Monarch Bronchscope 2.0/Monarch Platform (P2)Recalls & reported problems across all models
Auris Health, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Monarch Bronchscope 2.0/Monarch Platform (P2) model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 109
- Deaths reported
- 2
- Injuries reported
- 92
- Recalls
- 1
We found 2 models of Monarch Bronchscope 2.0/Monarch Platform (P2) by Auris Health, Inc. in the FDA's device registry (GUDID). Together they are named in 109 adverse event reports in the FDA's MAUDE database, 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).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Reports received per month, all models
Monarch Bronchscope 2.0/Monarch Platform (P2) recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 21, 2026Open, Classified
Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to patient-left position; and if right position was previously selected, this may lead to unanticipated robotic arm positioning toward patient-left, may result in contact with patient/endotracheal tube.
Z-1383-2026 · Root cause: Software design · Recall details · FDA record ↗
Most reported Monarch Bronchscope 2.0/Monarch Platform (P2) problems
Device problems
- Adverse Event Without Identified Device or Use Problem80
- Appropriate Device Problem Term/Code Not Available9
- Insufficient Device Problem Information6
- Computer Software Problem4
- Unintended Movement4
- Application Program Problem3
- Loose or Intermittent Connection2
- Mechanical Problem2
Patient problems
- Pneumothorax52
- No Clinical Signs, Symptoms or Conditions42
- Hemorrhage/Blood Loss/Bleeding9
- Cardiac Arrest4
- Decreased Respiratory Rate2
- Dyspnea2
- Hemoptysis2
- Aortic dissection1
Monarch Bronchscope 2.0/Monarch Platform (P2) models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Monarch Bronchscope 2.0/Monarch Platform (P2) MON-000006Bronchoscope (Flexible Or Rigid)2 deaths109 reports
- Monarch Bronchscope 2.0/Monarch Platform (P2) MON-000006Bronchoscope (Flexible Or Rigid)1 recall0 reports
Recent Monarch Bronchscope 2.0/Monarch Platform (P2) adverse event reports
The 15 most recent reports across all models, 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 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page