TruDi NAV Cable TDNC001Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031245853), received between Feb 15, 2023 and Apr 24, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Incorrect Interpretation of Signal” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K180948); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2024Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IN-OFFICE HYBRID BALLOON SINUPLASTY (BSP) PROCEDURE WITH SHAVER, THE PHYSICIAN FELT THAT THERE WAS A VARIETY OF INACCURACIES BETWEEN THE DIFFERENT INSTRUMENTS THAT WERE USED. THE INSTRUMENTS USED WERE THE FOLLOWING: A 4.0MM ¿ 15° TRUDI NAVIGATION SHAVER BLADE (TSB415 / 240117C-PC), A 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / 2308140), A 70° TRUDI NAV SUCTION DEVICE (TDNS070Z / 2309057), A 90° TRUDI NAV SUCTION DEVICE (TDNS090Z / 2312269), AN ACCLARENT PIVOT NAVIGATION BALLOON DILATION SYSTEM (PVT0616N / 82284217), AND A TRUDI NAV CABLE (TDNC001 / 240304D-PC) THAT WAS USED FOR THE SUCTIONS. HOW MUCH INACCURACY WAS OBSERVED / PRESENT COULD NOT BE CONFIRMED. THE PROCEDURE REPORTEDLY CONTINUED WITHOUT ANY TROUBLESHOOTING. THE SOFTWARE VALUE TO BE V2.3.2.3, BUT THE CALLER DID NOT HAVE THE FULL VERSION. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. NONE OF THE COMPLAINT PRODUCTS ARE AVAILABLE FOR RETURN. ON 24-APR-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PHYSICIAN¿S OFFICE STAFF MEMBER REGISTERED THE CASE. HOW THE INACCURACY WAS DETERMINED COULD NOT BE CONFIRMED. THE INACCURACY WAS FIRST NOTICED WHEN THE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19177536 ↗
• InjuryMar 22, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; 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 RELIEVA 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 18963032 ↗
• MalfunctionFeb 15, 2023Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE ON (B)(6) 2023, IT WAS REPORTED THAT THE TRUDI NAV SYSTEM (S/N: (B)(4)) BECAME INACCURATE HALFWAY THROUGH THE PROCEDURE. IT WAS REPORTED THAT THE FURTHER POSTERIOR THE CASE PROGRESSES IN THE PATIENT, THE MORE INACCURATE IT BECAME. THE DEVICES WERE DISCONNECTED AND RECONNECTED BUT THE ISSUE CONTINUED. THE TRUDI NAV CABLE (TDNC001 / 220914B-PC) WAS AFFECTED BY THE SAME ISSUE WITH ACCURACY. THE PROCEDURE CONTINUED AND WAS REPORTED AS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE PATIENT IMPACT. ON 18-JAN-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE END USER DID CONFIRM ACCURACY USING THE REGISTRATION PROBE AFTER THE REGISTRATION PROCESS WAS COMPLETED BOTH TIMES THE PATIENT WAS REGISTERED. ACCURACY WAS CONFIRMED WITH KNOWN LANDMARKS IN ENDOSCOPIC VISUALIZATION INSIDE THE NASAL CAVITY, THE INFORMATION INDICATED THAT, ¿THROUGHOUT THE SURGERY WE MADE CHECKS OF ACCURACY WITH THE ENDOSCOPE AND NAVIGATED DEVICES.¿ ACCURACY WAS NOTICED THROUGHOUT THE CASE WHEN THE PHYSICIAN ENCOUNTERED KNOWN LANDMARKS AND THE NAVIGATION WAS NOT LINING UP. MOST NOTABL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16383620 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K180948. One submission often covers many models, so check the product and lot details in each record.

• Z-2507-2024 · Jul 9, 2024 · Open, Classified
  TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during surgical procedures in E
• Z-0415-2022 · Nov 12, 2021 · Open, Classified
  TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
• Z-0824-2020 · Mar 6, 2019 · Terminated
  TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877
• Z-0826-2020 · Mar 6, 2019 · Terminated
  TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
• Z-0825-2020 · Mar 6, 2019 · Terminated
  TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884