NIM TriVantage™ 8229708Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169060807), received between Jan 13, 2017 and Jan 29, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

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.

• MalfunctionJan 29, 2019Leak/Splash; Leak/Splash

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE DEVICE LEAKED WHEN STARTED TO USE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8286624 ↗
• InjurySep 18, 2018Material Puncture/Hole; Material Puncture/Hole

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE DEVICE HAD A PIN HOLE IN THE BALLOON DURING A RIGHT THYROID LOBECTOMY PROCEDURE. THE DEFECT WAS DETECTED WHEN THE PATIENT WAS INTUBATED, SO THE TUBE WAS REMOVED AND THE PATIENT WAS RE-INTUBATED WITH A NEW TUBE. THE PATIENT SUFFERED NO INJURIES AND THE PROCEDURE WAS ONLY BRIEFLY DELAYED. THE PATIENT WAS REINTUBATED TO PREVENT SERIOUS INJURY OR DEATH. THE HCP ALSO NOTED THAT IT WAS THE FIRST TIME THE TUBE WAS USED.

  Patient problems: Extubate

  MAUDE report 7886732 ↗
• MalfunctionJun 19, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN INDICATES THAT THERE WAS NO WAVEFORM, THE LINE WAS FLAT. THE SYSTEM RECOGNIZED THE ELECTRODES. BOTH SIDES OF THE EMG TUBE WERE NOT RESPONDING. REINTUBATION WAS NOT PERFORMED. THE USER COULD VISUALLY CONFIRM THAT THE MUSCLE MOVED, HOWEVER THERE WAS NO RESPONSE FROM THE SYSTEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6651253 ↗
• MalfunctionJan 13, 2017False Negative Result; False Negative Result

  IT WAS REPORTED THAT THE TRIVANTAGE EMG TUBE WAS NOT RESPONDING NORMALLY. THE PHYSICIAN OPTED TO CONTINUE THE PROCEDURE WITH THE REPORTED PRODUCT. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO USE THE NIM AS MUCH AS HE/SHE COULD. DISCONNECTION AND/OR FRACTURE WAS SUSPECTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6249326 ↗

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