EXALTRecalls & reported problems across all models

We found 6 models of EXALT by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 82 adverse event reports in the FDA's MAUDE database, received between Dec 19, 2022 and Sep 16, 2026 — classified as 82 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (74 reports).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

EXALT recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 16, 2021Class IIITerminated

   May have been programmed with a less than optimal brightness setting resulting in a darker than desired image

   Z-1492-2021 · Root cause: Process control · Recall details · FDA record ↗

Most reported EXALT problems

EXALT models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EXALT™ M00542430

  Endoscopic video imaging system/component, gastroenterology-urology
  1 recall38 reports
• EXALT™ M00542760

  Bronchoscope (flexible or rigid)
  24 reports
• EXALT™ M0054243R0

  Endoscopic video imaging system/component, gastroenterology-urology
  8 reports
• EXALT™ M0054243Z0

  Endoscopic video imaging system/component, gastroenterology-urology
  8 reports
• EXALT™ M0054276Z0

  Bronchoscope (flexible or rigid)
  3 reports
• EXALT™ M0054276R0

  Bronchoscope (flexible or rigid)
  1 report

Recent EXALT adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• MalfunctionJun 29, 2026Optical 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 ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026 FOR THE TREATMENT OF A BILIARY OBSTRUCTION. 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 25661271 ↗
• MalfunctionMay 15, 2026Adverse Event Without Identified Device or Use Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED WITH AN EXALT D CONTROLLER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026, FOR AN UNKNOWN TREATMENT. DURING THE PROCEDURE, IMAGE WAS LOST INTERMITTENTLY. THE PROCEDURE WAS COMPLETED WITH A NEW EXALT MODEL D SCOPE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25186860 ↗
• 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 ↗
• MalfunctionJan 9, 2026Optical Problem

  NOTE: THIS REPORT PERTAINS TO AN EXALT D CONTROLLER USED WITH TWO EXALT MODEL D SCOPES IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO EXALT MODEL D SCOPES WERE USED WITH AN EXALT CONTROLLER DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SCOPE MALFUNCTIONED AND THE IMAGE APPEARS FOR A FEW SECONDS AND THEN BLACKED OUT. A SECOND EXALT SCOPE WAS USED AND THE SAME MALFUNCTION OCCURRED. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JANUARY 14, 2026 CONFIRMING THAT THE PROCEDURE DATE WAS (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24021218 ↗
• MalfunctionJan 8, 2026Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D CONTROLLER WAS USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE EXALT MODEL D CONTROLLER THE CUSTOMER REPORTED THE IMAGE FLICKER, TURNED TO BLACK AND LATER WAS RESTORED. THIS EVENT OCCURRED ONE TO TWO TIMES DURING THE PROCEDURE. PROCEDURE WAS COMPLETED WITH THE ORIGINAL EXALT D CONTROLLER AND EXALT D SCOPE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24012196 ↗
• 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 ↗
• MalfunctionDec 12, 2025Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN EXALT MODEL D CONTROLLER WAS USED WITH AN EXALT MODEL D SCOPE IN A PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, VISUALIZATION WAS LOST. THE EXALT CONTROLLER WAS RESTARTED AND VISUALIZATION RETURNED. TROUBLESHOOTING DETERMINED THAT RECONNECTING A VIDEO CABLE RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXALT MODEL D SCOPE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23792293 ↗
• MalfunctionNov 26, 2025Optical Problem; Unexpected Shutdown; Optical Problem; Unexpected Shutdown

  THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2025-06440 FOR THE EXALT MODEL D SCOPE AND 3005099803-2025-06220 FOR THE EXALT D CONTROLLER. IT WAS REPORTED THAT AN EXALT MODEL D SCOPE WAS USED WITH AN EXALT D CONTROLLER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE EXALT CONTROLLER SHUTDOWN AND VISUALIZATION WAS LOST. THE PROCEDURE WAS COMPLETED WITH A REUSABLE SCOPE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23655714 ↗

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