EXALT™ Model B M00542750Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00191506007485), received between Jan 4, 2024 and Oct 30, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2025Optical Problem; Optical Problem

  IT WAS REPORTED THAT AN EXALT MODEL B SCOPE WAS UTILIZED DURING A TRACHEOSTOMY PROCEDURE ON (B)(6) 2025, FOR THE TREATMENT OF AN OBSTRUCTED AIRWAY. DURING THE PROCEDURE, VISUALIZATION WAS LOST. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXALT MODEL B SCOPE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424992 ↗
• MalfunctionFeb 12, 2025Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2025-00405 FOR THE EXALT MODEL B SCOPE AND REPORT NUMBER 3005099803-2025-00403 FOR THE EXALT MODEL B MONITOR. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL B MONITOR WAS USED WITH AN EXALT MODEL B SCOPE DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON AN UNKNOW DATE, RELATED TO A TRACHEOSTOMY. DURING THE PROCEDURE, THE HOME SCREEN CAME BACK ONTO THE MONITOR AND THE SCOPE WAS NOT ABLE TO RECONNECT. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXALT MODEL B SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21365427 ↗
• MalfunctionMar 21, 2024Optical Problem; Optical Problem

  IT WAS REPORTED THAT AN EXALT MODEL B SINGLE USE SCOPE WAS USED DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024 FOR TREATMENT OF CENTRAL AIRWAY OBSTRUCTION. DURING THE PROCEDURE, WHILE THE SCOPE WAS INSIDE THE PATIENT'S AIRWAY, THE IMAGE WAS LOST AND THE SCOPE ERROR SCREEN DISPLAYED. THE NURSE TRIED UNPLUGGING AND PLUGGING THE SCOPE BACK IN, BUT THE IMAGE WAS NOT RECOVERED. THE PROCEDURE AS COMPLETED WITH A SECOND EXALT SCOPE. THERE WERE NO PATIENT COMPLICATIONS RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18950453 ↗
• MalfunctionJan 29, 2024Optical Problem; Optical Problem

  IT WAS REPORTED THAT AN EXALT MODEL B SINGLE USE SCOPE WAS USED DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE ON(B)(6) 2024. DURING THE PROCEDURE, VISUALIZATION WAS LOST AND LINES DISPLAYED ACROSS THE SCREEN. THE SCOPE WAS UNPLUGGED AND PLUGGED BACK IN, BUT VISUALIZATION WAS NOT REGAINED. ANOTHER EXALT MODEL B SCOPE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18602704 ↗
• MalfunctionJan 18, 2024Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL B SCOPE WAS USED ON A PERCUTANEOUS TRACHEOSTOMY PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE THE SCOPE IMAGE WENT OUT AND THE SCREEN WENT BLACK, NO IMAGE OR ERROR MESSAGE WAS DISPLAYED. THEY UNPLUGGED AND PLUGGED THE SCOPE BACK IN, THERE WAS STILL NO IMAGE. THE PROCEDURE WAS COMPLETED USING ANOTHER EXALT MODEL B SCOPE. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18535383 ↗
• MalfunctionJan 18, 2024Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL B SCOPE WAS USED ON A BRONCHOSCOPY FOR DIAGNOSTIC PURPOSES ON (B)(6) 2023. DURING THE PROCEDURE, THE SCREEN WENT BLACK. THE SCOPE WAS UNPLUGGED AND PLUGGED BACK IN BUT VISUALIZATION COULD NOT BE REGAINED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER EXALT MODEL B SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18535230 ↗
• MalfunctionJan 4, 2024Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL B SCOPE WAS USED ON A BRONCHOSCOPY PERFORMED IN ORDER TO OBTAIN A SAMPLE FOR THE DIAGNOSIS OF CYSTIC FIBROSIS PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEN THE SCOPE WAS IN THE RIGHT MAIN BRONCHUS, THE IMAGE STOPPED SHOWING ON THE SCREEN. THE DEVICE WAS PLUGGED IN AND OUT OF THE MONITOR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE. HOWEVER, THE SAMPLE COULD NOT BE OBTAINED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18443308 ↗