ILLUMISITE ILS-1800-KTRecalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 10884521723818), received between Feb 21, 2020 and Sep 16, 2026 — classified as 28 injuries, 65 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (59 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 93 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Connection Problem

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

  MAUDE report 50794472 ↗
• MalfunctionAug 31, 2026Device Displays Incorrect Message

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50533263 ↗
• 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 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 ↗
• MalfunctionApr 24, 2026Device 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 24990330 ↗
• MalfunctionApr 11, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE CATHETER NEVER MADE IT TO THE PULMONOLOGY DEPARTMENT, AS WHEN RECEIVED, THE OUTER AND INNER-SHIPPING BOX WAS DAMAGED SO SEVERELY THAT THE STERILITY BARRIER WAS BROKEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24849174 ↗
• MalfunctionMar 17, 2026Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A PROCEDURE, THE LOCATABLE GUIDE WAS OUTSIDE OF THE SENSOR SENSING VOLUME. THE PHYSICIAN WAS UNABLE TO COMPLETE THE SUPERDIMENSION PORTION OF THE CASE, 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 24620485 ↗
• MalfunctionJan 22, 2026Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING USE OF THE DEVICE IN A PROCEDURE, THE NAVIGATION CATHETER WAS NOT RECOGNIZED IN THE SENSING VOLUME DURING AUTOMATIC REGISTRATION. THE PHYSICIAN WAS ABLE TO COMPLETE THE SUPERDIMENSION PORTION OF THE CASE, AND NO COMPLICATIONS, INJURIES, OR MEDICAL/SURGICAL INTERVENTIONS WERE REQUIRED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24152723 ↗
• MalfunctionJan 12, 2026Failure to Advance; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PATIENT HAD THREE DIFFERENT NODULE LOCATIONS. THE PHYSICIAN FIRST ATTEMPTED TO NAVIGATE TO A RIGHT UPPER LOBE NODULE, DURING WHICH THE CATHETER REPEATEDLY INDICATED IT WAS GOING IN AND OUT OF SENSING VOLUME AND THE CATHETER'S TIP COLOR ALTERNATED BETWEEN PURPLE AND BLUE ON THE SCREEN WHEN MOVED. NO CHANGES TOOK PLACE TO THE CATHETER (LOCATABLE GUIDE EXTENDED WORKING CHANNEL) OUTSIDE OF THE PATIENT. LOCATION OF PATIENT SENSOR TRIPLETS AND LOCATION BOARD LOCATIONS WERE CONFIRMED BOTH DURING SETUP AND INTRA-PROCEDURALLY. THE CATHETER WAS REPLACED WITH ANOTHER, AND THE (CGS) CONTINUES GUIDANCE SYSTEM WAS RESTARTED ON THE BACK OF THE TOWER; HOWEVER, THE SAME ISSUE OCCURRED. A THIRD CATHETER WAS RETRIEVED, AND AFTER INITIAL REGISTRATION, THE PHYSICIAN AGAIN ATTEMPTED TO REACH THE SAME NODULE, AND THE DEVICE STILL EXPERIENCED ISSUES, BUT WAS USED TO COMPLETE THE CASE. THE PHYSICIAN THEN NAVIGATED TO TWO LOWER LOBE NODULES, BUT ONLY ONE WAS BIOPSIED. THE SURGICAL TIME WAS EXTENDED FOR ABOUT 35 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24041910 ↗
• MalfunctionJan 12, 2026Failure to Advance; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PATIENT HAD THREE DIFFERENT NODULE LOCATIONS. THE PHYSICIAN FIRST ATTEMPTED TO NAVIGATE TO A RIGHT UPPER LOBE NODULE, DURING WHICH THE CATHETER REPEATEDLY INDICATED IT WAS GOING IN AND OUT OF SENSING VOLUME AND THE CATHETER'S TIP COLOR ALTERNATED BETWEEN PURPLE AND BLUE ON THE SCREEN WHEN MOVED. NO CHANGES TOOK PLACE TO THE CATHETER (LOCATABLE GUIDE EXTENDED WORKING CHANNEL) OUTSIDE OF THE PATIENT. LOCATION OF PATIENT SENSOR TRIPLETS AND LOCATION BOARD LOCATIONS WERE CONFIRMED BOTH DURING SETUP AND INTRA-PROCEDURALLY. THE CATHETER WAS REPLACED WITH ANOTHER, AND THE (CGS) CONTINUES GUIDANCE SYSTEM WAS RESTARTED ON THE BACK OF THE TOWER; HOWEVER, THE SAME ISSUE OCCURRED. A THIRD CATHETER WAS RETRIEVED, AND AFTER INITIAL REGISTRATION, THE PHYSICIAN AGAIN ATTEMPTED TO REACH THE SAME NODULE, AND THE DEVICE STILL EXPERIENCED ISSUES, BUT WAS USED TO COMPLETE THE CASE. THE PHYSICIAN THEN NAVIGATED TO TWO LOWER LOBE NODULES, BUT ONLY ONE WAS BIOPSIED. THE SURGICAL TIME WAS EXTENDED FOR ABOUT 35 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24041449 ↗
• MalfunctionJan 12, 2026Failure to Advance; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PATIENT HAD THREE DIFFERENT NODULE LOCATIONS. THE PHYSICIAN FIRST ATTEMPTED TO NAVIGATE TO A RIGHT UPPER LOBE NODULE, DURING WHICH THE CATHETER REPEATEDLY INDICATED IT WAS GOING IN AND OUT OF SENSING VOLUME AND THE CATHETER'S TIP COLOR ALTERNATED BETWEEN PURPLE AND BLUE ON THE SCREEN WHEN MOVED. NO CHANGES TOOK PLACE TO THE CATHETER (LOCATABLE GUIDE & EXTENDED WORKING CHANNEL) OUTSIDE OF THE PATIENT. LOCATION OF PATIENT SENSOR TRIPLETS AND LOCATION BOARD LOCATIONS WERE CONFIRMED BOTH DURING SETUP AND INTRA-PROCEDURALLY. THE CATHETER WAS REPLACED WITH ANOTHER, AND THE (CGS) CONTINUES GUIDANCE SYSTEM WAS RESTARTED ON THE BACK OF THE TOWER; HOWEVER, THE SAME ISSUE OCCURRED. A THIRD CATHETER WAS RETRIEVED, AND AFTER INITIAL REGISTRATION, THE PHYSICIAN AGAIN ATTEMPTED TO REACH THE SAME NODULE, AND THE DEVICE STILL EXPERIENCED ISSUES, BUT WAS USED TO COMPLETE THE CASE. THE PHYSICIAN THEN NAVIGATED TO TWO LOWER LOBE NODULES, BUT ONLY ONE WAS BIOPSIED. THE SURGICAL TIME WAS EXTENDED FOR ABOUT 35 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24041102 ↗
• MalfunctionDec 19, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING THE PROCEDURE, A LOCATABLE GUIDE ISSUE OCCURRED IN WHICH THE DEVICE WAS INDICATED AS OUTSIDE OF THE SENSOR SENSING VOLUME. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE BY OPENING A NEW KIT WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23857458 ↗
• InjuryNov 4, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE PROCEDURE, BIOPSY FORCEPS WERE INSERTED INTO THE EXTENDED WORKING CHANNEL AND, UPON REMOVAL, ABRADED PLASTIC STRIPS FROM THE INNER EXTENDED WORKING CHANNEL LAYER WERE FOUND BALLED IN THE FORCEPS JAW ALONG WITH TISSUE. THE EXTENDED WORKING CHANNEL WAS THEN REMOVED, AND THE FORCEPS WERE REINSERTED, BUT NO TISSUE WAS GAINED. THE PROCEDURE WAS COMPLETED WITHOUT NAVIGATION. THE ABRADED PLASTIC STRIPS WERE REMOVED USING FORCEPS AND SUCTION WITH IRRIGATION.

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

  MAUDE report 23467275 ↗
• InjuryOct 16, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE PROCEDURE FOR A SUSPICIOUS LUNG NODULE, THE INNER LAYER OF THE EXTENDED WORKING CHANNEL WAS ABRADED WHEN THE BIOPSY FORCEPS WERE INSERTED, RESULTING IN DEVICE FRAGMENTS BECOMING LOOSE IN THE PATIENT. THE INTERVENTION TIME WAS PROLONGED BUT NOT FOR MORE THAN 30 MINUTES AS THE FOREIGN BODIES HAD TO BE REMOVED FROM THE PATIENT PIECE BY PIECE. THE BIOPSY WAS ULTIMATELY PERFORMED WITHOUT THE USE OF THE EXTENDED WORKING CHANNEL AND NAVIGATION AT THE END OF THE PROCEDURE. ALL DEVICE FRAGMENTS WERE REMOVED FROM THE PATIENT. 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 23318684 ↗
• MalfunctionJul 9, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A PROCEDURE THE USER REPEATEDLY RECEIVED AN "OUT OF SENSING VOLUME" ERROR POP UP, WHICH INHIBITED WORKFLOW. TROUBLESHOOTING WAS PROVIDED OVER THE PHONE, BUT THE ISSUE WAS NOT RESOLVED. 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 22457665 ↗
• MalfunctionJun 23, 2025Device Displays Incorrect Message; Application Program Problem; Device Displays Incorrect Message; Application Program Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE ATTEMPTING TO ACCESS A LUNG NODULE IN THE RIGHT UPPER LOBE POSTERIOR SEGMENT, THERE WAS A LOSS OF CONTINUOUS GUIDANCE WHEN CLOSE TO THE TARGET. THERE WAS AN ERROR CODE OF NAVIGATION CATHETER OUTSIDE OF SENSING VOLUME. TO RESOLVE THE ISSUE, A 90-DEGREE CATHETER WAS THEN USED. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22308321 ↗
• MalfunctionMay 16, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE NAVIGATION BRONCHOSCOPY PROCEDURE WENT WELL AND DIFFERENT BIOPSY TOOLS WERE USED IN DIFFERENT POSITIONS AND ANGLES TO THE TARGET: FORCEPS TWO TYPES, CRYOPROBE 1.1MM. AT THE END AFTER A FORCEPS BIOPSY, THE ERROR "OUT OF SENSING VOLUME" SHOWED UP AND NOT FURTHER NAVIGATION WAS POSSIBLE. HOWEVER, THE PHYSICIAN DECIDED TO CONCLUDE THE PROCEDURE AS THE NUMBER OF TISSUE SAMPLES OBTAINED WAS DEEMED SUFFICIENT. 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 22040907 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BEFORE STARTING THE PROCEDURE, THE SURGEON COULD NOT COUPLE THE CATHETER. A NEW DEVICE OF THE SAME TYPE WAS THEN USED DURING THE PROCEDURE. THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. HOWEVER, DURING THE BIOPSY, THE PATIENT HAD PNEUMOTHORAX. THE PATIENT RECEIVED A CHEST TUBE AS PART OF THE INTERVENTION.

  Patient problems: Pneumothorax

  MAUDE report 22010987 ↗
• MalfunctionMay 8, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A PROCEDURE, THERE WAS A LOCATABLE GUIDE ISSUE WHERE THE DEVICE WAS INDICATED AS OUTSIDE OF THE SENSOR SENSING VOLUME. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. THE CATHETER WAS SWITCHED WITH 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 21990577 ↗
• InjuryApr 21, 2025Failure to Advance; Device Displays Incorrect Message; Application Program Problem; Patient Data Problem; Failure to Advance; Device Displays Incorrect Message; Application Program Problem; Patient Data Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE REGISTRATION COULD NOT BE COMPLETED DUE TO NAVIGATION CATHETER OUT OF SENSING VOLUME AND NOT COUPLED ERROR. A NEW DEVICE WAS USED, BUT THE SAME ISSUE OCCURRED. 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 21874516 ↗
• InjuryApr 1, 2025Failure to Advance; Device Displays Incorrect Message; Application Program Problem; Patient Data Problem; Failure to Advance; Device Displays Incorrect Message; Application Program Problem; Patient Data Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE REGISTRATION COULD NOT BE COMPLETED DUE TO NAVIGATION CATHETER OUT OF SENSING VOLUME AND NOT COUPLED ERROR. A NEW DEVICE WAS USED, BUT THE SAME ISSUE OCCURRED. THE PHYSICIAN WAS UNABLE TO COMPLETE THE SUPERDIMENSION PORTION OF THE CASE. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND WAS WOKEN UP WITHOUT COMPLETING THE CASE. IT WAS NOTED THAT THE PROCEDURE WAS RESCHEDULED FOR ANOTHER WEEK.

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

  MAUDE report 21746708 ↗
• InjuryMar 26, 2025Application Program Problem; Adverse Event Without Identified Device or Use Problem; Patient Data Problem; Application Program Problem; Adverse Event Without Identified Device or Use Problem; Patient Data Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, A MAJOR AIRWAY BLEED OF UNSPECIFIED AMOUNT OCCURRED DURING FINAL AUTOMATIC REGISTRATION. A STENT WAS USED TO RESOLVE THE ISSUE. THE PHYSICIAN WAS UNABLE TO COMPLETE THE SUPERDIMENSION PORTION OF THE CASE, AND THE ENTIRE NAVIGATION HAD TO BE ABORTED TO STABILIZE THE PATIENT. THE PHYSICIAN WAS USING A NAVIGATION CATHETER WHEN THE BLEED BEGAN. THE PROCEDURE WAS EXTENDED FOR MORE THAN 30 MINUTES AND WAS COMPLETED BY OTHER MEANS. THE PATIENT HAD TO STAY OVERNIGHT AND WAS ABLE TO LEAVE THE NEXT DAY.

  Patient problems: Bronchial Hemorrhage

  MAUDE report 21704039 ↗
• MalfunctionMar 5, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING AN ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB) PROCEDURE, AN ERROR MESSAGE APPEARED THAT THE EXTENDED WORKING CHANNEL WAS OUTSIDE OF THE SENSING VOLUME ON ALL THREE CATHETERS. A FOURTH CATHETER WAS USED TO RESOLVE THE ISSUE. THE PHYSICIAN WAS ABLE TO COMPLETE THE SUPERDIMENSION PORTION OF THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21531784 ↗
• MalfunctionMar 5, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING A ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB) PROCEDURE, AN ERROR MESSAGE APPEARED THAT THE EXTENDED WORKING CHANNEL WAS OUTSIDE OF THE SENSING VOLUME ON ALL THREE CATHETERS. A FOURTH CATHETER WAS USED TO RESOLVE THE ISSUE. THE PHYSICIAN WAS ABLE TO COMPLETE THE SUPERDIMENSION PORTION OF THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21531721 ↗

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