NIM TriVantage® 8229736 (UDI 20763000041513)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20763000041513), received between Jul 16, 2025 and Jul 21, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 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 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 ↗

2. Dec 22, 2021Open, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 16, 2025Signal Artifact/Noise; Incorrect, Inadequate or Imprecise Result or Readings; Signal Artifact/Noise; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THYROIDECTOMY PROCEDURE, THERE WAS EXCESS NOISE HAPPENING THROUGHOUT NIM VITAL CASE USING SIZE 6 TRIVANTAGE TUBE. NIM VITAL SOFTWARE HAS ALREADY BEEN UPDATED. PASSED ELECTRODE CHECK AT BEGINNING OF CASE AND THEN EXCESS NOISE STARTED TO HAPPEN WITHIN THE FIRST 30 MIN OF CASE. WENT THROUGH ALL TROUBLESHOOTING. PATIENT WAS NOT LIGHT, BITE BLOCK WAS PLACED, MACHINE PLUGGED INTO SEPARATE OUTLET, INCREASED THRESHOLD TO 150, RESTARTED MACHINE, SWITCHED OUT PI BOX. WHEN PERFORMING ELECTRODE CHECK VOCALIS 2 IS TURNING RED THEN GREEN THEN BACK TO RED (CONSTANTLY CIRCLING AND NEVER STAYING GREEN). PHYSICIAN WAS EXTREMELY UPSET AS THIS WAS A HUGE DISTRACTION DURING THE CASE. STAFF WAS ALSO UPSET AND FRUSTRATED WITH EXCESS NOISE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22517340 ↗

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