NIM TriVantage™ 8229707Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169060791), received between Dec 8, 2016 and Feb 28, 2020 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2020Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION RECEIVED STATING THAT AFTER INTUBATION, THE ANESTHESIOLOGIST FOUND THE CUFF WAS DEFLATED GRADUALLY, SO THEY REPLACED THE TUBE WITH A BACK-UP. BUT THE SURGEON HAVEN¿T STARTED TO DO THYROIDECTOMY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9768193 ↗
• InjuryMar 10, 2017Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A SURGERY, THE ENDOTRACHEAL EMG TUBE HAD GOTTEN A HOLE IN IT AND HAD TO BE REPLACED. FOLLOW-UP INFORMATION INDICATES THAT THERE WAS NO PATIENT INJURY. HOWEVER, THE TUBE WAS REMOVED AND REPLACED.

  Patient problems: Extubate

  MAUDE report 6395257 ↗
• InjuryMar 10, 2017Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A RIGHT THYROID LOBECTOMY, THE ENDOTRACHEAL EMG TUBE HAD GOTTEN A HOLE IN IT AND HAD TO BE REPLACED. FOLLOW-UP INFORMATION PROVIDED INDICATES THAT THERE WAS NO PATIENT INJURY. HOWEVER, WHEN THE INITIAL INCISION WAS MADE BY THE SURGEON, ¿GURGLING¿ WAS HEARD BY THE ANESTHESIOLOGIST. AN ATTEMPT WAS MADE TO REINFLATE THE BALLOON (CUFF) WITHOUT SUCCESS. IT WOULD NOT HOLD AIR. THEREFORE, THE TUBE WAS REMOVED AND REPLACED WITH A NEW TUBE. THE CASE WAS FINISHED WITHOUT FURTHER INCIDENT.

  Patient problems: Extubate

  MAUDE report 6395149 ↗
• MalfunctionDec 8, 2016False Negative Result; False Negative Result

  IT WAS REPORTED THAT DURING A THYROIDECTOMY PROCEDURE THE EMG TUBE AND PROBE WERE NOT DETECTING NERVES. THIS PROBLEM WAS NOTICED AT THE BEGINNING OF THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6156463 ↗

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