EXALT™ M0054243R0Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729990932), received between Mar 9, 2023 and Sep 16, 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 16, 2026Optical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793377 ↗
• MalfunctionMay 13, 2026Poor Quality Image

  THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED WITH AN EXALT CONTROLLER DURING AN ERCP PROCEDURE PERFORMED ON (B)(6) 2026, FOR THE TREATMENT OF A CHOLEDOCALLITHIASIS. DURING THE PROCEDURE, THE SCOPE WAS UNABLE TO BE USED DUE TO THE IMAGE COLOR QUALITY WAS POOR, MAKING IT DIFFICULT DELINEATE THE TISSUE FOR CANNULATION. 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 25164357 ↗
• MalfunctionDec 26, 2025Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED IN THE SAME PROCEDURE. IT WAS REPORTED THAT AN EXALT MODEL D CONTROLLER WAS UTILIZED WITH TWO EXALT MODEL D SCOPES ON DURING AN UNKNOWN PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE EXALT IMAGE APPEARED BUT DISAPPEARED AFTER A FEW SECONDS. TROUBLESHOOTING INCLUDED RECONNECTING THE SCOPE TO EXALT CONTROLLER STILL RESULTING IN IMAGE ISSUE. A SECOND EXALT SCOPE WAS TRIED HOWEVER WITH THE SAME RESULTS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT MODEL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898407 ↗
• MalfunctionDec 23, 2025Optical Problem; Optical Problem

  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 CONTROLLER DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SCOPE MALFUNCTIONED AND THE IMAGE WENT BLANK. THE PROCEDURE WAS COMPLETED WITH A REUSABLE SCOPE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881947 ↗
• MalfunctionOct 20, 2025Optical Problem; Unexpected Shutdown; Optical Problem; Unexpected Shutdown

  NOTE: THIS REPORT PERTAINS TO ONE OF EXALT D CONTROLLER DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER: 3005099803-2025-05418 FOR THE FIRST EXALT D CONTROLLER FOR THE SECOND EXALT D CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC THAT THE EXALT MODEL D CONTROLLER WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE THE EXALT MODEL D CONTROLLER POWERED OFF DURING CASE. THE CONTROLLER WAS RESTARTED ON TO MOVE FORWARD WITH CASE. HOWEVER, IT CONTINUED TO POWER OFF. THE ACCOUNT BORROWED AN EXALT CONTROLLER UNIT FROM ANOTHER ROOM TO DISCOVER THE SAME ISSUE. THE ACCOUNT MOVED FORWARD TO SWAP THE POWER CABLE PROVIDED BY BIOMED AND COMPLETED CASE WITH NO PATIENT COMPLICATIONS. THE ACCOUNT PROVIDED REPLACEMENT CABLE TO WORK WITH NO ISSUES. THE ORIGINAL EXALT CONTROLLER WAS REINSTALLED AND TESTED WITH NO POWER ISSUES. PROCEDURE WAS COMPLETED WITH ANOTHER EXALT MODEL D CONTROLLER POWER CABLE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THIS RECORD REPRESENTS THE SECOND EXALT CONTROLLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337385 ↗
• MalfunctionOct 15, 2025Optical Problem; Unexpected Shutdown; Optical Problem; Unexpected Shutdown

  IT WAS REPORTED THAT THE EXALT MODEL D CONTROLLER WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE THE EXALT MODEL D CONTROLLER POWERED OFF DURING CASE. THE CONTROLLER WAS RESTARTED ON TO MOVE FORWARD WITH CASE. HOWEVER, IT CONTINUED TO POWER OFF. THE ACCOUNT BORROWED AN EXALT CONTROLLER UNIT FROM ANOTHER ROOM TO DISCOVER THE SAME ISSUE. THE ACCOUNT MOVED FORWARD TO SWAP THE POWER CABLE PROVIDED BY BIOMED AND COMPLETED CASE WITH NO PATIENT COMPLICATIONS. THE ACCOUNT PROVIDED REPLACEMENT CABLE TO WORK WITH NO ISSUES. PROCEDURE WAS COMPLETED WITH ANOTHER EXALT MODEL D CONTROLLER. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE ORIGINAL EXALT CONTROLLER WAS REINSTALLED AND TESTED WITH NO POWER ISSUES. THIS RECORD REPRESENTS THE ORIGINAL EXALT CONTROLLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303682 ↗
• MalfunctionApr 1, 2025Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2025-01378 FOR THE FIRST EXALT MODEL D SCOPE, NUMBER 3005099803-2025-01377 FOR THE SECOND EXALT MODEL D SCOPE AND REPORT NUMBER FOR THE EXALT MODEL D CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D CONTROLLER WAS USED WITH TWO EXALT MODEL D SCOPES, DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AFTER 10-15 MINUTES THE IMAGE WAS LOST MULTIPLE TIMES. THE EXALT CONTROLLER REBOOTED AND THE IMAGE WOULD RECOVER BUT WITH A PINK IMAGE. ANOTHER SCOPE WAS UTILIZED AND EXPERIENCED THE SAME REPORTED ISSUE. 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 21739296 ↗
• MalfunctionMar 9, 2023Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2023-01115 FOR THE FOR THE EXALT MODEL D SINGLE-USE DUODENOSCOPE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D CONTROLLER WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CHOLEDOCHOLITHIASIS ON (B)(6) 2023. DURING THE PROCEDURE, WHILE USING EXALT MODEL D CONTROLLER, THE EXALT MODEL D ERROR SCREEN WAS DISPLAYED BEFORE THE SCOPE INSERTION INTO THE PATIENT'S ANATOMY. THE SCOPE WAS UNPLUGGED AND PLUGGED BACK, AND THE IMAGE WAS ABLE TO BE REGAINED. HOWEVER, THE DEVICE WAS REINTRODUCED INTO THE PATIENT'S ANATOMY AND THE IMAGE WAS LOST AGAIN. THE SCOPE WAS THEN REMOVED FROM THE PATIENT, AND A REUSABLE SCOPE WAS USED TO COMPLETE THE PROCEDURE WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16512067 ↗