NIM Trivantage® 8229737 (UDI 20643169782642)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20643169782642), received between Nov 6, 2018 and Jul 2, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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.

• MalfunctionJul 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT DURING A PROCEDURE FOR THYROIDECTOMY, THE LEFT AND RIGHT ELECTRODE FOR THE TRUE VOCAL CORDS WAS MARKED X ON THE MONITOR SET UP, WHILE PROPERLY PLACED, - NO CHECK MARKS, DESPITE CHANGING INTERFACE AND MONITOR. THE ENDOTRACHEAL TUBE HAD TO CHANGE INTRAOPERATIVELY. THE PATIENT DID NOT HAVE ANY INJURIES FROM THIS PROBLEM. THE PATIENTS NERVE WAS INTACT POSTOPERATIVELY. THE CASE WAS INTERRUPTED/DELAYED FOR ABOUT 25 MINUTES WHILE WE WERE TROUBLE SHOOTING AND REINTUBATING/EXCHANGING THE ENDOTRACHEAL TUBE. THERE WAS A RISK OF LOSING THE AIRWAY WHEN EXCHANGING THE ENDOTRACHEAL TUBE. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22381393 ↗
• InjuryApr 6, 2020Leak/Splash; Leak/Splash

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE ANAESTHETIST HAD A PROBLEM WITH THE TUBE AFTER INTUBATION DURING A PARATHYROIDECTOMY PROCEDURE. SHE SAID THE TUBE WAS LEAKING AIR AND SHE WAS ALSO NOT HAPPY WITH THE WAY THE BALLOON INFLATED. SHE HAD TO INTUBATE AGAIN WITH 7.0MM TUBE AND THEN SHE WAS SATISFIED. THERE WAS A 40-MINUTES DELAY IN THE PROCEDURE AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. ON FOLLOW-UP, IT WAS REPORTED THAT THE LEAK WAS EVIDENT WHEN TRYING TO INFLATE THE CUFF TO ESTABLISH THE AIRWAY DURING THE INTUBATION PROCESS. IT WAS NOTED THAT IT WAS THE INITIAL USE OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 9928412 ↗
• InjuryJun 11, 2019Material Twisted/Bent; Material Twisted/Bent

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT DURING A THYROID SURGERY, AN ACT FOR WHICH THE ANESTHETIST DOES NOT HAVE ACCESS TO THE PATIENT'S HEAD, THE PATIENT DESATURATED (SAT O2 AT 70%, PET CO2>60MMHG) AND THE ANESTHETIST CANNOT VENTILATE IT. INTERVENTION INTERRUPTED. SURGICAL FIELDS REMOVED TO ACCESS THE UPPER AIRWAYS. THE PROBE [EMG TUBE] IS IN PLACE BUT A DOUBLE PLICATION (FOLD) IS NOTICED, THAT SUBSEQUENTLY RESULTED IN THE PROBE [EMG TUBE] REPLACED BY AN ARMORED NIM PROBE. RE-INTUBATION OF THE PATIENT INTRAOPERATIVELY, OUTSIDE THE STANDARD PROCEDURE AND UNDER HAZARDOUS CONDITIONS.

  Patient problems: Extubate; Hypoxia; Low Oxygen Saturation

  MAUDE report 8687325 ↗
• MalfunctionNov 6, 2018Deflation Problem; Deflation Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE CUFF OF THE DEVICE COULD NOT BE DEFLATED COMPLETELY AND THERE WAS 10CC LEFT. THE PATIENT WAS ALIVE AND THERE WAS NO ANY PATIENT SYMPTOMS. THE CUFF WAS NOT DEFLATING AND IT WAS DISCOVERED AFTER THE THYROIDECTOMY SURGERY. A BACK-UP DEVICE WAS NOT NEEDED. ON EXTUBATION, THE DISTAL BALLOON STILL CONTAIN AIR (10CC) AFTER EMPTYING. THE EXTUBATION OF THE SYSTEM WAS MORE DIFFICULT. THERE WAS A POTENTIAL RISK OF INJURY OR OBSTRUCTION DURING EXTUBATION, BUT THERE WAS NO PATIENT CONSEQUENCE IN THIS CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8041138 ↗

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