EXALT™ Model B M00542730Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00191506007454), received between Oct 5, 2023 and Feb 10, 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.

• MalfunctionFeb 10, 2025Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER . FOR THE EXALT MODEL B SCOPE AND REPORT NUMBER 3005099803-2025-00402 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 UNKNOWN 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 21349352 ↗
• MalfunctionFeb 20, 2024Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL B MONITOR WAS USED WITH AN EXALT MODEL B SCOPE, REGULAR DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE MONITOR SCREEN WENT BLACK AND VISUALIZATION WAS LOST. THE PHYSICIAN SWITCHED TO A SECOND EXALT MODEL B MONITOR AND A NEW EXALT MODEL B SCOPE TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED (THREE SCOPES AND ONE MONITOR). REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-00540 FOR THE FIRST EXALT MODEL B SCOPE, 3005099803-2024-00541 FOR THE SECOND EXALT MODEL B SCOPE, 3005099803-2024-00542 FOR THE THIRD EXALT MODEL B SCOPE AND 3005099803-2024-00478 FOR THE EXALT MODEL B MONITOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738477 ↗
• MalfunctionFeb 20, 2024Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL B MONITOR WAS USED WITH AN EXALT MODEL B SCOPE, REGULAR DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE MONITOR SCREEN WENT BLACK AND VISUALIZATION WAS LOST. THE PHYSICIAN SWITCHED TO A SECOND EXALT MODEL B MONITOR AND A NEW EXALT MODEL B SCOPE TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED (THREE SCOPES AND ONE MONITOR). REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-00540 FOR THE FIRST EXALT MODEL B SCOPE, 3005099803-2024-00541 FOR THE SECOND EXALT MODEL B SCOPE, 3005099803-2024-00542 FOR THE THIRD EXALT MODEL B SCOPE AND 3005099803-2024-00478 FOR THE EXALT MODEL B MONITOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738466 ↗
• MalfunctionFeb 20, 2024Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL B MONITOR WAS USED WITH AN EXALT MODEL B SCOPE, REGULAR DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE MONITOR SCREEN WENT BLACK AND VISUALIZATION WAS LOST. THE PHYSICIAN SWITCHED TO A SECOND EXALT MODEL B MONITOR AND A NEW EXALT MODEL B SCOPE TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED (THREE SCOPES AND ONE MONITOR). REFER TO MANUFACTURER REPORT NUMBER (B)(4)FOR THE FIRST EXALT MODEL B SCOPE, (B)(4) FOR THE SECOND EXALT MODEL B SCOPE, 3(B)(4) FOR THE THIRD EXALT MODEL B SCOPE AND (B)(4) FOR THE EXALT MODEL B MONITOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738465 ↗
• MalfunctionJan 12, 2024Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A REGULAR EXALT MODEL B SCOPES WAS USED DURING A BEDSIDE BRONCHOSCOPY PERFORMED ON AN UNKNOWN DATE. AFTER FIVE MINUTES OF USE, THE SCOPE'S IMAGE WAS LOST. THE PROCEDURE WAS UNABLE TO BE COMPLETED AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18505068 ↗
• MalfunctionNov 15, 2023Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL B SINGLE-USE BRONCHOSCOPE, REGULAR WAS USED IN A BRONCHOSCOPY PERFORMED ON (B)(6). 2023. DURING THE BRONCHOSCOPY, WHILE THE SCOPE WAS INSERTED IN THE PATIENT, THE SCOPE ERROR MESSAGE APPEARED AND THEN IMAGE WAS REGAINED FOR A BRIEF PERIOD BEFORE VISUALIZATION TO THE EXALT B MONITOR WAS COMPLETELY LOST AND COULD NOT BE REGAINED. THE PHYSICIAN THEN REMOVED THE SCOPE FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER SINGLE-USE BRONCHOSCOPE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18141346 ↗
• MalfunctionOct 5, 2023Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL B SCOPE, REGULAR WAS USED ON A BRONCHOSCOPY PROCEDURE ON UNKNOWN DATE. IT WAS REPORTED THAT DURING THE PROCEDURE THE IMAGE OF THE EXALT B SCOPE WAS LOST. THE SCOPE WAS EXCHANGED FOR ANOTHER EXALT MODEL B SCOPE, AND THE PROCEDURE WAS ABLE TO BE COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17876779 ↗