EXALT™ M00542760Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00191506007805), received between Aug 18, 2023 and Aug 13, 2025 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (19 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025Nonstandard Device; Defective Device; Adverse Event Without Identified Device or Use Problem; Optical Problem; Nonstandard Device; Defective Device; Adverse Event Without Identified Device or Use Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN EXALT MODEL B MONITOR WAS USED DURING A PROCEDURE. THE PROCEDURE NAME AND DATE INFORMATION ARE NOT AVAILABLE. DURING THE PROCEDURE, THE EXALT MODEL B MONITOR WAS NOT SHOWING ANY IMAGE WHEN CONNECTING. THE DEVICE WAS SENT TO THE WAREHOUSE BECAUSE IT'S NOT WORKING. THE ISSUE WAS LIKELY DUE TO A BLOW FROM THE IV POLE GIVING WAY OR FALLING OFF THE STAND. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793121 ↗
• MalfunctionFeb 11, 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 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 21358514 ↗
• 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 005099803-2025-00401 FOR THE EXALT MODEL B SCOPE AND REPORT NUMBER 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 21349349 ↗
• MalfunctionJan 24, 2025Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2025-00165 FOR THE EXALT MODEL B SCOPE AND REPORT NUMBER 3005099803-2025-00164 FOR THE EXALT MODEL B MONITOR. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT B MONITOR WAS USED ON (B)(6) 2024. IT WAS OBSERVED THAT THE MONITOR SCREEN GOES DARK AFTER BEING POWERED ON FOR A LONG PERIOD OF TIME. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING A PATIENT INVOLVEMENT, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21233146 ↗
• MalfunctionNov 27, 2024Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL B MONITOR WAS USED DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE EXALT MODEL B MONITOR POWERED DOWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXALT MODEL B MONITOR AND THE SAME 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 20796227 ↗
• MalfunctionOct 30, 2024Overheating of Device; Power Problem; Overheating of Device; Power Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL B MONITOR'S POWER CABLE STOPPED WORKING ON OCTOBER 07, 2024. THE POWER CABLE WAS NOT TRANSMITTING POWER AND WAS SPARKING DUE TO FRAY IN THE CABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20565525 ↗
• MalfunctionSep 23, 2024Overheating of Device; Failure to Power Up; Power Problem; Overheating of Device; Failure to Power Up; Power Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT B MONITOR WAS BEING CHARGED. NO PROCEDURE WAS PERFORMED DURING THAT TIME. WHILE CHARGING, THE POWER SUPPLY CABLE AND THE MONITOR SCREEN BECAME HOT. THE MONITOR AND POWER SUPPLY WERE THEN UNPLUGGED. WHEN THE CHARGING CABLE WAS PLUGGED BACK INTO THE MONITOR, IT WOULDN'T CHARGE. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20279944 ↗
• MalfunctionAug 9, 2024Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-03812 FOR THE EXALT MODEL B SCOPE AND REPORT NUMBER 3005099803-2024-03811 FOR THE EXALT MODEL B CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL B MONITOR WAS USED WITH AN EXALT MODEL B SCOPE DURING A NECK TRAUMA PROCEDURE; THE PROCEDURE DATE IS UNKNOWN. DURING THE PROCEDURE, THE EXALT B MONITOR SHUT OFF. IT THEN WAS TURNED BACK ON. THE MONITOR WAS PLUGGED IN AND CHARGED. IT IS UNKNOWN WHETHER THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL MONITOR OR AN ADDITIONAL EXALT B MONITOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19950470 ↗
• MalfunctionApr 23, 2024Optical Problem; Optical Problem

  IT WAS REPORTED THAT AN EXALT MODEL B MONITOR WAS USED FOR A BRONCHOSCOPY PROCEDURE ON AN UNKNOWN DATE. IT WAS OBSERVED THAT THE EXALT MONITOR WOULD UNEXPECTEDLY SHUT DOWN. NO PATIENT COMPLICATIONS RELATED TO THIS EVENT WERE REPORTED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19163306 ↗
• MalfunctionApr 1, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE AC POWER ADAPTER FOR THE EXALT MODEL B MONITOR WAS GENERATING SMOKE AND SMELLED OF BURNT PLASTIC ON (B)(6) 2024. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19015503 ↗
• MalfunctionMar 25, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT AN EXALT MODEL B MONITOR WAS USED DURING A BRONCHOSCOPY PERFORMED ON (B)(6) 2024, FOR BRONCHIAL LAVAGE. DURING PREPARATION FOR THE PROCEDURE, A STAFF MEMBER NOTICED THAT THE AC POWER ADAPTER FOR THE MONITOR WAS HOT TO THE TOUCH AND ALMOST MELTING. THEY UNPLUGGED THE POWER CABLE FROM THE MONITOR AND THE WALL OUTLET, AND COMPLETED THE PROCEDURE USING THE EXALT B MONITOR UNPLUGGED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE STAFF MEMBER WHO HANDLED THE AC POWER ADAPTER REPORTED EXPERIENCING MINOR PAIN FROM THE HEAT.

  Patient problems: Pain

  MAUDE report 18970981 ↗
• MalfunctionMar 19, 2024Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL B MONITOR WAS USED ON AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PREPARATION FOR THE PROCEDURE, THE AC POWER ADAPTER FOR THE MONITOR WAS BROUGHT INTO PATIENT'S ROOM AND PLUGGED INTO THE WALL. AS IT WAS PLUGGED IN, IT WAS REPORTED THAT FLAMES SHOT OUT OF THE POWER SUPPLY, MELTING PART OF THE POWER SUPPLY AND POWER CORD, AND LEAVING A BLACK RESIDUE ON THE MONITOR STAND. THE AC ADAPTER WAS THEN PROMPTLY REMOVED FROM THE WALL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE ORIGINAL MONITOR. THE FACILITY DISCONTINUED USE OF THE DAMAGED POWER ADAPTER. NO INJURIES, PATIENT COMPLICATIONS, OR OTHER DAMAGE WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18934827 ↗
• MalfunctionMar 14, 2024Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-01051 FOR THE EXALT MODEL B SCOPE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL B SINGLE USE BRONCHOSCOPE WAS USED DURING A BRONCHOSCOPY PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE EXALT MODEL B MONITOR LOST IMAGE. THE SCREEN WENT BLANK. THE MEDICAL STAFF CONFIRMED THAT THE POWER SUPPLY CORD WAS CONNECTED TO THE MONITOR DURING THE EVENT. THEREFORE, A SECOND MONITOR WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL DETAILS, DESPITE GOOD FAITH EFFORTS (GFES).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18905281 ↗
• MalfunctionMar 14, 2024Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-01043 FOR THE EXALT MODEL B SCOPE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL B SINGLE USE BRONCHOSCOPE WAS USED DURING A BRONCHOSCOPY PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE EXALT MODEL B MONITOR LOST IMAGE. THE SCREEN WENT BLANK. THE MEDICAL STAFF CONFIRMED THAT THE POWER SUPPLY CORD WAS CONNECTED TO THE MONITOR DURING THE EVENT. THEREFORE, A SECOND MONITOR WAS USED TO COMPLETE THE PROCEDURE. IT IS UNKNOWN IF THE SAME EXALT MODEL B SCOPE WAS USED WITH THE SECOND MONITOR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL DETAILS, DESPITE GOOD FAITH EFFORTS (GFES).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18903335 ↗
• MalfunctionFeb 22, 2024Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-00542 FOR THE EXALT MODEL B SCOPE, AND 3005099803-2024-00702 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, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18759864 ↗
• MalfunctionFeb 22, 2024Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-00541 FOR THE EXALT MODEL B SCOPE, AND 3005099803-2024-00699 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, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18759855 ↗
• MalfunctionDec 11, 2023Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL B MONITOR WAS USED ON A BED SIDE BRONCHOSCOPY FOR LUNG TRANSPLANT PERFORMED ON (B)(6), 2023. DURING ONE OF THE PROCEDURES, THE TABLET WENT BLACK WHILE THE FAN WAS STILL RUNNING, AND VISUALIZATION WAS LOST. THE ACCOUNT TRIED TO TURN IT OFF AND ON, BUT THE DEVICE DID NOT RESPOND. IMAGE WAS REGAINED AFTER A HARD RESET. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER EXALT B MONITOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18303801 ↗
• MalfunctionOct 24, 2023Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL B MONITOR KIT WAS USED DURING A BRONCHOSCOPY PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE EXALT MODEL B MONITOR STOPPED WORKING CAUSING VISUALIZATION TO BE LOST. THE EXALT MODEL B SCOPE WAS EXCHANGED; HOWEVER, THE ISSUE PERSISTED. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH A REUSABLE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17998650 ↗
• MalfunctionOct 5, 2023Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL B MONITOR KIT WAS USED DURING A BRONCHOSCOPY PROCEDURE FOR BRONCHIAL INSPECTION AND CLEANING UNDER LOCAL ANESTHESIA ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE EXALT MODEL B MONITOR STOPPED WORKING CAUSING VISUALIZATION TO BE LOST. THE PROCEDURE WAS NOT ABLE TO BE COMPLETED AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED THE NEXT DAY WITH A REUSABLE SCOPE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17876540 ↗
• MalfunctionAug 23, 2023Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL B MONITOR KIT WAS USED DURING A BRONCHOSCOPY PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE MONITOR SCREEN WENT BLACK CAUSING VISUALIZATION TO BE LOST. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17603610 ↗
• MalfunctionAug 23, 2023Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL B MONITOR KIT WAS USED DURING A BRONCHOSCOPY PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE MONITOR SCREEN WENT BLACK CAUSING VISUALIZATION TO BE LOST. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17603607 ↗
• MalfunctionAug 23, 2023Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL B MONITOR KIT WAS USED DURING A BRONCHOSCOPY PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE MONITOR SCREEN WENT BLACK CAUSING VISUALIZATION TO BE LOST. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17603560 ↗
• MalfunctionAug 23, 2023Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL B MONITOR KIT WAS USED DURING A BRONCHOSCOPY PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE MONITOR SCREEN WENT BLACK CAUSING VISUALIZATION TO BE LOST. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17603552 ↗
• MalfunctionAug 18, 2023Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT B MONITOR KIT WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE MONITOR POWERED OFF INTERMITTENTLY. NO FURTHER INFORMATION HAS BEEN ABLE TO BE OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17577516 ↗