BFlex™ BFlex™ 2 Large 5.8Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00879123008572), received between Dec 10, 2024 and Apr 7, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Flaked” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Material Separation; Material Split, Cut or Torn

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

  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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ADVANCED THROUGH A 7.5 SHILEY ENDOTRACHEAL (ET) TUBE AFTER BEING SPRAYED WITH SILKO SPRAY. WHILE ADVANCED, NO RESISTANCE WAS FELT. THE BRONCHOSCOPE WAS REMOVED FROM THE ET TUBE TO WIPE OFF A PIECE OF ASPIRATED FOOD FROM THE END OF THE BRONCHOSCOPE. NO RESISTANCE WAS FELT WHILE REMOVING THE SCOPE FROM THE ET TUBE. ONCE REMOVED, IT WAS IDENTIFIED THAT THE OUTER SHEATH NEAR THE TIP OF THE BRONCHOSCOPE WAS FRAYING AND COMING LOOSE. A NEW BFLEX 2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT NO DEBRIS WAS DISCOVERED IN THE AIRWAY, NO MEDICAL INTERVENTION WAS REQUIRED, AND THERE WAS NO ADVERSE OUTCOME FOR THE PATIENT. FOLLOWING THE CUSTOMER'S NOTIFICATION TO VERATHON OF THIS EVENT, VERATHON RECEIVED THE FACILITY'S MEDSUN REPORT NUMBER (B)(4) FOR THIS EVENT ON MARCH 17, 2025, WHICH INDICATED THAT THE BRONCHOSCOPES WERE USED FOR A BRONCHOSCOPY TO RE-EVALUATE THE PATIENT'S AIRWAY FOR RESIDUAL FOOD CONTENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21755445 ↗
• MalfunctionMar 6, 2025Erratic or Intermittent Display; Display or Visual Feedback Problem; Erratic or Intermittent Display; Display or Visual Feedback Problem

  A CUSTOMER REPORTED WHILE USING A BFLEX 2 LARGE 5.8 SINGLE-USE BRONCHOSCOPE DURING A BEDSIDE BRONCHOSCOPY, THE IMAGE ON THE CONNECTED GLIDESCOPE CORE MONITOR FROZE FOUR SEPARATE TIMES. THE BRONCHOSCOPE WAS REPLACED AND THE PROCEDURE PROCEEDED WITHOUT INCIDENT. NO DELAY IN PROCEDURE OR HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21537679 ↗
• MalfunctionJan 28, 2025Erratic or Intermittent Display; Display or Visual Feedback Problem; Erratic or Intermittent Display; Display or Visual Feedback Problem

  A CUSTOMER REPORTED WHILE USING A BFLEX 2 LARGE 5.8 SINGLE-USE BRONCHOSCOPE, THE IMAGE ON THE CONNECTED GLIDESCOPE CORE 15-INCH FHD MONITOR DISAPPEARED IN THE MIDDLE OF INTUBATION. THE BRONCHOSCOPE WAS REPLACED WITH A BRIEF DELAY AND THE PROCEDURE PROCEEDED WITHOUT INCIDENT. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252945 ↗
• MalfunctionDec 10, 2024Erratic 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 ON THE CONNECTED GLIDESCOPE CORE 15-INCH MONITOR FROZE. THE BRONCHOSCOPE WAS IMMEDIATELY REPLACED AND THE PROCEDURE PROCEEDED WITHOUT INCIDENT. NO DELAY IN THE PROCEDURE OR HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20895789 ↗