NIM TriVantageRecalls & reported problems across all models

We found 18 models of NIM TriVantage by Medtronic Xomed, Inc. in the FDA's device registry (GUDID). Together they are named in 541 adverse event reports in the FDA's MAUDE database, received between Dec 8, 2016 and Sep 24, 2026 — classified as 55 injuries, 486 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (252 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

NIM TriVantage recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 8 of these models · Recall details · FDA record ↗

2. Dec 22, 2021Open, Classified

   There is potential for multiple issues due to a manufacturing nonconformity.

   Z-0743-2022 · Root cause: Process control · names 10 of these models · Recall details · FDA record ↗

Most reported NIM TriVantage problems

NIM TriVantage models

18 models, most reported first. Each model has its own page with its reports, recalls and device details.

• NIM TriVantage® 8229707

  STIMULATOR, NERVE
  2 recalls176 reports
• NIM Trivantage® 8229707

  STIMULATOR, NERVE
  1 recall142 reports
• NIM TriVantage® 8229706

  STIMULATOR, NERVE
  2 recalls78 reports
• NIM TriVantage® 8229708

  STIMULATOR, NERVE
  2 recalls50 reports
• NIM TriVantage® 8229737

  STIMULATOR, NERVE
  2 recalls31 reports
• NIM TriVantage® 8229738

  STIMULATOR, NERVE
  2 recalls8 reports
• NIM TriVantage® 8229736

  STIMULATOR, NERVE
  2 recalls2 reports
• NIM Trivantage® 8229706

  STIMULATOR, NERVE
  1 recall22 reports
• NIM TriVantage® 8229705

  STIMULATOR, NERVE
  1 recall0 reports
• NIM TriVantage® 8229709

  STIMULATOR, NERVE
  1 recall0 reports
• NIM TriVantage® 8229735

  STIMULATOR, NERVE
  1 recall0 reports
• NIM TriVantage® 8229739

  STIMULATOR, NERVE
  1 recall0 reports
• NIM Trivantage® 8229708

  STIMULATOR, NERVE
  13 reports
• NIM Trivantage® 8229738

  STIMULATOR, NERVE
  6 reports
• NIM TriVantage™ 8229707

  STIMULATOR, NERVE
  4 reports
• NIM TriVantage™ 8229708

  STIMULATOR, NERVE
  4 reports
• NIM Trivantage® 8229737

  STIMULATOR, NERVE
  4 reports
• NIM Trivantage® 8229736

  STIMULATOR, NERVE
  1 report

Recent NIM TriVantage adverse event reports

The 15 most recent reports across all models, 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 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 ↗
• 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, 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 ↗
• 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 21, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Additional information received, there was a procedural delay of 10 minutes for troubleshooting. There was no patient injury.

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

  MAUDE report 25884749 ↗
• 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 ↗
• 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 ↗
• 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 ↗

Other Medtronic Xomed, Inc. products

• NIM Vital9 models · 1,696 reports · 4 recalls
• NIM-Response13 models · 974 reports
• Indigo6 models · 916 reports
• StraightShot6 models · 546 reports
• NIM15 models · 410 reports · 2 recalls
• ViSAO16 models · 412 reports
• XPS Straightshot2 models · 356 reports
• RAD29 models · 183 reports · 1 recall