TruDi Probe TDP0005Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031464193), received between Nov 6, 2020 and Apr 30, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Incorrect Interpretation of Signal” (6 reports).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2025Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THERE WAS SIGNIFICANT INACCURACY ON THE TRUDI NAVIGATION SYSTEM DURING A PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) IN THE OPERATING ROOM (OR). DURING INITIAL REGISTRATION THE TRUDI PROBE, 0, 5IN (TDP0005, 230926A-PC) DID NOT INITIALLY RECOGNIZE THE FIDUCIAL POINTS, AND WHILE TRACING THE REGISTRATION PROBE GREEN LINES WERE NO LONGER APPEARING GREEN. TO TROUBLESHOOT, THE CALLER RESTARTED THE SYSTEM, THIS RESOLVED THE REGISTRATION ISSUE, THE PROBE WAS WORKING. THEN, MID-CASE THE ACCURACY OF THE INSTRUMENTS WAS "SIGNIFICANTLY OFF." THEY TRIED USING A NEW SUCTION, A NEW TRUDI SHAVER BLADE - STRAIGHT, DOUBLE SERRATED, 4.0MM X 110MM (TSB4STR, 250107F-PC), A NEW PROBE, THEY REREGISTERED, TRIED USING A NEW DISPOSABLE PATIENT TRACKER, ALL WITHOUT RESOLUTION. THE SUCTION DEVICE USED WAS GREATER THAN 30 USES, OUT OF WARRANTY BUT THIS DID NOT EXPLAIN THE OTHER ACCURACY ISSUES. THE CASE WAS CONTINUED WITHOUT RESOLUTION. THERE WAS NO ALLEGATION THAT A DEATH OR SERIOUS INJURY OCCURRED DUE TO THE USE OF THE PRODUCT. THERE WAS NO REPORT OF THE PATIENT REQUIRING MEDICAL INTERVENTION. NON ACCLARENT DEVICES WERE USED. ADDITIONAL EVENT INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21936789 ↗
• MalfunctionJun 24, 2024Use of Device Problem; Use of Device Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IN-OFFICE PRIMARY BALLOON SINUPLASTY (BSP) PROCEDURE, WHEN THE ENTC (ENT CONSULTANT) WAS CONNECTING THE CORDS TO THE INSTRUMENT HUB, THE ENTC ACCIDENTALLY PULLED THE DISPOSABLE TRUDI PROBE 0-DEGREE, 5IN (TDP0005 / 240408A-PC) OFF THE FIELD AND THE TRUDI PROBE FELL TO THE GROUND. THE TRUDI PROBE WAS REPLACED AND THE PROCEDURE CONTINUED. A REPLACEMENT DEVICE WAS REQUESTED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601956 ↗
• InjuryMar 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A BALLOON SINUPLASTY (BSP) PROCEDURE, THE PATIENT SUSTAINED AN INJURY TO HER CAROTID ARTERY THAT RESULTED IN HER SUFFERING A CATASTROPHIC STROKE. THE REPORTED DEVICES USED DURING THE PROCEDURE WERE: A RELIEVE TRACT BALLOON (RT1640A / 211202A-PC), TWO 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSN), ONE FROM LOT 220419A-PC AND ONE FROM LOT 220504A-PC, A DISPOSABLE TRUDI PROBE 0-DEGREE, 5IN (TDP0005 / 210201B-PC), AN ACCLARENT BALLOON INFLATION DEVICE (BID30 / 96375250), AND A TRUDI NAV CABLE (TDNC001 / 211206C-PC) AND THE TRUDI NAVIGATION SYSTEM. IT IS REPORTED THAT THE PATIENT BELIEVED THAT THE ACCLARENT NAVIGATION BALLOON DILATION SYSTEM AND ITS COMPONENT PARTS, INCLUDING ANY AI (ARTIFICIAL INTELLIGENCE SOFTWARE) MAY HAVE MALFUNCTIONED AND FAILED TO PERFORM AS INTENDED DURING THE PROCEDURE, AND THAT AS A RESULT, THE PATIENT¿S CAROTID ARTERY WAS INJURED.

  Patient problems: Perforation of Vessels; Stroke/CVA

  MAUDE report 18962843 ↗
• MalfunctionFeb 12, 2024Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A HYBRID PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE IN THE OPERATING ROOM (OR), WHILE NAVIGATING A TRUDI PROBE, 0, 5IN (TDP0005, LOT UNKNOWN, SERIAL NUMBER (B)(6) INACCURATE BY DISPLAYING THE DEVICE WAS FARTHER LEFT AND INFERIOR TO WHERE IT WAS LOCATED. CALLER REPLACED THE DEVICE WITH A SECOND TRUDI PROBE, 0, 5IN (TDP0005, LOT UNKNOWN, SERIAL NUMBER (B)(6), WITH NO RESOLUTION. CALLER THEN SWITCHED TO THE SPIN PLUS BALLOON TO CONTINUE THE PROCEDURE. NO NON ACCLARENT DEVICES WERE USED. THE ACCLARENT DEVICE(S) DID NOT FUNCTION AS EXPECTED. THERE WAS NO ALLEGATION THAT A DEATH OR SERIOUS INJURY OCCURRED DUE TO THE USE OF THE PRODUCT. THERE WAS NO REPORT OF THE PATIENT REQUIRING MEDICAL INTERVENTION AS A RESULT THE ALLEGED PRODUCT ISSUE. ADDITIONAL EVENT INFORMATION RECEIVED ON 18-JAN-2024 INDICATED THAT THE PATIENT TRACKER WAS NOT MOVED NOR WAS THE PATIENT TRACKER CABLE UNDER TENSION IN RELATION TO THE EVENT. ONLY ONE CT SCAN WAS ATTEMPTED TO BE USED WITH ONE DEVICE. THE AXIAL COMPUTED TOMOGRAPHY (CT) WAS USED AS THE PRIMARY IMAGE. NO FERROMAGNETIC MATERIAL WAS PLACED WITHIN THE TRUDI ZONE. THE EMITTER PAS DID NOT MOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18687285 ↗
• MalfunctionFeb 12, 2024Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A HYBRID PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE IN THE OPERATING ROOM (OR), WHILE NAVIGATING A TRUDI PROBE, 0, 5IN (TDP0005, LOT UNKNOWN, SERIAL NUMBER (B)(6)) INACCURATE BY DISPLAYING THE DEVICE WAS FARTHER LEFT AND INFERIOR TO WHERE IT WAS LOCATED. CALLER REPLACED THE DEVICE WITH A SECOND TRUDI PROBE, 0, 5IN (TDP0005, LOT UNKNOWN, SERIAL NUMBER (B)(6)), WITH NO RESOLUTION. CALLER THEN SWITCHED TO THE SPIN PLUS BALLOON TO CONTINUE THE PROCEDURE. NO NON ACCLARENT DEVICES WERE USED. THE ACCLARENT DEVICE(S) DID NOT FUNCTION AS EXPECTED. THERE WAS NO ALLEGATION THAT A DEATH OR SERIOUS INJURY OCCURRED DUE TO THE USE OF THE PRODUCT. THERE WAS NO REPORT OF THE PATIENT REQUIRING MEDICAL INTERVENTION AS A RESULT THE ALLEGED PRODUCT ISSUE. ADDITIONAL EVENT INFORMATION RECEIVED ON 18-JAN-2024 INDICATED THAT THE PATIENT TRACKER WAS NOT MOVED NOR WAS THE PATIENT TRACKER CABLE UNDER TENSION IN RELATION TO THE EVENT. ONLY ONE CT SCAN WAS ATTEMPTED TO BE USED WITH ONE DEVICE. THE AXIAL COMPUTED TOMOGRAPHY (CT) WAS USED AS THE PRIMARY IMAGE. NO FERROMAGNETIC MATERIAL WAS PLACED WITHIN THE TRUDI ZONE. THE EMITTER PAS DID NOT MOV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18687272 ↗
• MalfunctionDec 14, 2023Material Integrity Problem; Material Integrity Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, THE DISPOSABLE TRUDI PROBE 0-DEGREE, 5IN (TDP0005 / LOT# UNKNOWN) BROKE AT THE SHAFT WHILE THE SURGEON WAS PALPITATING TISSUE. THE TRUDI PROBE WAS REPLACED AND THE ISSUE WAS RESOLVED AND THE PROCEDURE RESUMED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18332557 ↗
• MalfunctionApr 14, 2023Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE ON (B)(6) 2023, THE FOLLOWING DEVICES WERE USED: A 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / LOT# UNKNOWN), A 70° TRUDI NAV SUCTION DEVICE (TDNS070Z / LOT# UNKNOWN), AND A TRUDI PROBE 0-DEGREE, 5IN (TDP0005 / LOT# UNKNOWN). IT WAS REPORTED THAT THE PATIENT WAS REGISTERED AND WHEN THEY CHECKED THE ACCURACY OF THE VISUAL WITH ONE OF THE SUCTION DEVICES ON THE BRIDE OF THE NOSE, IT WAS OFF. WHEN THEY WENT INTO THE MAXILLARY SINUS, THE SUCTION WAS AT THE BACK WALL OF THE MAXILLARY SINUS, BUT IT SHOWED IT WAS A CENTIMETER OFF. TO TROUBLESHOOT, THE ACCLARENT REPRESENTATIVE RE-REGISTERED WITHOUT RESOLUTION. DIFFERENT POINTS OF REGISTRATION WERE ATTEMPTED WITHOUT RESOLUTION. THE ACCLARENT REPRESENTATIVE CHECKED WITH THE TRUDI PROBE 0-DEGREE, 5IN (TDP0005 / LOT# UNKNOWN) AND THE VISUAL WAS STILL INACCURATE. THE PHYSICIAN DECIDED TO CONTINUE WITH THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT AND NO MEDICAL INTERVENTION WAS REQUIRED. IT WAS REPORTED THAT THE TRUDI SOFTWARE WAS V2.3 (FULL VERSION COULD NOT BE VERIFIED). THE INSTRUMENTS USED DURING TROUBLESHOO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16747862 ↗
• MalfunctionDec 14, 2022Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY PROCEDURE, THE TRUDI PROBE 0-DEGREE, 5IN (TDP0005 / 210310A-PC) WAS OFF IN ACCURACY BY ABOUT 4MM ON THE TRUDI NAVIGATION SYSTEM. THE REGISTRATION PROBE WAS SHOWING ACCURATE; THE REGISTRATION PROBE WAS REPLACED WITHOUT RESOLUTION. THE TRUDI NAV SUCTION DEVICE WAS ALSO REPLACED AND THE TRUDI NAVIGATION SYSTEM SHOWED ¿CLOSE TO ACCURATE.¿ THE TRUDI PROBE WAS REPLACED AND THE ISSUE RESOLVED; THE PROCEDURE CONTINUED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT. ON (B)(6) 2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT WHEN THE REPORTED ACCURACY ISSUE WAS OBSERVED, THE ICON ON THE TRUDI NAVIGATION SYSTEM WAS GREEN. THERE WAS NO ERROR MESSAGE ON THE TRUDI NAV MONITOR FOR THE DEVICE. THE INFORMATION REPORTED THAT THE DEVICE WAS PLUGGED IN AFTER REGISTRATION. THE PATIENT TRACKER DID NOT MOVE; THE PATIENT TRACER CABLE WAS NOT UNDER TENSION IN RELATION TO THE REPORTED EVENT. AXIAL COMPUTED TOMOGRAPHY (CT) IMAGE WAS USED AS THE PRIMARY IMAGE. NOT MORE THAN ONE CT SCAN WAS ATTEMPTED TO BE USED WITH ONE DEVICE. THE INFORMATION STATED THAT THE INACCURACY ISSUE WAS DE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15982639 ↗
• MalfunctionJul 19, 2022Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, THE TRUDI PROBE 0-DEGREE, 5IN (TDP0005 / LOT# UNKNOWN) WAS ¿OFF CALIBRATION.¿ AFTER REGISTERING THE PATIENT, THE TRUDI PROBE ACCURACY APPEARED TO BE OFF BY ABOUT 1CM. THE PATIENT WAS RE-REGISTERED WITHOUT RESOLUTION. IT WAS REPORTED THAT THE ¿JUST THE TRUDI PROBE ACCURACY WAS OFF.¿ THE PHYSICIAN DECLINED ANY FURTHER TROUBLESHOOTING AND THE PROCEDURE CONTINUED WITH THE ISSUE PERSISTING. IT WAS NOTED THAT THIS IS A RECURRING ISSUE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ON 29-JUN-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE REGISTRATION PROBE WAS USED TO CONFIRM THE ACCURACY OF THE SYSTEM AND THE REGISTRATION ON ALL AREAS OF THE FACE AS PER THE INSTRUCTIONS FOR USE (IFU). INACCURACY WAS NOTICED IMMEDIATELY WHEN THE SURGEON STARTED TO NAVIGATE THE DISPOSABLE PROBE. THEY FIRST NOTICED IT INSIDE THE PATIENT AND THEN CONFIRMED THAT IT WAS IN ACCURATE ON THE PATIENT FACE AS WELL. THE INFORMATION STATED THAT THEY DID NOT CHECK INTRANASAL POINT OR ACCURACY AS THEY DID NOT NEED TO SEND IT WAS VERY OBVIOUSLY NOT ACCURATE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15060892 ↗
• MalfunctionJun 21, 2021Material Separation; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE 0-DEGREE TRUDI PROBE (TDP0005 / LOT# UNKNOWN) WAS USED WITH THE ACCLARENT PIVOT NAVIGATION BALLOON DILATION SYSTEM (PVT0616N / LOT# UNKNOWN), THE SHAFT OF THE TRUDI PROBE CAME APART AND SEPARATED (THE DISTAL END SEPARATED FROM THE PROXIMAL PORTION THAT CONNECT TO THE HANDLE. THE GUIDEWIRE ON THE PIVOT NAVIGATION BALLOON ALSO BECAME SLIGHTLY KINKED. THE CASE WAS REPORTEDLY COMPLETED WITHOUT ANY PATIENT ADVERSE EVENT OR COMPLICATION. ON 10 JUNE 2021, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PROCEDURE WAS A PRIMARY BALLOON SINUPLASTY (BSP) PROCEDURE. THE SHAFT OF THE TRUDI PROBE CAME APART AND SEPARATED AS REPORTED DURING THE TREATMENT OF THE MAXILLARY SINUS. NO PIECES FROM THE SEPARATED SHAFT FELL INTO THE PATIENT¿S ANATOMY. THERE WAS NO INJURY TO THE NASAL NOR SINUS TISSUE FROM THE REPORTED ISSUE WITH THE TRUDI PROBE SHAFT. THE TRUDI PROBE HAD BEEN USED ONCE DURING THIS PROCEDURE WHEN THE ISSUE WITH THE SHAFT WAS ENCOUNTERED. THERE WAS NO DIFFICULTY IN ACCESSING THE SINUS WITH THE PIVOT BALLOON CATHETER; IT HAD BEEN USED IN OTHER SINUSES DURING THE PROCEDURE PRIOR TO THE GUIDEWIRE BECOMIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12034569 ↗
• MalfunctionNov 6, 2020Break; Break

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IN-OFFICE PRIMARY BALLOON SINUPLASTY PROCEDURE, THE TRUDI PROBE (TDP0005 / LOT#: UNKNOWN) FOR THE TRUDI NAV SYSTEM BROKE; THIS OCCURRED WHILE USING THE BENDING TOOL. THERE WAS NO DIFFICULTY IN REMOVING THE PROBE FROM THE PATIENT¿S BODY. THE BROKEN PROBE WAS REPLACED, AND THE PROCEDURE WAS RESUMED TO COMPLETION. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10805062 ↗