TruDi™ Navigation System 1Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10846835018639), received between Aug 2, 2024 and Sep 18, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Incorrect Interpretation of Signal” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Sep 21, 2023Open, Classified

   When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during surgical procedures of the Ear Nose and Throat (ENT) and ENT skull base surgery, which may cause delayed/prolonged surgery, cerebrospinal fluid leak, visual impairment, or skull base structural damage.

   Z-0127-2024 · Root cause: Software Design Change · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Incorrect Interpretation of Signal

  It was reported that during Sinus Functional Endoscopic Sinus Surgery (FESS) the surgeon was not willing to proceed with use of image guidance/TruDi Navigation System (FG-2000-00) due to accuracy issues following registration; image did not align with anatomy after multiple registrations. Patient was re-registered (three 3) times and was reportedly still inaccurate near right and left orbits . The "surgeon then grabbed MDT machine and TruDi machine was not used for procedure". It was reported that there was no delay in procedure and no patient injury occurred.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819195 ↗
• MalfunctionSep 14, 2026Incorrect Interpretation of Signal

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50763388 ↗
• MalfunctionSep 14, 2026Incorrect Interpretation of Signal

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50758287 ↗
• MalfunctionSep 14, 2026Incorrect Interpretation of Signal

  It was reported that during primary Functional Endoscopic Sinus Surgery (FESS) to treat all sinuses, the accuracy of the TruDi Navigation System (FG-2000-00) was off by 6+ mm. Staff reported "accuracy showing us that we were in the orbit when that was not the case." It was reported that inaccuracy was determined by knowing where the suction and navigation devices were in the patient verses what the TruDi was showing. When the issue was observed, the icon of the device appeared green on the TruDi. It was reported that there was an extra seven (7) minutes in surgery time due to having to re-register the patient. No patient injury was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50757266 ↗
• MalfunctionFeb 24, 2026Device Sensing Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24428897 ↗
• MalfunctionJan 14, 2026Incorrect Interpretation of Signal

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068366 ↗
• MalfunctionJan 12, 2026Electromagnetic Interference

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24033379 ↗
• MalfunctionDec 4, 2025Failure to Read Input Signal; Failure to Read Input Signal

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23723691 ↗
• MalfunctionJul 23, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE TRUDI NAVIGATION SYSTEM (FG-2000-00) DISPLAYED A RED ICON AND ERROR CODE 2100 WHEN THE EMITTER PAD WAS CONNECTED. IT WAS REPORTED THAT THERE WAS A 30-MINUTE SURGICAL DELAY. NO PATIENT INJURY OR DEATH WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576002 ↗
• MalfunctionJul 14, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT BEFORE A CASE BEGAN, THE FG-2000-00 TRUDI NAVIGATION SYSTEM WAS UNABLE TO BE USED DUE TO THE CONSOLE NOT POWERING ON. IT WAS REPORTED THAT UPON TURNING ON THE TRUDI SYSTEM, IMMEDIATELY THE ERROR CODE 1305 (LOCATION SERVER STOPPED WORKING) WAS DISPLAYED WITH THE CONSOLE; READING LOCATION SERVER STOPPED. THE INTEGRA SALES REPRESENTATIVE FIRST TRIED RESTARTING THE TRUDI, YET THE ISSUE PERSISTED. THE REPRESENTATIVE THEN TRIED FULLY SHUTTING THE TRUDI DOWN AND TURNING IT BACK ON, YET THE ISSUE PERSISTED. THE REP NOTICED THAT NOT ONLY DID THE CONSOLE NOT TURN ON, BUT EVEN ON THE SETTINGS ICON IT WASN'T ABLE TO BE POWERED ON; THEREFORE, THE BACK OF THE TRUDI WAS OPENED TO LOOK AT THE POWER CABLES. THE INTEGRA REP CHECKED THAT ALL NYDAC CABLES WERE SAT RIGHT, THE POWER CORD IN THE CONSOLE WAS SECURE AND THE 4TH GREY SS WIRE WAS SECURE. THE REP TRIED DIFFERENT PLUGS ON THE TRANSFORMER, YET THE ISSUE PERSISTED. THE REP THEN TRIED REPLACING THE POWER BOX OF THE CONSOLE WITH AN ALTERNATIVE POWER BOX FROM ANOTHER TRUDI THAT WAS KNOWN TO BE WORKING; HOWEVER, THE ISSUE PERSISTED. THE REP TRIED UNPLUGGING THE INSTRUMENT HUB AND EMITTER PAD AND RESTARTING, YET THE ISSUE PERSIST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22503069 ↗
• MalfunctionJun 30, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE POWER UNIT OF THE TRUDI NAVIGATION SYSTEM (FG-2000-00) OVERHEATED DURING A DEMONSTRATION CASE. THE REPORTER STATED THAT AFTER TWO HOURS, THEY "TOUCHED THE CONSOLE AND NOTICED IT WAS EXTREMELY HOT". ADDITIONALLY, THE REPORTER NOTICED AN ERROR MESSAGE 2100 - OVERHEATING. THERE WAS NO PATIENT INVOLVEMENT AND NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22367376 ↗
• MalfunctionMay 29, 2025Intermittent Communication Failure; Intermittent Communication Failure

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22107660 ↗
• MalfunctionMay 29, 2025Smoking; Smoking

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22105351 ↗
• InjuryAug 2, 2024Image Orientation Incorrect; Patient Device Interaction Problem; Image Orientation Incorrect; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BALLOON SINUPLASYTY, MAXILLARY ANTROSTOMY, AND ETHMOIDECTOMY AND THE PATIENT EXPERIENCED CEREBROSPINAL FLUID LEAKAGE THAT REQUIRED SURGICAL INTERVENTION. IT WAS REPORTED THAT THE RELIEVE SPINPLUS BALLOON WIRE BECAME KINKED DURING THE PROCEDURE, TOWARDS THE DISTAL END. THE RELIEVE SPINPLUS BALLOON WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. LATER IN THE PROCEDURE, THE TRUDI NAVIGATION SYSTEM ACCURACY WAS OFF BY ABOUT 5MM, FOR ALL NAVIGATED DEVICES. THE PATIENT WAS RE-REGISTERED WITHOUT RESOLUTION. TESTING TWO DIFFERENT TRUDI NAV SUCTION DEVICES WAS ATTEMPTED, BUT THE ISSUE STILL PERSISTED. A NEW TRUDI CURETTE WAS OPENED WITHOUT RESOLUTION. THE PROCEDURE CONTINUED WITH THE ACCURACY ISSUE PERSISTING. ALSO DURING THE PROCEDURE, IT WAS NOTICED THAT THE PATIENT'S NASAL CAVITY WAS LEAKING CEREBROSPINAL FLUID (CSF). THE MEDICAL INTERVENTION PROVIDED TO THE PATIENT WAS A GRAFT OFF THE EAR, IN ORDER TO PACK THE CSF LEAK. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THIS WAS A PRIMARY SURGERY IN THE OPERATING ROOM. ADDITIONAL INFORMATION WAS RECEIVED WHEREIN THE CUSTOMER CONFIRMED ACCURACY USING THE REGISTRATION PROBE AFT

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 19894309 ↗