NIM TriVantage® 8229706 (UDI 00763000033941)Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 00763000033941), received between Jun 1, 2021 and Sep 15, 2026 — classified as 11 injuries, 67 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (34 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 78 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that the endotracheal tube was used intraoperatively; the customer reported that no signal could be monitored during the procedure; after replacing it with a new endotracheal tube of the same model, monitoring was possible. The NIM system shown as self test was failed in the beginning of the case. The patient conditions and machine settings unchanged when the replacement was used. There was a procedure delay and the procedure was extended to 20 minutes. There was no injury to the patient.

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

  MAUDE report 50768574 ↗
• InjuryJul 20, 2026Unintended Deflation

  IT WAS REPORTED THAT DURING THYROIDECTOMY PROCEDURE, APPROXIMATELY 10 MINUTES AFTER INTUBATION, AN AIR LEAK FROM THE ENDOTRACHEAL TUBE WAS DETECTED. THE LEAK WAS EVIDENT AT THE VALVE EXTERNAL CONNECTION. ABOUT 10 MINUTES LATER, THE CUFF WAS REINFLATED ONCE TO CONFIRM THE ISSUE. 7CC AIR WAS USED TO INFLATE THE CUFF INITIALLY AND DURING REINFLATION. AFTER CONFIRMING THE LEAK, THE ENDOTRACHEAL TUBE WAS REPLACED WITH A NEW ONE AND THE PROCEDURE WAS COMPLETED WITH THE BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT.

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

  MAUDE report 25868945 ↗
• InjuryJul 2, 2026Obstruction of Flow; Unintended Deflation

  IT WAS REPORTED THAT DURING THE PROCEDURE, CHANGES IN AIRWAY PRESSURE WERE OBSERVED, SUGGESTING A POSSIBLE AIR LEAK FROM THE EMG TUBE. THE TUBE WAS REPLACED, AND THE SURGERY WAS CONTINUED. POSTOPERATIVELY, USER SUBMERGED THE REMOVED TUBE IN WATER FOR TESTING AND IDENTIFIED AN AIR LEAK AT THE CUFF INFLATION PORT. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THE PROCEDURE WAS EXTENDED FOR 15 MINUTES. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED, PRIOR TO INTUBATION, TESTING WAS PERFORMED, AND INFLATION AND DEFLATION WERE NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25687983 ↗
• MalfunctionMay 26, 2026Unintended Deflation

  IT WAS REPORTED THAT THE BALLOON DID NOT INFLATE DURING USE. THE PRODUCT DID REACH THE PATIENT; HOWEVER, NO PATIENT HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25274813 ↗
• MalfunctionMay 20, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT INTRAOPERATIVELY DURING THYROID SURGERY, A NERVE MONITORING EMG TUBE WAS PLANNED FOR USE; HOWEVER, IMPEDANCE TESTING COULD NOT BE PASSED, AND NO EMG SIGNAL WAS OBSERVED ON THE MONITORING INTERFACE AND THE RECURRENT LARYNGEAL NERVE COULD NOT BE MONITORED THROUGH THIS TUBE THROUGHOUT THE PROCEDURE. EQUIPMENT AND INTERFACE BOX ISSUES WERE RULED OUT. THE ISSUE WAS NOT RESOLVED DURING THE PROCEDURE, AND THE TUBE WAS USED ONLY AS A REGULAR ENDOTRACHEAL TUBE FOR VENTILATION. THE PROCEDURE WAS EXTENDED BY 15 MINS AND WAS COMPLETED WITH THE REPORTED PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25225945 ↗
• MalfunctionMay 18, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING INTRA-OP OF THYROIDECTOMY PROCEDURE, TRIVANTAGE EMG TUBE BALLOON WAS NOT FUNCTIONING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25197179 ↗
• InjuryMay 18, 2026Unintended Deflation

  IT WAS REPORTED THAT THE PACKAGING OF EMG TUBES WERE INTACT. PRIOR TO USE, INFLATION AND DEFLATION TESTS WERE PERFORMED ON THE TUBE CUFFS. DURING RADICAL SURGERY FOR BILATERAL THYROID CARCINOMA, AN AIR LEAK FROM THE EMG TUBE WAS NOTED INTRAOPERATIVELY. THE TUBE WAS REPLACED WITH A NEW ONE, AND THE PROCEDURE WAS CONTINUED. THERE WAS A SURGICAL TIME EXTENSION OF 10 MINUTES. 5 TUBES HAD LEAK ISSUE. VOLUME OF AIR INJECTED TO CUFF WAS NOT MEASURED. THERE WAS NO PATIENT COMPLICATIONS DURING EVENT AND NO IMPACT TO PATIENT OUTCOME.

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

  MAUDE report 25197169 ↗
• InjuryMay 18, 2026Unintended Deflation

  IT WAS REPORTED THAT THE PACKAGING OF EMG TUBES WERE INTACT. PRIOR TO USE, INFLATION AND DEFLATION TESTS WERE PERFORMED ON THE TUBE CUFFS. DURING RADICAL SURGERY FOR BILATERAL THYROID CARCINOMA, AN AIR LEAK FROM THE EMG TUBE WAS NOTED INTRAOPERATIVELY. THE TUBE WAS REPLACED WITH A NEW ONE, AND THE PROCEDURE WAS CONTINUED. THERE WAS A SURGICAL TIME EXTENSION OF 10 MINUTES. 5 TUBES HAD LEAK ISSUE. VOLUME OF AIR INJECTED TO CUFF WAS NOT MEASURED. THERE WAS NO PATIENT COMPLICATIONS DURING EVENT AND NO IMPACT TO PATIENT OUTCOME.

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

  MAUDE report 25197166 ↗
• InjuryMay 18, 2026Unintended Deflation

  IT WAS REPORTED THAT THE PACKAGING OF EMG TUBES WERE INTACT. PRIOR TO USE, INFLATION AND DEFLATION TESTS WERE PERFORMED ON THE TUBE CUFFS. DURING RADICAL SURGERY FOR BILATERAL THYROID CARCINOMA, AN AIR LEAK FROM THE EMG TUBE WAS NOTED INTRAOPERATIVELY. THE TUBE WAS REPLACED WITH A NEW ONE, AND THE PROCEDURE WAS CONTINUED. THERE WAS A SURGICAL TIME EXTENSION OF 10 MINUTES. 5 TUBES HAD LEAK ISSUE. VOLUME OF AIR INJECTED TO CUFF WAS NOT MEASURED. THERE WAS NO PATIENT COMPLICATIONS DURING EVENT AND NO IMPACT TO PATIENT OUTCOME.

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

  MAUDE report 25197165 ↗
• InjuryMay 18, 2026Unintended Deflation

  IT WAS REPORTED THAT THE PACKAGING OF EMG TUBES WERE INTACT. PRIOR TO USE, INFLATION AND DEFLATION TESTS WERE PERFORMED ON THE TUBE CUFFS. DURING RADICAL SURGERY FOR BILATERAL THYROID CARCINOMA, AN AIR LEAK FROM THE EMG TUBE WAS NOTED INTRAOPERATIVELY. THE TUBE WAS REPLACED WITH A NEW ONE, AND THE PROCEDURE WAS CONTINUED. THERE WAS A SURGICAL TIME EXTENSION OF 10 MINUTES. 5 TUBES HAD LEAK ISSUE. VOLUME OF AIR INJECTED TO CUFF WAS NOT MEASURED. THERE WAS NO PATIENT COMPLICATIONS DURING EVENT AND NO IMPACT TO PATIENT OUTCOME.

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

  MAUDE report 25197154 ↗
• MalfunctionMay 4, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT INTRA OPERATIVELY, THE ASSOCIATED ESSENCE SYSTEM WAS USED WITH THE EMG TUBE IN AN ATTEMPT TO PERFORM NEUROMONITORING; HOWEVER, THE SYSTEM WAS UNABLE TO PASS THE IMPEDANCE CHECK AND COULD NOT ENTER THE MONITORING INTERFACE. THERE WAS A DELAY OF 20 MINUTES. THE INTERFACE BOX CONNECTION CABLE WAS RECONNECTED AND THE DEVICE WAS RESTARTED; HOWEVER, THE ISSUE PERSISTED AND THE SYSTEM STILL FAILED TO PASS. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25064521 ↗
• MalfunctionApr 27, 2026Unintended Deflation

  IT WAS REPORTED THAT DURING PARATHYROIDECTOMY, PILOT BALLOON ON NIMS ETT [ENDOTRACHEAL TUBE] NOTED TO BE SLOWLY DEFLATING. CIRCUIT LEAK NOTED AND AIR ADDED TO BALLOON. ABLE TO MAINTAIN PRESSURE IN BALLOON THROUGHOUT CASE WITHOUT EFFECT TO PATIENT VENTILATION. VITAL SIGNS STABLE THROUGHOUT. THERE IS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24997817 ↗
• MalfunctionApr 20, 2026Unintended Deflation

  IT WAS REPORTED THAT FOR THYROID CASE, IT WAS FOUND THE MAIN CUFF HAD NO LEAK BUT FOUND THE LEAK AT THE INTERFACE OF THE PILOT BALLOON AND THE INFLATION VALVE OF THE EMG TUBE. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. THERE WAS NO PATIENT INVOLVED.

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

  MAUDE report 24921774 ↗
• InjuryApr 11, 2026Unintended Deflation

  ADDITIONAL INFORMATION RECEIVED, PRIOR TO INTUBATION, TESTING WAS PERFORMED, AND INFLATION AND DEFLATION WERE NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24851488 ↗
• MalfunctionFeb 25, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THYROID SURGERY, A NERVE MONITORING EMG TUBE WAS USED. FROM THE INITIAL TESTING PROCESS THROUGH TO THE END OF THE SURGERY, THERE WAS NO SIGNAL DETECTED FROM THE EMG TUBE AT ANY POINT. THE POSITION OF THE ENDOTRACHEAL TUBE WAS ADJUSTED, AND EQUIPMENT AND INTERFACE BOX ISSUES WERE RULED OUT. THE POSSIBILITY OF INCOMPLETE METABOLISM OF MUSCLE RELAXANTS WAS EXCLUDED. THERE WAS A PROCEDURAL DELAY OF 20 MINUTES. PROCEDURE WAS COMPLETED WITHOUT USING EMG TUBE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24439886 ↗
• MalfunctionFeb 6, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT AFTER INSERTING THE TUBE INTO THE PATIENT'S THROAT, THE SURGEON FOUND IT WAS TOO THIN AND REPLACED WITH ANOTHER PRODUCT. THERE WAS NO PATIENT IMPACT.

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

  MAUDE report 24276494 ↗
• MalfunctionJan 19, 2026Unintended Deflation

  IT WAS REPORTED THAT INTRA-OP, EMG TUBE DEFLATED AFTER INTUBATION. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24106892 ↗
• MalfunctionJan 17, 2026Unintended Deflation

  IT WAS REPORTED THAT THAT THE THE TUBE DEFLATED UPON INTUBATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24105217 ↗
• MalfunctionJan 16, 2026Unintended Deflation

  IT WAS REPORTED THAT THE TUBE DEFLATED UPON INTUBATION. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24095018 ↗
• MalfunctionJan 12, 2026Break; Unintended Deflation

  IT WAS REPORTED THAT DURING A THYROID SURGERY, AN EMG TUBE WAS USED DURING PREOPERATIVE PREPARATION. IT WAS FOUND THAT THE CUFF WAS LEAKING. PROCEDURE EXTENDED TIME BY 15 MINUTES. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE IS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24031998 ↗
• MalfunctionJan 2, 2026Unintended Deflation

  IT WAS REPORTED THAT DURING THYROID PROCEDURE, THE EMG TUBE HAD SMELLED GAS AND THE CUFF WAS RE-INFLATED MULTIPLE TIMES AFTER SURGERY AND EXTUBATED THE PATIENT AND SUBMERGED THE CUFF VALVE IN WATER NOTICED A SLOW LEAK AND PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 23942496 ↗
• MalfunctionNov 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A THYROIDECTOMY PROCEDURE, THE SURGEON ATTEMPTED TO STIMULATE THE RECURRENT LARYNGEAL NERVE ON ONE SIDE BUT DID NOT GET A STIMULUS RESPONSE. THE SURGEON THEN STIMULATED THE NERVE ON THE OPPOSITE SIDE AND OBTAINED A RESPONSE. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23521533 ↗
• MalfunctionSep 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE OP, THE EMG TUBE IMPEDANCE CHECK COULD NOT BE CLEARED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23082113 ↗
• MalfunctionSep 4, 2025Incorrect, 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 DURING INTRA OPERATIVE THE NIM 3.0 VOCALIS 1 WAS MAKING A LOT OF NOISE AND WILL NOT PASS ELECTRODE CHECK. UPON TROUBLESHOOTING, THE FOLLOWING STEPS WERE TAKEN: OBSERVED THAT VOCALIS 1: LEFT CHANNEL WAS RED, WHILE VOCALIS 1: RIGHT CHANNEL WAS GREEN. SWITCHED PORTS FROM CHANNEL 1 TO CHANNEL 3, BUT THE ISSUE PERSISTED. SWITCHED TO WALL POWER, BUT NO RESOLUTION WAS ACHIEVED, SWITCHED OUT OTHER EMG TUBES, BUT ISSUE PERSISTED, IT WAS NOTED THAT THE ELECTRODES WERE NOT CENTERED PROPERLY. THE USER HAD TO TWIST THE SECOND EMG TUBE IN A NON-STANDARD MANNER TO ACHIEVE A GREEN CHECK MARK. THIS ADJUSTMENT RESOLVED THE NOISE ISSUE, AND THEY WERE ABLE TO MOVE FORWARD WITH THE CASE AFTER SUCCESSFULLY PASSING THE ELECTRODE CHECK. THE PROCEDURE WAS EXTENDED LESS THAN ONE HOUR. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 22960374 ↗
• MalfunctionSep 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback

  ADDITIONAL INFORMATION STATED THAT EMG TUBE PLACEMENT ISSUE.

  Patient problems: Unintended Extubation

  MAUDE report 22960362 ↗

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