION (NO NERVES CAN BE DETECTED). THERE WAS NO PLANNED/INTERVENTION PERFORMED. THERE WAS 20 MINUTES DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT(S). THE PATIENT WAS ALIVE - NO INJURY. ON FOLLOW-UP, IT WAS REPORTED THAT THE LEAK WAS SLOWLY, NOT ALL AT ONCE. THE AIRWAY HAD ALREADY BEEN ESTABLISHED WHEN THE LEAK WAS DISCOVERED. THE LEAKING WAS NOTED 30 MINUTES AFTER THE PATIENT WAS INTUBATED. IT WAS THE INITIAL USE OF THE TUBE. IT WAS MENTIONED THAT THE STIM FUNCTIONED NORMAL BUT NO NERVE CAN BE FOUND. FOR TROUBLESHOOTING, IT WAS REPORTED THAT NO MUSCLE RELAXANTS WERE ADDED DURING THE PROCEDURE, STIM WORKS NORMAL, HCP LOWERED THE THRESHOLD, UPPER THE CURRENT, CHECK LIST "ALL PASS", AND THE INTUBATION POSITION IS CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11273010 ↗
• MalfunctionOct 21, 2020Leak/Splash; Leak/Splash

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT DURING A PROCEDURE FOR THYROIDECTOMY SURGERY, THE CUFF WAS NOT BROKEN, BUT IT WILL LEAK DURING PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT(S). THE PATIENT WAS ALIVE - NO INJURY. ON FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMED THAT THE TUBE WAS PATENCY PRIOR TO INTUBATION THE PATIENT. 15CC OF AIR WAS USED TO INFLATE THE CUFF. THE PATIENT WAS INTUBATED 40 MINUTES AFTER SURGERY. THE AIRWAY HAD ALREADY BEEN ESTABLISHED WHEN THE LEAK WAS DISCOVERED. DUE TO THE LEAK, THE PATIENT DID NOT REQUIRED REINTUBATION BUT NEED TO RE-INFLATE THE CUFF. IT WAS ALSO REPORTED THAT IT WAS THE INITIAL USE OF THE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10710700 ↗
• MalfunctionDec 28, 2018Break; Break

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A DISTRIBUTOR THAT THE ANESTHETIST FOUND THE BALLOONS OF TWO TUBES WERE BROKEN WHEN RUNNING TEST AFTER THE INTUBATION DURING A THYROIDECTOMY PROCEDURE. ANOTHER TUBE WAS USED TO COMPLETE THE SURGERY. THE HCP NOTED THAT IT WAS THE INITIAL USE OF BOTH TUBES. THE SURGERY WAS DELAYED FOR ABOUT THIRTEEN (13) MINUTES. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8202637 ↗
• MalfunctionDec 28, 2018Break; Break

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A DISTRIBUTOR THAT THE ANESTHETIST FOUND THE BALLOONS OF TWO TUBES WERE BROKEN WHEN RUNNING TEST AFTER THE INTUBATION DURING A THYROIDECTOMY PROCEDURE. ANOTHER TUBE WAS USED TO COMPLETE THE SURGERY. THE HCP NOTED THAT IT WAS THE INITIAL USE OF BOTH TUBES. THE SURGERY WAS DELAYED FOR ABOUT THIRTEEN (13) MINUTES. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8202625 ↗
• MalfunctionSep 25, 2018Unable to Obtain Readings; Use of Device Problem; Noise, Audible; Unable to Obtain Readings; Use of Device Problem; Noise, Audible

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT WHEN THEY WERE USING A NERVE MONITORING DEVICE, THERE WAS A PROBLEM WITH THE ENDOTRACHEAL TUBE AND THEY EXPERIENCED ISSUES WITH THE LEADS ON THE TUBE. THEY COULD NOT MONITOR THE NERVE RESPONSE DURING A THYROIDECTOMY PROCEDURE. THE SYSTEM WAS NOT RECEIVING RESPONSES FROM THE LEFT OR RIGHT SIDE AND THE SYSTEM WAS SOUNDING. TROUBLESHOOTING WAS DONE AND FOUND RIGHT SIDE WAS NOT WORKING AS IT FAILED TO RECEIVE ANY IMPULSES FROM LEFT SIDE. THE HCP DISCONTINUED TO USE THE DEVICE AND SYSTEM FOR MONITORING. THE PROCEDURE WAS COMPLETED WITHOUT USE OF THE MONITORING SYSTEM AND TROUBLESHOOTING WAS NOT CONTINUED. THERE WAS A SLIGHT DELAY IN THE PROCEDURE DUE TO TROUBLESHOOTING. THERE WAS NO PATIENT IMPACT AND THERE WAS NO RE-INTUBATION NEEDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7905142 ↗
• MalfunctionSep 11, 2018Appropriate Device Problem Term/Code Not Available

  NERVE INTEGRITY MONITOR EMG ENDOTRACHEAL TUBE FAILED TO RECOVER ANY IMPULSES FROM LEFT SIDE. RIGHT SIDE ELECTRODES WORKED. SYSTEM CHECKED WITH ASSISTANCE FROM REP, WHICH CONFIRMED PROBLEM WITH ET TUBE. ALL OTHER EQUIPMENT HAD BEEN CHANGED AND THE PROBLEM CONTINUED. THE SURGEON WAS UNABLE TO DETECT NERVE RESPONSE WHILE COMPLETING A THYROIDECTOMY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7863866 ↗
• MalfunctionAug 20, 2018Inflation Problem; Inflation Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE ENDOTRACHEAL TUBE'S PILOT BALLOON DID NOT ALLOW THE CUFF TO BE INFLATED DURING THE PROCEDURE. AIR COULD NOT BE INJECTED INTO THE CUFF. THERE WAS NO KNOWN PATIENT IMPACT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7796635 ↗
• MalfunctionJan 2, 2018False Negative Result; False Negative Result

  THE CUSTOMER REPORTED THAT THE NIM TRIVANTAGE EMG TUBE WAS NOT PICKING UP VOCAL CORD MOVEMENT (NOT SENSING) AT THE BLUE SECTION (CONTACT ELECTRODE) INTRAOPERATIVELY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7157255 ↗

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-0743-2022 · Dec 22, 2021 · Open, Classified
  NIM TRIVANTAGE EMG Endotracheal Tube
• 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