NIM Trivantage® 8229738 (UDI 20643169782659)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20643169782659), received between Nov 3, 2017 and May 5, 2021 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2021Leak/Splash; Leak/Splash

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE TUBE HAD A LEAKING CATHETER BALLOON DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11775853 ↗
• MalfunctionDec 17, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT NERVE MONITORING ENDOTRACHEAL TUBE WAS NOT WORKING PROPERLY. PROBE DID NOT DETECT NERVE. THERE WAS NO HARM REPORTED EXCEPT FOR PATIENT INCONVENIENCE, PATIENT WAS SAFE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11025924 ↗
• MalfunctionSep 18, 2019Material Puncture/Hole; Material Puncture/Hole

  A HEALTH CARE PROVIDER REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THERE WAS A HOLE IN CUFF WHICH WAS NOTICED DURING THE PROCEDURE. THE TUBE WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9081431 ↗
• MalfunctionDec 28, 2018Use of Device Problem; Use of Device Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE ABOUT THE DYSFUNCTION OF DEVICE'S TUBING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8204496 ↗
• MalfunctionJun 19, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  ADDITIONAL INFORMATION INDICATED THAT NIM TUBE WAS INITIALLY USED DURING HEMITHYROIDECTOMY AND INTUBATION AND FIXATION WITHOUT ANY PROBLEMS. THE SURGEON INDICATED THERE WAS NO SIGNAL. REPOSITIONED THE TUBE BUT NO EFFECT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7612808 ↗
• InjuryNov 3, 2017Air Leak; Air Leak

  THE FACILITY REPORTED THAT PRIOR TO INTUBATING THE PATIENT FOR A TOTAL THYROIDECTOMY THE EMG CUFF AND TUBE WERE BOTH CHECKED FOR PATENCY; THEY BOTH WORKED AS EXPECTED. ABOUT 5 MINUTES AFTER INTUBATING THE PATIENT WITH THE TRIVANTAGE EMG TUBE, THE ANESTHESIOLOGIST OBSERVED THAT THE CUFF WAS SLOWLY LEAKING AIR. THE PATIENT WAS EXTUBATED AND REINTUBATED WITH A NEW TUBE TO COMPLETE THE PROCEDURE; THERE WAS NO PATIENT INJURY.

  Patient problems: Extubate

  MAUDE report 6999137 ↗

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-0696-2024 · Nov 7, 2023 · Open, Classified
  NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ID; d) 8229736, 6MM ID 3PK; e) 8229737, 7MM
• 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