ILLUMISITE ILS-0450-KTRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521723832), received between Oct 29, 2020 and May 27, 2026 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (5 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 16, 2026.

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.

• MalfunctionMay 27, 2026Use of Device Problem; Connection Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER WAS NOT RECOGNIZED AFTER THE FIRST BIOPSY PASS AND AN OUT-OF-SENSING-VOLUME ERROR WAS OBSERVED. AN EXTENDED WORKING CHANNEL (EWC) ISSUE WAS REPORTED, INCLUDING INABILITY TO DEFLECT THE TIP. TROUBLESHOOTING STEPS WERE PERFORMED AND NO MAGNETIC INTERFERENCE WAS NOTED, THE PATIENT SENSOR TRIPLET (PST) DID NOT MOVE. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE BY OPENING A NEW CATHETER KIT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25302837 ↗
• MalfunctionFeb 9, 2026Use of Device Problem; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A PROCEDURE, THE EXTENDED WORKING CHANNEL ISSUE HAD AN INABILITY TO DEFLECT THE TIP WITH THE ORIGINAL LOCATABLE GUIDE, AND IT WAS NOT SENSING AS WELL. THE PHYSICIAN AND STAFF ATTEMPTED TROUBLESHOOTING, BUT THE ISSUE WAS NOT RESOLVED. A NEW CATHETER KIT WAS OPENED, REPLACING THE EXTENDED WORKING CHANNEL (EWC) TO FINISH THE PROCEDURE. 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 24297640 ↗
• MalfunctionSep 25, 2024Device Displays Incorrect Message; Application Program Problem; Device Displays Incorrect Message; Application Program Problem

  ACCORDING TO THE REPORTER, DURING AN ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB), THE ERROR MESSAGE IS SHOWING A "CATHETER OUT OF SENSING VOLUME" ERROR. THE DOCTOR TRIED TO RECOUPLE THE LOCATABLE GUIDE AND NAVIGATE BACK AND FORTH A FEW TIMES. EVENTUALLY THE ENTIRE KIT HAD TO BE REPLACED AND START THE WHOLE PROCEDURE OVER FROM REGISTRATION. THE PHYSICIAN WAS ABLE TO COMPLETE THE SUPERDIMENSION PORTION OF THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300585 ↗
• MalfunctionJul 25, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, IN THE REGISTRATION PROCESS, THE DEVICE WAS INDICATED AS OUTSIDE OF THE SENSOR SENSING VOLUME. THE CABLES WERE CHANGED, BUT IT DID NOT CHANGE ANYTHING. TO RESOLVE THE ISSUE, A NEW NAVIGATION KIT WAS USED. 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 19826482 ↗
• MalfunctionApr 11, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AN ERROR CODE KEPT POPPING OUT THAT THE LOCATABLE GUIDE (LG) WAS OUT OF SENSING VOLUME. THE USER TRIED TO TROUBLESHOOT. THE ERROR WENT AWAY WHEN A NEW DEVICE WAS USED. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHSCOPY (ENB) PORTION OF THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19088783 ↗
• MalfunctionJan 22, 2024Material Fragmentation; Connection Problem; Material Fragmentation; Connection Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE LOCATABLE GUIDE (LG) WAS NOT DETECTED OR RECOGNIZED. THE CENTER PROBE WAS LOSING CONNECTION. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. THE CASE WAS COMPLETED BY OPENING A NEW CATHETER KIT. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THAT THE STRING LIKE FIBER WAS DETERMINED TO BE FROM SCRAPING THE INNER LINER. THE CAUSE IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552443 ↗
• MalfunctionNov 6, 2023Failure to Advance; Device Displays Incorrect Message; Failure to Advance; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER REGISTERING THE PATIENT, THE USER WAS GETTING AN ERROR MESSAGE THAT THE LOCATABLE GUIDE (LG) WAS NOT COUPLED TO THE EXTENDED WORKING CHANNEL (EWC). TRIED PASSING A TOOL THROUGH IT AND STILL GOT THE ERROR. EVEN WITH NOTHING IN THE CATHETER, THERE WAS AN ERROR STATING THAT THERE WAS AN OUT OF SENSING VOLUME. THE PATIENT WAS POSITIONED ON THE BOARD CORRECTLY. THE CATHETER WAS REPLACED WITH ANOTHER KIT OF THE SAME TYPE, AND THE ISSUE NO LONGER OCCURRED. 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 18075316 ↗
• MalfunctionOct 26, 2023Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, A PIECE OF PLASTIC WAS NOTICED ON THE FORCEPS AFTER THE BIOPSY. THE ANGLE WAS ADJUSTED, AND NO FURTHER PLASTIC WAS FOUND IN THE FOLLOWING BIOPSIES.

  Patient problems: Insufficient Information

  MAUDE report 18016395 ↗
• MalfunctionOct 25, 2023Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, A PIECE OF PLASTIC WAS NOTICED ON THE FORCEPS AFTER THE BIOPSY.

  Patient problems: Insufficient Information

  MAUDE report 18007296 ↗
• MalfunctionOct 9, 2023Connection Problem; Patient Data Problem; Connection Problem; Patient Data Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE LOCATABLE GUIDE (LG) WAS NOT DETECTED OR RECOGNIZED. THE ACCOUNT STATED THAT ON THE AUTOMATIC REGISTRATION PROCESS, THE CATHETER WAS NOT REGISTERING ANY OF THE GREEN CHECKMARKS AS THE PHYSICIAN WENT THROUGH HIS NORMAL ROUTINE. THE PHYSICIAN TRIED UNPLUGGING ALL CABLES AND EVEN TRIED RE-REGISTERING MULTIPLE TIMES. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE BY SWAPPING OUT THE 45 CATHETER THAT WAS NOT WORKING FOR A 90 DEGREE CATHETER AND HAD NO FURTHER ISSUES WITH THE REST OF THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17895321 ↗
• InjurySep 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, THIS STUDY AIMED TO ASSESS A VANDERBILT UNIVERSITY OF PATIENTS UNDERGOING ELECTROMAGNETIC NAVIGATION BR ONCHOSCOPY TO AID IN THE DIAGNOSIS OF PERIPHERAL LUNG LESIONS. 100 LUNG LESIONS WERE SAMPLED IN 82 PATIENTS. A TH-190 THERAPEUTIC BRONCHOSCOPE (OLYMPUS AMERICA© [CENTER VALLEY, PA, USA]) WAS USED FOR EVERY PROCEDURE. AFTER THE AIRWAY EXAMINATION WAS COMPLETED, THE PRESELECTED ILLUMISITE EXTENDED WORKING CHANNEL (EWC) WITH A LOCATABLE GUIDE (LG) WAS INTRODUCED INTO THE WORKING CHANNEL. REGISTRATION WAS COMPLETED, AND PERIPHERAL NAVIGATION WAS COMMENCED. PNEUMOTHORAX: THREE (3) PNEUMOTHORACES WERE IDENTIFIED IN THE IMMEDIATE POSTPROCEDURE PHASE AND REQUIRED MANAGEMENT WITH A CHEST TUBE. BLEEDING: BLEEDING REQUIRING INTERVENTION IN 2 PATIENTS (DEFINED AS GRADE 2¿4 OF THE NASHVILLE WORKING GROUP SCALE) WAS NOTED. THERE WERE NO PROCEDURE-RELATED HOSPITAL ADMISSIONS. OXYGEN SUPPORT NEEDED: FIVE PERCENT OF PATIENTS REQUIRED TEMPORARY SUPPLEMENTAL OXYGEN SUPPORT. THIS WAS DEFINED AS A DE NOVO NEED FOR SUPPLEMENTAL OXYGEN OR AN INCREASE IN THEIR PREVIOUSLY PRESCRIBED AMBULATORY SUPPLY. EWC-LG UNCOUPLING: ¿ALTHOUGH UNCOMMON, WE EXPERIENCED A HANDFUL OF ELECTRON

  Patient problems: Pneumothorax

  MAUDE report 12518075 ↗
• InjuryMar 18, 2021Failure to Advance; Application Program Problem; Adverse Event Without Identified Device or Use Problem; Patient Data Problem; Failure to Advance; Application Program Problem; Adverse Event Without Identified Device or Use Problem; Patient Data Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE LOCATABLE GUIDE (LG) STATED IT WAS DECOUPLED WHEN IT WAS STILL CONNECTED WITH LG. EVERYTHING WAS CONNECTED CORRECTLY AND REGISTERED TWICE AND STILL RECEIVED SAME MESSAGE. LOCAL REGISTRATION WOULD NOT LAUNCH EVEN WHEN THE PHYSICIAN NAVIGATED WITHIN 1CM OF THE NODULE. THE SYSTEM WAS SHOWING IT WAS DECOUPLED AND THE LAUNCH BUTTON IN THE TOP RIGHT CORNER WAS JUST GRAY AND NOT ABLE TO LAUNCH LOCAL REGISTRATION. THE PROCEDURE WAS NOT COMPLETED AND WAS NOT COMPLETED BY OTHER MEANS. THE PATIENT EXPERIENCE PNUEMOTHORAX. THE HOSPITALIZATION WAS EXTENDED FOR A MINIMUM OF 1 DAY UNTIL PNEUMOTHORAX IS RESOLVED.

  Patient problems: Pneumothorax

  MAUDE report 11518672 ↗
• InjuryMar 4, 2021Display or Visual Feedback Problem; Application Program Problem; Patient Data Problem; Display or Visual Feedback Problem; Application Program Problem; Patient Data Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THERE WAS A FLUORONAV ISSUE, IT WAS JUST PRIOR TO THE SWEEP THE PHYSICIAN WAS 1CM FROM THE TARGET, THEN DURING THE SWEEP THE SCREEN WOULD SAY THE LG MOVED TOO MUCH AND WOULD SUDDENLY SAY THE LG WAS 4CM+ FROM THE TARGET. THEN, A SECOND LATER IT WOULD SHOW THE LG BACK AT 1CM FROM THE TARGET. FLUORO CONFIRMED THAT THE LG HAD NOT MOVED. THE PHYSICIAN TRIED TO PERFORM THE SWEEP A TOTAL OF 3 TIMES WITH THIS LG AND THE SAME ERROR OCCURRED EVERY TIME AND FLUORO CONFIRMED THE LG HAD NOT MOVED. THE PHYSICIAN TRIED ANOTHER KIT, WHILE THE LG WAS IN AFTER FLURONAV UPDATED OUR LOCATION, THE SCREEN WOULD FLICKER BACK AND FORTH BETWEEN 4 AND 6CM WITHOUT ANY MOVEMENT. ALSO, WHEN THE EWC WAS IN WITH RADIAL PROBE THE CATHETER WAS 2CM FROM REACHING THE TARGET, BUT IT WAS EXTENDED TO THE MAX AND COULD NOT GO FURTHER. THE PHYSICIAN WAS UNABLE TO COMPLETE THE ENB PORTION OF THE CASE AND WAS UNABLE TO COMPLETE THE CASE BY OTHER MEANS.

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

  MAUDE report 11413317 ↗
• MalfunctionOct 29, 2020Material Fragmentation; Unstable; Material Fragmentation; Unstable

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE WIRING STARTED TO COME LOSE AND FALL OFF EWC. DURING FORCEP BIOPSIES IT BECAME APPARENT THAT WIRING WAS UNRAVELING FROM THE DISTAL TIP OF THE EWC AND COMING OFF ON THE FORCEPS. THE SURGEON REMOVED EWC AND COULD SEE WIRING UNRAVELING FROM DISTAL TIP. THE PHYSICIAN WAS ABLE TO COMPLETE THE ENB PORTION OF THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10756457 ↗

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