ILLUMISITERecalls & reported problems across all models

We found 7 models of ILLUMISITE by Covidien LP in the FDA's device registry (GUDID). Together they are named in 318 adverse event reports in the FDA's MAUDE database, received between Jan 30, 2020 and Sep 23, 2026 — classified as 2 deaths, 139 injuries, 177 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (167 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ILLUMISITE problems

ILLUMISITE models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ILLUMISITE ILS-1000-CS

  System, x-ray, tomography, computed
  1 death103 reports
• ILLUMISITE ILS-1800-KT

  System, x-ray, tomography, computed
  93 reports
• ILLUMISITE ILS-0900-KT

  System, x-ray, tomography, computed
  89 reports
• ILLUMISITE ILS-0450-KT

  System, x-ray, tomography, computed
  14 reports
• ILLUMISITE ILS-1000-CS

  System, x-ray, tomography, computed
  9 reports
• ILLUMISITE ILS-1000-CS

  System, x-ray, tomography, computed
  1 death8 reports
• ILLUMISITE ILS-1000-CS

  System, x-ray, tomography, computed
  2 reports

Recent ILLUMISITE adverse event reports

The 15 most recent reports across all models, 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 50794472 ↗
• MalfunctionSep 16, 2026Connection Problem

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

  MAUDE report 50794376 ↗
• MalfunctionSep 15, 2026Patient Data Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50782311 ↗
• 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 ↗
• MalfunctionAug 31, 2026Device Displays Incorrect Message

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50533263 ↗
• MalfunctionAug 14, 2026Patient Data Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50261793 ↗
• 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 ↗
• InjuryMay 28, 2026Application Network Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PHYSICIAN EXTENDED BEYOND THE PLEURAL BOUNDARY, AND AS A RESULT, THE PATIENT EXPERIENCED A PNEUMOTHORAX. AFTER THE PNEUMOTHORAX, THERE WAS SYSTEM INACCURACY, AS THE LOCATION AND SHAPE OF THE LUNG CHANGED. A CHEST TUBE WAS USED TO RESOLVE THE ISSUE. IT WAS REPORTED THAT THE SUPERDIMENSION PORTION OF THE CASE WAS COMPLETED, THE PATIENT DID WELL, AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: Pneumothorax

  MAUDE report 25325143 ↗
• 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 ↗
• MalfunctionApr 27, 2026Failure to Advance; Device Displays Incorrect Message; Connection Problem; Patient Data Problem

  IT WAS REPORTED THAT, DURING THE PROCEDURE, THE LOCATABLE GUIDE WAS NOT DETECTED OR RECOGNIZED AND THERE WAS A NAVIGATION CATHETER NOT COUPLED ERROR MESSAGE AND COULD NOT REGISTER. THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE WAS NOT COMPLETED BUT THE CASE WAS COMPLETED BY OTHER MEANS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000736 ↗
• 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 24, 2026Display or Visual Feedback Problem; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A PROCEDURE, THE EXTENDED WORKING CHANNEL WAS OBSERVED AS OUTSIDE OF THE SENSING VOLUME AND WAS JUMPING ON THE SCREEN. THIS ISSUE OCCURRED ON THREE DEVICES. 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 24990526 ↗
• MalfunctionApr 24, 2026Display or Visual Feedback Problem; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A PROCEDURE, THE EXTENDED WORKING CHANNEL WAS OBSERVED AS OUTSIDE OF THE SENSING VOLUME AND WAS JUMPING ON THE SCREEN. THIS ISSUE OCCURRED ON THREE DEVICES. 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 24990374 ↗

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