ILLUMISITE ILS-0900-KTRecalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 10884521723825), received between Mar 5, 2021 and Sep 23, 2026 — classified as 20 injuries, 69 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (64 reports).

1 other recall cover devices cleared under the same FDA submission (K191394); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 89 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Device Displays Incorrect Message

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50874275 ↗
• MalfunctionSep 16, 2026Connection Problem

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50794376 ↗
• MalfunctionSep 3, 2026Patient Data Problem

  It was reported that during the procedure, the monitor displayed no sensing volume, and could not perform registration. The physician was able to complete the superDimension portion of the case by using a new catheter. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50595780 ↗
• MalfunctionMay 29, 2026Device Displays Incorrect Message

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE PHYSICIAN NAVIGATED TO THE LUNG NODULE AND COMPLETED A FLUORO SWEEP, THEN PROCEEDED WITH BIOPSY OF THE NODULE. DURING THE BIOPSY PHASE, THE EXTENDED WORKING CHANNEL WENT ¿OUT OF SENSING VOLUME.¿ THE PHYSICIAN DECIDED TO PROCEED WITH THE BIOPSY SINCE THE SURGEON NAVIGATED TO IT AND HAD VISUALIZATION UNDER FLUOROSCOPY. THE PHYSICIAN WAS ABLE TO COMPLETE THE SUPERDIMENSION PORTION OF THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25336846 ↗
• MalfunctionMay 29, 2026Failure to Advance; Connection Problem; Patient Data Problem

  IT WAS REPORTED THAT, DURING THE PROCEDURE, THE LOCATABLE GUIDE (LG) WAS NOT DETECTED OR RECOGNIZED AND AN EXTENDED WORKING CHANNEL (EWC) ISSUE IN WHICH THE CATHETER WAS NOT COUPLING AND COULD NOT REGISTER. THE CASE WAS COMPLETED BY OTHER MEANS.

  Patient problems: Insufficient Information

  MAUDE report 25332244 ↗
• MalfunctionApr 27, 2026Device Displays Incorrect Message; Patient Data Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER WOULD NOT REGISTER AND IT WAS SAYING OUT OF SENSING VOLUME. A NEW CATHETER WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000574 ↗
• MalfunctionApr 16, 2026Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A PROCEDURE, THE LOCATABLE GUIDE AND EXTENDED WORKING CHANNEL WAS OUTSIDE THE SENSOR SENSING VOLUME. THE PHYSICIAN WAS ABLE TO COMPLETE THE SUPERDIMENSION PORTION OF THE CASE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24900274 ↗
• MalfunctionMar 18, 2026Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A PROCEDURE, THE LOCATABLE GUIDE WAS INDICATED AS OUTSIDE OF THE SENSOR SENSING VOLUME. THE PHYSICIAN WAS ABLE TO COMPLETE THE SUPERDIMENSION PORTION OF THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24630624 ↗
• MalfunctionJan 5, 2026Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE LOCATABLE GUIDE INDICATED AS BEING OUTSIDE OF THE SENSOR SENSING VOLUME. A NEW KIT WAS OPENED AND THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE WITHOUT COMPLICATIONS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23968420 ↗
• MalfunctionDec 26, 2025Device Displays Incorrect Message; Patient Data Problem; Device Displays Incorrect Message; Patient Data Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, A GLITCH OCCURRED ON THE SYSTEM SCREEN, REPEATEDLY INDICATING THAT THE CATHETER WAS OUTSIDE THE SENSING VOLUME WHILE NAVIGATING TO THE LESION. ADDITIONALLY, THERE WAS GLITCHES DURING REGISTRATION, SHOWING IN AND OUT AND WHILE REGISTERING. A NEW KIT WAS OPENED AND THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23900739 ↗
• MalfunctionDec 8, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE NAVIGATION CATHETER WAS NOT DETECTED IN THE SENSING VOLUME WHILE ATTEMPTING TO COMPLETE AUTOMATIC REGISTRATION. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE BY USING ANOTHER NAVIGATION CATHETER KIT OFF THE SHELF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744471 ↗
• MalfunctionNov 18, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER WAS OUT OF SENSING VOLUME. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE BY USING ANOTHER SIMILAR CATHETER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23585864 ↗
• InjuryNov 12, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE PROCEDURE, A LARGE PIECE OF FILAMENT WAS PUSHED OUT OF THE EXTENDED WORKING CHANNEL. AFTER THE BIOPSY FORCEPS WAS PUSHED THROUGH THE CATHETER, A LONG WIRE TYPE ITEM WAS OBSERVED INSIDE THE PATIENT'S LUNG AND WAS SUBSEQUENTLY REMOVED. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23533683 ↗
• MalfunctionAug 20, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE WAS INDICATED AS BEING OUTSIDE OF THE SENSOR SENSING VOLUME. WHEN THE CATHETER WAS PLACED ON THE PATIENT'S CHEST, IT WAS WITHIN THE SENSING VOLUME, BUT AFTER A NEW REGISTRATION WAS PERFORMED, THE SAME ISSUE PERSISTED. THE PATIENT WAS DESCRIBED AS NORMAL SIZE. A NEW CATHETER WAS OPENED AND FUNCTIONED AS EXPECTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22855949 ↗
• MalfunctionAug 1, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PREOPERATIVELY, THE ARROWS ON THE EXTENDED WORKING CHANNEL OF THE DEVICE WERE LABELED INCORRECTLY FOR THE LOCATABLE GUIDE AND EXTENDED WORKING CHANNEL PLUG. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686046 ↗
• MalfunctionJul 21, 2025Failure to Advance; Device Displays Incorrect Message; Failure to Advance; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN A PHYSICIAN WENT TO PERFORM AUTOMATIC REGISTRATION, THE FIRST CATHETER WENT BETWEEN THE ERROR MESSAGES OF THE NAVIGATION CATHETER OUT OF SENSING VOLUME AND NOT COUPLED. THE SURGEON REPLACED THE CABLES AND THE PATIENT'S POSITION WAS CHECKED, BUT THE SAME ISSUE OCCURRED. ANOTHER CATHETER WAS THEN USED. LATER IN THE PROCEDURE, AFTER NAVIGATION AND BIOPSIES, THE ICON BEGAN JUMPING AND, EVENTUALLY, AN ERROR OF REPLACED LOCATABLE GUIDE (LG) APPEARED. ADDITIONALLY, THE CATHETER WAS BROKEN. THE CATHETER WAS REPLACED AGAIN, RESOLVING THE ISSUE. THE PHYSICIAN WAS ABLE TO COMPLETE THE SUPER DIMENSION PORTION OF THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22561503 ↗
• MalfunctionJun 16, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING THE PROCEDURE TO SAMPLE A SUSPICIOUS PERIPHERAL NODULE USING THE PROCEDURE KIT, AN ERROR MESSAGE "OUT OF SENSING VOLUME" APPEARED. THE FACILITY DID NOT HAVE ANOTHER 90 DEGREE CATHETER AVAILABLE AND HAD TO USE A 180 DEGREE CATHETER TO CONTINUE THE PROCEDURE, WHICH RESULTED IN A NON-DIAGNOSTIC OUTCOME. AN ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY (EBUS) LYMPH NODE TEST WAS ALSO CONDUCTED AND WAS DIAGNOSTIC. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214295 ↗
• MalfunctionJun 3, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SYSTEM READ THE DEVICE AS OUTSIDE THE SENSING VOLUME WHILE IN THE PATIENT. THE PHYSICIAN WAS ABLE TO COMPLETE THE SUPERDIMENSION PORTION OF THE CASE WITHOUT ANY COMPLICATIONS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131581 ↗
• MalfunctionMay 28, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE INDICATED AS OUTSIDE THE SENSOR SENSING VOLUME. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE BY REPLACING THE CATHETER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22101503 ↗
• MalfunctionMay 23, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PROCEDURE KIT WAS REPORTED AS NON-FUNCTIONING DUE TO BEING OUT OF SENSING VOLUME. THE CASE WAS CONTINUED AND FINALIZED WITH ANOTHER CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078687 ↗
• MalfunctionMay 23, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PROCEDURE KIT WAS REPORTED AS NON-FUNCTIONING DUE TO BEING OUT OF SENSING VOLUME. THE CASE WAS CONTINUED AND FINALIZED WITH ANOTHER CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078640 ↗
• MalfunctionMay 21, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE INDICATED IT WAS OUTSIDE OF THE SENSOR SENSING VOLUME. THE STAFF CONFIRMED THE PROPER LOCATION BOARD AND PATIENT SENSOR TRIPLET LOCATIONS. ANOTHER CATHETER WAS USED TO RESOLVE THE ISSUE. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22066692 ↗
• MalfunctionMay 19, 2025Patient Data Problem; Patient Data Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER WAS NOT REGISTERING OR APPEARING IN THE PROGRAM DESPITE BEING INSIDE THE PATIENT. THE PATIENT WAS ON THE TABLE WITH SENSORS CORRECTLY PLACED ON THE CHEST. THE PHYSICIAN ENCOUNTERED THIS ISSUE DURING THE "REGISTRATION" PORTION. TROUBLESHOOTING STEPS INCLUDED RESTARTING THE PROCEDURE PROGRAM, ENSURING PATCHES AND SENSORS WERE SECURED AND IN THE RIGHT PLACE, AND LIFT THE PATIENT UP/ DOWN TO SEE IF ANYTHING WOULD REGISTER. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE BY USING A NEW CATHETER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22048771 ↗
• MalfunctionMay 14, 2025Radiofrequency Interference (RFI); Failure to Advance; Device Displays Incorrect Message; Radiofrequency Interference (RFI); Failure to Advance; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A PROCEDURE, ERROR CODES WERE RECEIVED INDICATING "NAVIGATION CATHETER OUTSIDE OF SENSING VOLUME" AND "MAGNETIC INTERFERENCE." THE DISTANCE TO THE LESION UNEXPECTEDLY CHANGED FROM THREE CENTIMETERS (CM) TO OVER 300 CM, AND THE NAVIGATION CATHETER TURNED BLUE. TO RESOLVE THE ISSUE, A NEW KIT WAS USED. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22023060 ↗
• MalfunctionMay 12, 2025Device Displays Incorrect Message; Patient Data Problem; Device Displays Incorrect Message; Patient Data Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE TO BIOPSY A SUSPICIOUS LUNG LESION, THE PROCEDURE KIT WAS REPORTED AS NON-FUNCTIONING DUE TO BEING OUT OF SENSING VOLUME AND ISSUES WITH AUTOMATIC REGISTRATION. TROUBLESHOOTING STEPS INCLUDED REPLACING THE LOCATION BOARD CABLE AND A FIELD TECHNICIAN CHECKING THE FULL SYSTEM, WHICH FOUND NO DEFECTIVE SITUATION. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22006848 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K191394. One submission often covers many models, so check the product and lot details in each record.

• Z-2008-2023 · May 22, 2023 · Open, Classified
  Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS