BFlexRecalls & reported problems across all models

We found 3 models of BFlex by Verathon Medical (Canada) ULC in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Jun 13, 2023 and Aug 14, 2026 — classified as 4 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (10 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 BFlex problems

BFlex models

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

• BFlex™ BFlex™ 2 Regular 5.0

  Bronchoscope (Flexible Or Rigid)
  12 reports
• BFlex™ BFlex™ 2 Large 5.8

  Bronchoscope (Flexible Or Rigid)
  10 reports
• BFlex™ BFlex™ 2 Slim 3.8

  Bronchoscope (Flexible Or Rigid)
  1 report

Recent BFlex adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionApr 7, 2026Material Separation; Material Split, Cut or Torn

  A CUSTOMER REPORTED TO THEIR VERATHON CLINICAL SPECIALIST THAT THE SHEATH OF A BFLEX 2 LARGE 5.8 SINGLE-USE BRONCHOSCOPE TORE DURING A BRONCHOSCOPY PROCEDURE. IT WAS REPORTED THAT THE PATIENT WAS ALREADY INTUBATED WITH A 7.5 SHILEY EVAC ENDOTRACHEAL TUBE (ETT). A SONTEK SUCTION-SAFE Y BODAI SWIVEL ADAPTER WAS PLACED ON TOP OF THE ETT AND THE BRONCHOSCOPE PASSED THROUGH IT TO CLEAN THE PATIENT OUT WHILE ALSO VENTILATING. AFTER REMOVAL OF THE BRONCHOSCOPE, THE USERS REALIZED THERE WAS A SIGNIFICANT TEAR AT THE TIP OF THE BRONCHOSCOPE, EXPOSING THE INTERNAL COMPONENTS. NO DELAY IN PROCEDURE, USE OF A BACKUP, OR HARM TO THE PATIENT WAS REPORTED. FOLLOW-UP INFORMATION RECEIVED BY THE VERATHON CLINICAL SPECIALIST REPORTED THE BRONCHOSCOPE WAS BELIEVED TO HAVE TORN UPON WITHDRAWL FROM THE ETT / BODAI ADAPTER. A CT SCAN WAS PERFORMED WHICH CONFIRMED NO PARTS OF THE BRONCHOSCOPE WERE IDENTIFIED IN THE PATIENT'S LUNGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24810828 ↗
• MalfunctionDec 16, 2025Degraded; Flaked; Material Frayed; Material Deformation; Degraded; Flaked; Material Frayed; Material Deformation

  A CUSTOMER REPORTED THE DISTAL TIP OF A BFLEX 2 LARGE 5.8 SINGLE-USE BRONCHOSCOPE DETERIORATED DURING SUCTIONING THROUGH A 7.5 SHILEY HI-LOW ENDOTRACHEAL TUBE. A BACKUP BFLEX 2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE WAS USED TO COMPLETE ADDITIONAL SUCTIONING AND REMOVAL OF THE DETACHED PIECES. NO ADDITIONAL PULMONARY PROCEDURE WAS REQUIRED AND THE PATIENT WAS CONFIRMED TO BE FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23819009 ↗
• InjuryNov 4, 2025Flaked; Material Frayed; Flaked; Material Frayed

  A CUSTOMER REPORTED THAT A PATIENT WAS INTUBATED USING A BFLEX 2 LARGE 5.8 SINGLE-USE BRONCHOSCOPE WITH A 7.5 MM ENDOTRACHIAL TUBE. AFTER THE INTUBATION, THE BRONCHOSCOPE WAS REMOVED FROM THE PATIENT AND THE WHITE COATING ON THE TIP OF THE BRONCHOSCOPE APPEARED TO HAVE FRAYED OFF. A SUBSEQUENT BRONCHOSCOPY WAS THEN PERFORMED ON THE PATIENT TO REMOVE THE PIECES THAT FELL OFF IN THE LUNGS. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467272 ↗
• 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 ↗
• InjurySep 9, 2025Degraded; Flaked; Peeled/Delaminated; Material Separation; Degraded; Flaked; Peeled/Delaminated; Material Separation

  A CUSTOMER REPORTED AN ISSUE WHILE USING A BFLEX 2 5.8 SINGLE-USE BRONCHOSCOPE DURING A PATIENT PROCEDURE. DURING WITHDRAWAL OF THE BFLEX 2 5.8 SINGLE-USE BRONCHOSCOPE FROM A COVIDIEN 8.0 MM ENDOTRACHEAL TUBE (ETT) WITH A LARGE SWIVEL ADAPTOR IN PLACE, THE OUTER DISTAL SHEATH DELAMINATED, AND THREE FRAGMENTS WERE IDENTIFIED. ONE FRAGMENT ADHERED TO THE ETT TIP AND TWO FRAGMENTS WERE IN THE PATIENT'S UPPER AIRWAY. ALL FRAGMENTS WERE RETRIEVED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23010351 ↗
• 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 ↗
• MalfunctionJun 10, 2025Erratic or Intermittent Display; Display or Visual Feedback Problem; Erratic or Intermittent Display; Display or Visual Feedback Problem

  A CUSTOMER REPORTED THAT DURING A BRONCHOSCOPY, USING A BFLEX 2 LARGE 5.8 SINGLE-USE BRONCHOSCOPE, THE IMAGE WAS BLURRY INITIALLY AND SUBSEQUENTLY WAS COMPLETELY LOST IN THE MIDDLE OF THE PROCEDURE. 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 22178191 ↗
• 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 ↗
• MalfunctionApr 7, 2025Material Twisted/Bent

  B FLEX 2 VERATHON SCOPE COMPLETELY BENT ON ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21786951 ↗
• MalfunctionApr 2, 2025Degraded; Flaked; Material Frayed; Material Deformation; Degraded; Flaked; Material Frayed; Material Deformation

  A CUSTOMER REPORTED A BFLEX 2 LARGE 5.8 SINGLE-USE BRONCHOSCOPE WAS USED FOR A CASE TO REMOVE ZEPHYR VALVES FROM A PATIENT. IT WAS REPORTED THAT THE BRONCHOSCOPE WAS ADVANCED THROUGH A BRONCHOSCOPE ADAPTER AND A SHILEY 8.0 ENDOTRACHEAL (ET) TUBE TO VIEW THE AIRWAY AND RETRIEVE A VALVE FOR REMOVAL. THREE (3) ADDITIONAL PASSES WERE MADE THROUGH THE ET TUBE ONLY FOR VALVE REMOVAL. AT THIS POINT IN THE PROCEDURE, DETERIORATION OF THE BRONCHOSCOPE'S DISTAL TIP WAS OBSERVED. IT WAS REMOVED FROM SERVICE AND SET ASIDE WHILE A NEW BFLEX 2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE WAS USED TO COMPLETE THE VALVE REMOVAL CASE. THERE WERE 3-5 PIECES OF DEBRIS REMOVED FROM THE PATIENT'S AIRWAY VIA FORCEPS. DURING A SECOND PROCEDURE WITH A THORACIC SURGEON USING A NON-VERATHON BRONCHOSCOPE, ADDITIONAL PIECES OF DEBRIS WERE OBSERVED TO BE REMAINING IN THE PATIENT'S AIRWAY. THE ORIGINAL INTERVENTIONAL PULMONOLOGIST AND A RESPIRATORY THERAPIST WERE CALLED BACK TO PERFORM A LAVAGE TO WASH OUT THE REMAINING DEBRIS WITH ANOTHER BFLEX 2 LARGE 5.8 SINGLE-USE BRONCHOSCOPE FROM A DIFFERENT LOT WHICH WAS SUCCESSFULLY COMPLETED. FOLLOWING THE PROCEDURES, THE PATIENT WAS REPORTED TO BE DOING FINE. FOLLOWING THE CUS

  Patient problems: Foreign Body In Patient

  MAUDE report 21755459 ↗

Other Verathon Medical (Canada) ULC products

• GlideScope36 models · 347 reports · 2 recalls