BFlex™ BFlex™ 2 Regular 5.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00879123008565), received between Jun 13, 2023 and Aug 14, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Degraded; Material Disintegration; Flaked

  Patient problems: Aspiration/Inhalation; Foreign Body In Patient

  MAUDE report 50260403 ↗
• InjuryJul 28, 2026Degraded; Material Disintegration; Flaked

  A customer reported while using BFlex 2 Regular 5.0 and BFlex 2 Large 5.8 Single-Use Bronchoscopes during a patient procedure in the Intensive Care Unit (ICU), part of their plastic casing started disintegrating and ended up in the patient's airway. An additional procedure via bedside bronchoalveolar lavage (BAL) was required to recover the remainder of the particles that were left in the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50062269 ↗
• MalfunctionApr 21, 2026Material Separation; Material Split, Cut or Torn

  A CUSTOMER REPORTED THE TIP OF A BFLEX 2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE WAS DAMAGED WHEN THEY ATTEMPTED TO INSERT THE BRONCHOSCOPE INTO THE PATIENT. NO DELAY IN PROCEDURE, USE OF A BACKUP DEVICE, OR HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24943977 ↗
• MalfunctionOct 28, 2025Degraded; Flaked; Degraded; Flaked

  A CUSTOMER REPORTED THAT A BFLEX 2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE WAS DISCOVERED TO CONTAIN DEBRIS WITHIN THE STERILE PACKAGING. UPON FURTHER INSPECTION, THE DEBRIS WAS FOUND TO ORIGINATE FROM A COMPROMISED TIP OF THE BRONCHOSCOPE AND WAS LOCATED FURTHER INSIDE THE TUBE WHERE IT WOULD HAVE BEEN INSERTED. THE BRONCHOSCOPE WAS INSPECTED PRIOR TO USE, AND THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23405798 ↗
• MalfunctionAug 5, 2025Display or Visual Feedback Problem; Poor Quality Image; Display or Visual Feedback Problem; Poor Quality Image

  A CUSTOMER REPORTED THAT DURING A BRONCHOSCOPY PROCEDURE IN THE ICU USING A BFLEX 2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE WITH A GLIDESCOPE CORE 15-INCH FHD MONITOR, THE BRONCHOSCOPE IMAGE WENT BLACK AND DISPLAYED COLORED LINES. THE BRONCHOSCOPE WAS REMOVED FROM THE AIRWAY AND CLEANED, BUT THE ISSUE PERSISTED. THE DEVICE WAS TAKEN OUT OF SERVICE, AND THE PROCEDURE WAS COMPLETED USING A NEW BRONCHOSCOPE FROM A DIFFERENT LOT. NO HARM TO THE PATIENT WAS REPORTED. THE FACILITY ATTEMPTED TO RECREATE THE ISSUE USING THE SAME AND DIFFERENT COMPONENTS BUT WAS UNABLE TO REPLICATE THE FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720784 ↗
• MalfunctionAug 5, 2025Display or Visual Feedback Problem; Poor Quality Image; Display or Visual Feedback Problem; Poor Quality Image

  A CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, A BFLEX 2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE WAS PLUGGED IN ALONGSIDE A LARYNGOSCOPE BLADE FOR APPROXIMATELY 10 MINUTES DURING CASE SETUP. WHEN THE CASE BEGAN, THE CRNA SELECTED THE BFLEX 2 REGULAR 5.0 SCOPE TO INTUBATE A PATIENT WITH A KNOWN DIFFICULT AIRWAY. THE SCOPE WAS CONFIRMED TO BE POWERED ON WITH AN IMAGE VISIBLE PRIOR TO USE. UPON INSERTION INTO THE PATIENT'S NOSE, THE IMAGE BRIEFLY TURNED RED/GREEN AND THEN IMMEDIATELY WENT BLACK. THE CRNA UNPLUGGED THE SCOPE AND COMPLETED THE INTUBATION USING A MAC3 BLADE, WHICH REMAINED CONNECTED THROUGHOUT. THE BLADE VIDEO WAS NOT IN USE AT THE TIME OF THE ISSUE (NOT A DUAL-VIEW SETUP). A VERATHON CLINICAL SPECIALIST WAS PRESENT IN THE ROOM, RETAINED THE AFFECTED SCOPE, AND ATTEMPTED TO RECREATE THE REPORTED ISSUE MULTIPLE TIMES WITHOUT SUCCESS. AN ADDITIONAL ATTEMPT TO REPLICATE THE BEHAVIOR WAS CONDUCTED THE FOLLOWING MORNING, AGAIN WITH NO RECURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720783 ↗
• MalfunctionMay 13, 2025Off-Label Use; Failure to Advance; Device-Device Incompatibility; Off-Label Use; Failure to Advance; Device-Device Incompatibility

  A CUSTOMER REPORTED DURING A PATIENT PROCEDURE, A BFLEX 2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE BECAME LODGED IN A 39 FR DOUBLE-LUMEN TUBE (DLT). THE PATIENT ENDED UP HAVING TO BE REINTUBATED AS A RESULT AFTER REMOVING THE DLT WITH THE BRONCHOSCOPE STILL STUCK IN THE TUBE. NO DELAY IN THE PROCEDURE OR HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011695 ↗
• MalfunctionApr 29, 2025Erratic or Intermittent Display; Display or Visual Feedback Problem; Erratic or Intermittent Display; Display or Visual Feedback Problem

  A CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A BFLEX 2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE, THE IMAGE ON THE CONNECTED GLIDESCOPE CORE MONITOR WAS FLICKERING IN AND OUT. THEY TRIED USING THE BRONCHOSCOPE ON A DIFFERENT GLIDESCOPE CORE MONITOR; HOWEVER, THE ISSUE PERSISTED. NO DELAY IN THE PROCEDURE, USE OF A BACKUP DEVICE, OR HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928739 ↗
• MalfunctionMar 6, 2025Display or Visual Feedback Problem; Poor Quality Image; Display or Visual Feedback Problem; Poor Quality Image

  A CUSTOMER REPORTED WHILE PERFORMING A BRONCHOALVEOLAR LAVAGE (BAL) BRONCHOSCOPY WITH A BFLEX 2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE, THE PICTURE ON THE SCREEN FRIZZED OUT WHEN INJECTING THE BOLUS. THEY REPORTED THE PICTURE SNOWED OUT AND DISPLAYED TRACKING LINES, OBSCURING ABOUT 90% OF THE IMAGE. WHILE IT WAS REPORTED THAT THIS EVENT HAPPENED DURING INSTILLATION OF SALINE VIA 60CC SYRINGE, IT PERSISTED AFTER THE SYRINGE WAS EMPTIED AND WHEN SUCTIONING. THE BRONCHOSCOPE WAS REMOVED AND SWITCHED TO A NEW ONE. AFTER COMPLETING THE BRONCHOSCOPY, THE CUSTOMER RECONNECTED THE AFFECTED BRONCHOSCOPE AND REPORTED IT FUNCTIONED NORMALLY. NO DELAY IN THE PROCEDURE OR HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21537682 ↗
• MalfunctionNov 21, 2024Erratic or Intermittent Display; Display or Visual Feedback Problem; Erratic or Intermittent Display; Display or Visual Feedback Problem

  A CUSTOMER REPORTED WHILE USING A BFLEX2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE DURING A PATIENT PROCEDURE, THE IMAGE BLACKED OUT. A SECOND BRONCHOSCOPE FROM THE SAME PACKAGE WAS OBTAINED BUT THE IMAGE WAS REPORTED TO FLICKER AND THEN IT ALSO BLACKED IN AND OUT. THE PROCEDURE WAS STILL ABLE TO BE COMPLETED USING THE SECOND BRONCHOSCOPE. NO DELAY IN PROCEDURE OR HARM TO THE PATIENT WAS REPORTED. FOLLOWING THE REPORTED EVENT, THE CUSTOMER'S VERATHON TERRITORY MANAGER EVALUATED THE GLIDESCOPE SYSTEM AT THE USER FACILITY AND REPORTED ISOLATING THE ISSUE TO THE BRONCHOSCOPE INITIALLY USED. THE SECOND BRONCHOSCOPE USED TO FINISH THE PROCEDURE HAD ALREADY BEEN DISCARDED BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20747610 ↗
• MalfunctionNov 6, 2024

  AFTER SET-UP EVERYTHING SEEMED TO BE WORKING FINE. WHEN SCOPE WAS MOVED INTO POSITION TO PLACE IN ETT THE MONITOR SCREEN WENT BLACK. HAS BEEN REPORTED & REP PICKED UP. MANUFACTURER RESPONSE FOR BRONCHOSCOPE (FLEXIBLE OR RIGID), BFLEX¿ (PER SITE REPORTER). REP PICKED UP PRODUCT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20619756 ↗
• MalfunctionJun 13, 2023Erratic or Intermittent Display; Display or Visual Feedback Problem; Erratic or Intermittent Display; Display or Visual Feedback Problem

  A CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE, THE IMAGE ON THE CONNECTED MONITOR KEPT FREEZING. IT WAS REPORTED THAT THE USERS UNPLUGGED THE BRONCHOSCOPE AND CABLES AND RESTARTED THE MONITOR BUT THE ISSUE CONTINUED TO OCCUR. THE FACILITY'S VERATHON TERRITORY MANAGER ASSISTED THE CUSTOMER ONSITE WITH TROUBLESHOOTING AND WAS ABLE TO DUPLICATE THE REPORTED ISSUE WITH THE SUBJECT BRONCHOSCOPE USED DURING THE PROCEDURE BUT COULD NOT DUPLICATE THE ISSUE WHEN USING A NEW GLIDESCOPE BFLEX SINGLE-USE BRONCHOSCOPE. NO DELAY IN THE PROCEDURE, USE OF A BACKUP DEVICE, OR HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17118347 ↗