Monarch Bronchscope 2.0/Monarch Platform (P2) MON-000006 (UDI B634MON0000060)Recalls & reported problems

Summary

The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI B634MON0000060), received between Mar 8, 2021 and Jul 27, 2026 — classified as 2 deaths, 92 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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, 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 109 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  During a robot-assisted bronchoscopy procedure, bleeding occurred and was controlled within minutes using cold saline and a balloon blocker. The patient remained stable, the procedure was aborted, and the patient was discharged home later that day ((b)(6)2026).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50008426 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  DURING A ROBOTICALLY ASSISTED BRONCHOSCOPY PROCEDURE TARGETING A RIGHT UPPER LOBE NODULE, AS THE PHYSICIAN ADVANCED THE RADIAL PROBE IT WAS NOTICED THAT THE PATIENT TURNED PURPLE. THE TEAM IMMEDIATELY ABORTED THE PROCEDURE AND REMOVED THE BRONCHOSCOPE AND RADIAL PROBE. THE PATIENT CODED BUT WAS REVIVED AND TRANSFERRED TO THE MEDICAL INTENSIVE CARE UNIT (MICU). PATIENT IS STABLE AND DISCHARGED FROM HOSPITAL ON (B)(6) 2026. NO BIOPSIES WERE TAKEN, AND THERE WERE NO REPORTED ISSUES WITH THE DEVICES. THE PHYSICIAN ATTRIBUTED THE EVENT TO ANESTHESIA AND THE PATIENT¿S UNDERLYING HEALTH ISSUE.

  Patient problems: Cardiac Arrest

  MAUDE report 25105317 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  DURING A MONARCH BRONCHOSCOPY PROCEDURE, BLEEDING OCCURRED FOLLOWING WITHDRAWAL OF THE SCOPE AND INSERTION OF A CRYOPROBE. BIOPSY WAS SUCCESSFULLY OBTAINED AND THE PROCEDURE WAS COMPLETED. NO DEVICE-RELATED ISSUES WERE IDENTIFIED. THE PATIENT WAS TRANSFERRED TO THE ICU FOR MONITORING AND DISCHARGED ON (B)(6) 2026.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25052767 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE TEAM STRUCK THE PATIENT'S AORTA WHILE PERFORMING A BIOPSY WITH AN OLYMPUS PREVIEW NEEDLE. COLD SALINE WAS INJECTED AND THE CASE WAS ABORTED. THE PATIENT WAS HOSPITALIZED AND DISCHARGED THE NEXT DAY, (B)(6) 2026. NO DEVICE-RELATED ISSUES WERE REPORTED.

  Patient problems: Aortic dissection

  MAUDE report 24867158 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  AFTER SUCCESSFUL MONARCH BRONCHOSCOPY, THE PATIENT DEVELOPED A PNEUMOTHORAX REQUIRING HOSPITALIZATION AND WAS DISCHARGED ON (B)(6) 2026. NO DEVICE-RELATED ISSUES WERE IDENTIFIED.

  Patient problems: Pneumothorax

  MAUDE report 24832093 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  AFTER FOLLOWING A SUCCESSFUL MONARCH BRONCHOSCOPY, THE PATIENT DEVELOPED A PNEUMOTHORAX AND WAS SUBSEQUENTLY HOSPITALIZED AND RELEASED ON (B)(6) 2026. NO DEVICE-RELATED ISSUES WERE REPORTED.

  Patient problems: Pneumothorax

  MAUDE report 24694277 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. PATIENT WAS HOSPITALIZED AND CHEST TUBE WAS PLACED. THE PNEUMOTHORAX RESOLVED AND THE PATIENT WAS RELEASED . NO DEVICE ISSUES WERE REPORTED.

  Patient problems: Pneumothorax

  MAUDE report 24608241 ↗
• InjuryFeb 27, 2026Failure to Read Input Signal

  IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED A SCOPE ISSUE AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24477192 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. PATIENT WAS HOSPITALIZED AND CHEST TUBE WAS PLACED. THE PNEUMOTHORAX RESOLVED AND THE PATIENT WAS RELEASED ON (B)(6) 2026. NO DEVICE ISSUES WERE REPORTED.

  Patient problems: Pneumothorax

  MAUDE report 24457348 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. PATIENT WAS HOSPITALIZED AND PIGTAIL CATHETER WAS PLACED. THE PNEUMOTHORAX RESOLVED AND THE PATIENT WAS RELEASED ON (B)(6) 2026. NO DEVICE ISSUES WERE REPORTED.

  Patient problems: Pneumothorax

  MAUDE report 24457041 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. PATIENT WAS HOSPITALIZED AND CHEST TUBE WAS PLACED. THE PNEUMOTHORAX RESOLVED AND THE PATIENT WAS RELEASED ON (B)(6) 2026. NO DEVICE ISSUES WERE REPORTED.

  Patient problems: Pneumothorax

  MAUDE report 24408265 ↗
• InjuryFeb 20, 2026Program or Algorithm Execution Problem

  IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE, THE PHYSICIAN ENCOUNTERED SYSTEM ISSUES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24406146 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX THAT REQUIRED TUBE THORACOSTOMY.

  Patient problems: Pneumothorax

  MAUDE report 24406116 ↗
• InjuryFeb 18, 2026Application Program Problem

  IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE, THE PHYSICIAN ENCOUNTERED NAVIGATION ISSUES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378743 ↗
• DeathFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  DURING BRONCHOSCOPY, THE PATIENT BECAME HYPOTENSIVE. THE CRITICAL CARE PULMONOLOGY TEAM WAS CALLED TO THE BEDSIDE. A CHEST TUBE WAS INSERTED AND AN IMMEDIATE GUSH OF AIR WAS OBSERVED. SHORTLY THEREAFTER THE PATIENT ARRESTED AND CPR WAS INITIATED. A LARGER-BORE CHEST TUBE WAS PLACED, RESULTING AGAIN IN A GUSH OF AIR. THE PATIENT WAS PRONOUNCED DEAD BY THE CRITICAL CARE TEAM. NECROTIC MATERIAL WAS EXPELLED DURING THE EVENT. A RAB (ROBOT-ASSISTED BRONCHOSCOPY) WITH 7-NEEDLE ASPIRATION WAS PERFORMED. THE DEATH WAS PRESUMED TO BE DUE TO A TENSION PNEUMOTHORAX. NO ISSUES WERE REPORTED WITH THE DEVICES USED DURING THE PROCEDURE.

  Patient problems: Low Blood Pressure/ Hypotension; Pneumothorax

  MAUDE report 24274522 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN OBSERVED BLEEDING. THE CASE WAS COMPLETED; THE BLEEDING OCCURRED IN ASSOCIATION WITH A CRYOBIOPSY, AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT WAS SUBSEQUENTLY DISCHARGED FROM THE HOSPITAL AND A DIAGNOSIS WAS ESTABLISHED. THE PHYSICIAN DID NOT ATTRIBUTE THIS EVENT TO THE MONARCH SYSTEM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24222619 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. PATIENT WAS HOSPITALIZED AND CHEST TUBE WAS PLACED. THE PNEUMOTHORAX RESOLVED AND THE PATIENT WAS RELEASED ON (B)(6) 2026. NO DEVICE ISSUES WERE REPORTED.

  Patient problems: Pneumothorax

  MAUDE report 24152176 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. PATIENT WAS HOSPITALIZED AND CHEST TUBE WAS PLACED. THE PATIENT WAS RELEASED ON (B)(6) 2025. NO DEVICE ISSUES WERE REPORTED.

  Patient problems: Pneumothorax

  MAUDE report 23811140 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED A SCOPE ISSUE AND DID NOT USE ANY ADDITIONAL SCOPES TO CONTINUE THE PROCEDURE. THE PHYSICIAN ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744926 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED A SCOPE ISSUE AND DID NOT HAVE ANY ADDITIONAL SCOPES TO CONTINUE THE PROCEDURE. THE PHYSICIAN ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23735618 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. PATIENT WAS HOSPITALIZED AND CHEST TUBE WAS PLACED. THE PNEUMOTHORAX RESOLVED AND THE PATIENT WAS RELEASED ON (B)(6) 2025. NO DEVICE ISSUES WERE REPORTED.

  Patient problems: Pneumothorax

  MAUDE report 23730291 ↗
• DeathNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A ROBOTICALLY ASSISTED BRONCHOSCOPY PROCEDURE, AS THE PHYSICIAN WAS TAKING ANTERIOR/POSTERIOR SCOUT SHOTS USING A 3D C-ARM, THE PATIENT BEGAN TO EXHIBIT IRREGULAR HEART RHYTHMS. THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE. THE PATIENT WENT INTO ATRIAL FIBRILLATION AND CODED. CHEST COMPRESSIONS WERE STARTED IMMEDIATELY. THE CODE CONTINUED FOR 30 - 35 MINUTES, AND THE PATIENT PASSED AWAY. NO BIOPSIES OR NEEDLE ASPIRATIONS WERE PERFORMED DURING THE PROCEDURE. NO ISSUES WERE REPORTED INVOLVING THE DEVICES USED DURING THE PROCEDURE.

  Patient problems: Atrial Fibrillation

  MAUDE report 23587366 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE IT WAS FOUND THAT THE PATIENT HAD DEVELOPED BRONCHIECTASIS WHICH HAD NOT APPEARED IN PRE-OPERATIVE SCANS. APPROXIMATELY ONE TO TWO DAYS AFTER THE PROCEDURE, THE PATIENT DEVELOPED SEPSIS AND WAS ADMITTED TO THE HOSPITAL FOR FOUR DAYS AND TREATED WITH ANTIBIOTICS. THE PATIENT¿S LUNG BIOPSIES WERE FOUND TO BE CANCEROUS, AND A SURGICAL LUNG RESECTION WAS PERFORMED. THE LUNG RESECTION ALSO REMOVED THE BRONCHIECTASIS.

  Patient problems: Sepsis

  MAUDE report 23488215 ↗
• InjuryOct 28, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED SYSTEM FAULT MESSAGES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23409328 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE, THE PHYSICIAN ENCOUNTERED NAVIGATION ISSUES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064049 ↗