NIM TriVantage® 8229707 (UDI 00763000033958)Recalls & reported problems

Summary

The FDA's MAUDE database contains 176 adverse event reports that list this exact device (DI 00763000033958), received between Jul 27, 2021 and Sep 24, 2026 — classified as 12 injuries, 164 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (98 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 176 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Unintended Deflation

  It was reported that during a Thryoid procedure, they found that the EMG tube "had a hole in it." Site removed tube and intubated the patient with a new EMG tube and continued with case, the procedure was extended for less than 1 hour, the cuff and tube checked prior to use to ensure proper functionality and they worked properly. 10CC Syringe was used to inflate the endotracheal tube cuff, 10CCair was used to inflate the cuff. There was no patient impact.

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

  MAUDE report 50877496 ↗
• MalfunctionSep 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that system could not pass electrode check for the blue electrode after placing the EMG tube. Site replaced EMG tube which resolved the issue. There was no patient impact.

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

  MAUDE report 50797766 ↗
• MalfunctionSep 15, 2026Unintended Deflation

  It was reported that, pre-op, the endotracheal tube cuff could not be inflated because a cuff leak was identified during pre-inflation of the tube. No damage was noticed on the outer packaging. The issue was identified after opening the tube from a sealed package, and no visual damage was noted on the cuff. This issue was discovered before intubating the patient. The hospital used a 10 mL syringe for inflation and inflated the cuff with 5 mL of air. The procedure was completed by replacing the tube with a new endotracheal tube. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779281 ↗
• MalfunctionSep 15, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that intra-op, the EMG tube was used, but no signal could be detected. Neuromuscular blockade, equipment issues, and probe-related issues have already been ruled out. The procedure was delayed by 10 minutes and was completed by replacing the EMG tube. The tube was used after opening from a sealed package and no signs of damage were found. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50767567 ↗
• MalfunctionSep 11, 2026Unintended Deflation

  It was reported that pre-op, a leak was found in the cuff of the endotracheal tube during inspection and inflation could not be done properly, making it unusable. The procedure was completed after replacement of the tube. The tube was used after opening from a sealed package and there was no damage noticed in the packaging. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50728141 ↗
• MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that intra operatively, a connection failure occurred, rendering the device unusable. The procedure was completed after replacing the EMG tube with one of the same model. There was no patient injury.

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

  MAUDE report 50579779 ↗
• MalfunctionAug 3, 2026Incorrect, Inadequate or Imprecise Result or Readings

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

  MAUDE report 50112929 ↗
• MalfunctionJul 20, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THYROIDECTOMY, THE SURGEON COULD ONLY PERFORM ONE SIDE OF THE THYROIDECTOMY BECAUSE THE STIMULATION ON THE RIGHT SIDE (BLUE CABLE) DID NOT WORK. AT THE SAME TIME, THE STIMULATION ON THE LEFT SIDE WORKED NORMALLY WITHOUT PROBLEMS. SURGERY WAS STOPPED AFTER THE FIRST SIDE. PATIENT HAD TO BE RE-OPERATED TWO DAYS LATER ON THE SECOND SIDE. THERE WAS SURGICAL TIME EXTENSION FOR 60 MIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25869734 ↗
• MalfunctionJul 17, 2026Unintended Deflation

  IT WAS REPORTED THAT DURING PRE-OP, THE EMG TUBE HAD CUFF LEAKAGE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25851496 ↗
• MalfunctionJul 8, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE-OP, THE ENDOTRACHEAL TUBE FAILS TO ESTABLISH A SIGNAL CONNECTION WHEN CONNECTED TO THE INTERFACE BOX. THE PROCEDURE WS COMPLETED WITH A BACKUP DEVICE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25755734 ↗
• MalfunctionJun 19, 2026Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT, INTRAOPERATIVELY, IT PRESENTED INTERFERENCE WITHOUT DELIVERING AUDITORY FEEDBACK DURING STIMULI. THE STIMULUS SIDE WAS CHANGED TO 2 OR AT THE INTERFACE OF THE EQUIPMENT WITHOUT SUCCESS. THE ANESTHESIOLOGIST WAS ASKED TO REPLACE THE TUBE TO RESOLVE THE PROBLEM, BUT THE PHYSICIAN PREFERRED NOT TO PROCEED BECAUSE THE PATIENT WAS USING A PACEMAKER THAT COULD BE CAUSING THE INTERFERENCE. IN VIEW OF ALL THAT HAPPENED, THE DOCTOR DECIDED TO CONTINUE THE PROCEDURE WITHOUT MONITORING. THERE WAS A DELAY OF 20 MINUTES. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25556740 ↗
• MalfunctionJun 5, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A THYROID PROCEDURE, CHANNEL 1 WOULD INTERMITTENTLY DISPLAY A LEAD OFF DETECTED MESSAGE. SITE PERFORMED ELECTRODE CHECKS THROUGHOUT CASE AND FOUND NO ISSUES. SITE ALSO CHECKED EMG TUBE POSITIONING AND FOUND THAT TUBE HAD NOT SHIFTED. THE TUBE WAS USED AFTER OPENING FROM A SEALED PACKAGE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25405708 ↗
• MalfunctionMay 27, 2026

  ETT [ENDOTRACHEAL TUBE] INSERTED AND BALLOON WOULD NOT INFLATE. ETT EXTRACTED AND DISCARDED. A SECOND ET TUBE INSERTED AND BALLOON INFLATED, BUT LEAKS WERE HEARD/NOTED THROUGHOUT CASE. SURGEON ABLE TO COMPLETE CASE WITH THIS SECOND ETT. AFTER EXTUBATION, RESIDENT EXAMINED ETT AND DID NOT VISUALIZE ANY DEFECTS, BUT NOTED THE BALLOON WAS SLOW TO INFLATE. HE THEN PLACED ETT IN SALINE AND INFLATED BALLOON. BUBBLES WERE NOTED, INDICATING A HOLE IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25299648 ↗
• MalfunctionMay 25, 2026Break; Unintended Deflation

  IT WAS REPORTED THAT DETACHMENT OF THE INFLATION CUFF TIP WAS IDENTIFIED IN AN EMG TUBE DURING THE PREOPERATIVE CHECK. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267477 ↗
• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THAT PRE-OP, EMG TUBE CUFF WAS DAMAGED. THERE WAS NO DAMAGE TO THE PACKAGING, ISSUE WAS FOUND WHEN PRODUCT WAS OPENED FROM THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211915 ↗
• MalfunctionMay 13, 2026Unintended Deflation

  IT WAS REPORTED THAT PRIOR TO USE, THE ANESTHESIOLOGIST DISCOVERED A LEAK IN THE EMG TUBE. THE PROCEDURE WAS COMPLETED WITH THE ANOTHER TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25161543 ↗
• MalfunctionMay 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRIOR TO USE, THE GROUND DID NOT RESPOND. FRACTURE SUSPECTED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25090122 ↗
• MalfunctionMay 5, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT INTRA OP, USED 7.0MM NIM TUBE FOR NECK DISSECTION CASE. IT WAS FOUND TO BE DEFECTIVE AS THE BLUE PROBES WERE NOT BEING DETECTED BY THE NIM MACHINE, DESPITE MULTIPLE ATTEMPTS TO 1) UNPLUG AND REPLUG THE BLUE PROBES IN THE PATIENT INTERFACE, 2) TURNING ON AND OFF THE NIM MACHINE 3) SEVERAL PERSONNEL PLUGGING IN THE PROBES (2 CIRCULATING NURSES AND THE SURGEON). ANOTHER 7.0MM NIM TUBE WAS OPENED AND PATIENT WAS REINTUBATED USING THE NEW TUBE. NO HARM OCCURRED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084551 ↗
• InjuryApr 30, 2026Incorrect, Inadequate or Imprecise Result or Readings; 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 25039668 ↗
• MalfunctionApr 24, 2026Unintended Deflation

  IT WAS REPORTED THAT DURING INTRA-OP, THE NIM TRIVANTAGE EMG TUBE WAS LEAKING WHEN PLACED IN PATIENT. SURGERY WAS DELAYED BY LESS THAN 1 HOUR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24980028 ↗
• MalfunctionApr 20, 2026Break; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING A THYROID SURGERY, THE ENDOTRACHEAL TUBE SELF-CHECK COULD NOT BE PASSED AND THAT THE DEVICE SHOWED ABNORMAL WAVEFORM FLUCTUATION AND UNUSUAL NOISE. TESTING WITH A SIMULATOR INDICATED NO ISSUE WITH THE DEVICE. THE ENDOTRACHEAL TUBE COULD NOT BE REPLACED DURING THE SURGERY, SO THE RECURRENT LARYNGEAL NERVE MONITORING FUNCTION COULD NOT BE USED NORMALLY, THE PROCEDURE WAS EXTENDED FOR 15 MINUTES AND WAS COMPLETED USING THE REPORTED DEVICE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24922842 ↗
• MalfunctionApr 17, 2026Unintended Deflation

  IT WAS REPORTED THAT INTRA OP, THE CUFF OF EMG TUBE WAS LEAKED THREE TIMES IN THE PROCEDURE AND PROCEDURE WAS COMPLETED WITH THE BACK UP PRODUCT. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 24906772 ↗
• InjuryApr 11, 2026Unintended 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 24850120 ↗
• MalfunctionApr 3, 2026Difficult to Insert; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING INTRA-OP, THE TUBE WAS PLACED CORRECTLY INITIALLY, BUT IT WAS GETTING HORRIBLE INTERFERENCE TOWARDS THE MIDDLE OF THE CASE. THE TUBES SLIP VERY EASILY AND ANY TIME HAS TO PUSH ANYWHERE NEAR THE PATIENTS TRACHEA TO REACH POSTERIORLY. THE TUBE WAS DEFLATED AND RE-INSERTED. THE SURGERY WAS DELAYED BY 60 MINUTES. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. THE FIRST TIME RE-INSERTED THE TUBE, THE ISSUE SEEMED TO RESOLVE BUT THEN HAPPENED AGAIN. AFTER REINSERTED THE SECOND TIME, IT WAS BETTER BUT STILL VERY NOISY. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 24781939 ↗
• MalfunctionMar 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A THYROID SURGERY, AN EMG TUBE WAS PLANNED TO BE USED FOR NERVE MONITORING. NO ELECTROMYOGRAPHIC (EMG) SIGNAL WAS PRESENT THROUGHOUT THE PROCEDURE. EQUIPMENT AND INTERFACE BOX MALFUNCTION WERE RULED OUT, AND ADJUSTMENT OF THE EMG TUBE DEPTH WAS PERFORMED; HOWEVER, NO SIGNAL WAS OBTAINED AND PROCEDURE WAS COMPLETED WITHOUT USING A NERVE MONITORING EMG TUBE AND PRE-INFLATION INSPECTION OF THE CUFF REVEALED NO ABNORMALITIES; HOWEVER, NO ELECTROMYOGRAPHIC (EMG) SIGNALS WERE DETECTED THROUGHOUT THE PROCEDURE AND PROCEDURE WAS DELAYED 20 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24710346 ↗

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