EXALT™ M0054243Z0Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729990956), received between Nov 15, 2024 and Sep 1, 2026 — classified as 8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Fitting Problem; Optical Problem; Unexpected Shutdown

  Note: This report pertains to one of two devices used in the same procedure.It was reported to Boston Scientific Corporation that an EXALT Model D Scope was used with an EXALT Model D Controller during an endoscopic retrograde cholangiopancreatography (ERCP) procedure on (b)(6)2026, for the treatment of bile duct stones.During the procedure, after 10 minutes inside the patient, the screen flickered then returned to normal; and after about another 5 minutes the screen became fuzzy. Troubleshooting was performed, including powering off and restarting the controller; however, the issue persisted. Unhooking the scope's umbilicus from the controller was reported to be difficult, and after plugging it back in the controller unexpectedly shutdown while rebooting. The controller was turned back on and while it was rebooting, it shut down again. Due to this, the procedure was completed with a different model device.It was reported to be difficult to remove the scope umbilicus from the controller. Per the user, the tab to release the scope did not appear to be functioning properly.No patient complications or adverse effects were reported in relation to this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50534785 ↗
• MalfunctionJul 7, 2026Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT CONTROLLER WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE THE IMAGE WOULD FLICKER CAUSING LOSS OF VISUALIZATION. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25740456 ↗
• MalfunctionJul 7, 2026Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT CONTROLLER WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE THE IMAGE WOULD FLICKER CAUSING LOSS OF VISUALIZATION. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25740450 ↗
• MalfunctionJul 7, 2026Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT CONTROLLER WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE THE IMAGE WOULD FLICKER CAUSING LOSS OF VISUALIZATION. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25740444 ↗
• MalfunctionJul 7, 2026Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A EXALT CONTROLLER WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THERE WAS INTERMITTENT LOSS OF VISUALIZATION. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25740441 ↗
• MalfunctionJul 16, 2025Optical Problem; Unexpected Shutdown; Optical Problem; Unexpected Shutdown

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2025-03307 FOR EXALT MODEL D SCOPE AND FOR THE EXALT CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT CONTROLLER WAS USED DURING A DIAGNOSIS PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE IMAGE WAS LOST AND THE EXALT CONTROLLER UNEXPECTEDLY REBOOTED. THE PROCEDURE WAS COMPLETED USING A SECOND EXALT MODEL D SCOPE AND THE ORIGINAL EXALT CONTROLLER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521741 ↗
• MalfunctionMay 14, 2025Poor Quality Image; Poor Quality Image

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2025-02078 FOR EXALT MODEL D SCOPE AND 3005099803-2025-02206 FOR THE EXALT MODEL D CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED WITH AN EXALT MODEL D CONTROLLER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE IMAGE WAS BLURRY AND COULD NOT BE CLEARED WITH IRRIGATION. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE, A REUSABLE SCOPE WAS USED FOR VERIFICATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021329 ↗
• MalfunctionNov 15, 2024Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-05843 FOR THE EXALT MODEL D SCOPE AND REPORT NUMBER 3005099803-2024-05842 FOR THE EXALT MODEL D CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D CONTROLLER WAS USED WITH AN EXALT MODEL D SCOPE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, A SCOPE ERROR MESSAGE APPEARED. THE PROCEDURE WAS COMPLETED WITH A REUSABLE SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694287 ↗