EXALT™ Model D M00542420Recalls & reported problems

Summary

The FDA's MAUDE database contains 252 adverse event reports that list this exact device (DI 08714729983514), received between Jul 29, 2020 and Sep 1, 2026 — classified as 1 death, 42 injuries, 209 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (149 reports).

4 FDA recall records name this device's identifier, 4 still open.

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.

Recalls naming this device

1. Sep 27, 2023Open, Classified

   Poor image quality due to fluid ingress in the lens.

   Z-0397-2024 · Root cause: Process control · FDA record ↗

2. Sep 27, 2023Open, Classified

   Poor image quality due to fluid ingress in the lens.

   Z-0396-2024 · Root cause: Process control · FDA record ↗

3. Mar 3, 2022Open, Classified

   Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.

   Z-1080-2022 · Root cause: Device Design · FDA record ↗

4. Mar 3, 2022Open, Classified

   Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.

   Z-1079-2022 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 252 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Fitting Problem; Optical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50550074 ↗
• InjuryAug 17, 2026Optical Problem

  It was reported to Boston Scientific Corporation that an EXALT MODEL D Scope was utilized in an Endoscopic retrograde cholangiopancreatography (ERCP) procedure on (b)(6) 2026, for the treatment of Cholangitis and stricture in the common bile duct. During the procedure, plastic stent placement was being performed. EXALT MODEL D Scope visualization was lost and the monitor displayed the loading screen followed by the scope error icon. While troubleshooting, the patient became unstable and coded. Due to the patient's condition and a platelet shortage, the procedure was not able to be completed.

  Patient problems: Cardiac Arrest

  MAUDE report 50284728 ↗
• MalfunctionAug 12, 2026Optical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50217373 ↗
• MalfunctionAug 6, 2026Poor Quality Image; Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161440 ↗
• MalfunctionAug 3, 2026Optical Problem

  It was reported to Boston Scientific that an EXALT Model D Single-Use Duodenoscope was utilized during an Endoscopic Retrograde Cholangiopancreatography (ERCP) on (b)(6) 2026 for the treatment of gall stones. During the procedure, the physician passed the Exalt scope into the duodenum and upon attempting to canulate, visualization was lost and blue screen appeared. The scope was replaced with another Exalt and the procedure was completed. No patient complications were reported as a result of the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50116401 ↗
• MalfunctionJul 20, 2026Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AND EXALT MODEL D SCOPE WAS UTILIZED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (b)(6) 2026 FOR THE TREATMENT OF A BILIARY STRUCTURE. DURING THE PROCEDURE, THE EXALT MODEL D SCOPE IMAGE WAS LOST. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25880760 ↗
• MalfunctionJul 20, 2026Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A EXALT MODEL D WAS USED DURING A LAP ASSISTED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026 FOR THE TREATMENT OF STONES. DURING THE PROCEDURE, AFTER 25 MINUTES VISUALIZATION WAS LOST. THE PROCEDURE WAS COMPLETED WITH COMPLETED WITH A NEW EXALT SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25874033 ↗
• MalfunctionJul 17, 2026Poor Quality Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25860686 ↗
• 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 25661270 ↗
• MalfunctionJun 9, 2026Fluid/Blood Leak; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A EXALT MODEL D WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6) 2026 FOR AN UNKNOWN TREATMENT. DURING THE PROCEDURE, CLOSE TO THE END THE VISUALIZATION WAS LOST. IT WAS REPORTED FLUID WAS NOTED EXITING THROUGH THE BIOPSY CAP DURING THE CASE. 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 25451110 ↗
• MalfunctionMay 27, 2026Poor Quality Image

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A EXALT MODEL D SCOPE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026 FOR THE TREATMENT OF STONES. DURING THE PROCEDURE, THE SCOPE WAS INSERTED; HOWEVER, A SMUDGE WAS NOTED ON THE LENS, RESULTING IN IMPAIRED VISUALIZATION. DUE TO POOR VISIBILITY, THE SCOPE COULD NOT BE UTILIZED FOR THE PROCEDURE. 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 25305928 ↗
• MalfunctionMay 19, 2026Poor Quality Image

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6) 2026 FOR THE TREATMENT OF BILIARY STONES. DURING THE PROCEDURE THE IMAGE BEGAN TO DISPLAY A HONEYCOMB PATTERN. 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 25221761 ↗
• MalfunctionMay 12, 2026Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A EXALT MODEL D SCOPE WAS USED 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 25150143 ↗
• MalfunctionMay 12, 2026Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A EXALT MODEL D SCOPE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026 FOR AN UNKNOWN TREATMENT. DURING THE PROCEDURE, THE IMAGE WAS LOST. 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 25150115 ↗
• MalfunctionMay 5, 2026Poor Quality Image; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6) 2026, FOR THE TREATMENT OF PRIMARY SCLEROSING CHOLANGITIS. DURING THE PROCEDURE, THE IMAGE CUT OUT AND BECAME DISTORTED, TROUBLESHOOTING INCLUDED UNPLUGGING AND RECONNECTING THE SCOPE, BUT THE CONTROLLER THEN POWERED DOWN, AND THE IMAGE DID NOT RETURN. 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 25082288 ↗
• MalfunctionApr 29, 2026Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A EXALT MODEL D SCOPE WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, VISUALIZATION WAS LOST WHEN TURNING THE SCOPE'S ARTICULATION KNOB WAS USED. THE PROCEDURE WAS COMPLETED WITH A NEW EXALT MODEL D. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25032236 ↗
• MalfunctionApr 1, 2026Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A EXALT MODEL D WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2026 FOR THE TREATMENT OF PANCREATIC CYSTS & INTRADUCTAL PAPILLARY MUCINOUS NEOPLASM (IPNM) DURING THE PROCEDURE, VISUALIZATION WAS LOST AS THE PHYSICIAN ATTEMPTED TO CANNULATE. THE PROCEDURE WAS COMPLETED WITH A SECOND 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 24756606 ↗
• MalfunctionMar 19, 2026Poor Quality Image

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D EXALT MODEL D SCOPE WAS USED FOR A ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE SCOPE MALFUNCTIONED CAUSING POOR QUALITY VISUALIZATION. THE VISUAL FEED REPEATEDLY BECAME BLURRY AND MOVED IN AND OUT OF FOCUS, MAKING IT DIFFICULT TO MAINTAIN A CLEAR AND CONSISTENT VIEW. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637867 ↗
• MalfunctionMar 12, 2026Poor Quality Image

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON AN UNKNOWN DATE, FOR A REMOVAL OF A STENT. DURING THE PROCEDURE THE IMAGE BEGAN TO DISPLAY A HONEYCOMB PATTERN. 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 24582508 ↗
• MalfunctionFeb 19, 2026Leak/Splash; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A EXALT MODEL D WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026, FOR THE TREATMENT OF STONES. DURING THE PROCEDURE, WATER BEGAN LEAKING WHERE SCOPE CONNECTS TO EXALT CONTROLLER AND CONTINUED TO UNTIL IMAGE WAS LOST. THE PROCEDURE WAS COMPLETED WITH A REUSABLE DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387938 ↗
• MalfunctionFeb 9, 2026Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SINGLE-USE DUODENOSCOPE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026, FOR THE TREATMENT OF STONES. DURING THE PROCEDURE THE SCOPE WAS INTRODUCED TO THE DUODENUM AND THE PATIENT WAS CANNULATED. AFTER A GUIDEWIRE WIRE WAS ADVANCED INTO THE DUCT, VISUALIZATION WAS LOST. THE CONTROLLER WAS POWER CYCLED, AND THE SCOPE WAS UNPLUGGED. VISUALIZATION WAS NOT REGAINED. A SECOND EXALT MODEL D SCOPE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299734 ↗
• MalfunctionFeb 3, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SINGLE-USE DUODENOSCOPE WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6) 2026 FOR TREATMENT OF CHOLANGIOCARCINOMA. DURING PREPARATION FOR THE PROCEDURE, THE NURSE OPENED THE EXALT MODEL D SCOPE AND UNKNOWN SPOTS WERE OBSERVED ON THE INTERIOR PACKAGING. THE SCOPE WAS SUCCESSFULLY USED TO COMPLETE PROCEDURE. THERE WAS NO REPORTED PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251909 ↗
• MalfunctionJan 28, 2026Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE SCOPE FUNCTIONED PROPERLY FOR MOST OF THE CASE BUT EVENTUALLY VISUALIZATION WAS LOST AND THE LOADING SCREEN APPEARED. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202437 ↗
• MalfunctionJan 13, 2026Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE SCOPE MALFUNCTIONED AFTER APPROXIMATELY 30 MINUTES OF NORMAL OPERATION, DISPLAYED AN ERROR ICON WITH A WHITE SCOPE AND EXCLAMATION MARK, RESULTING IN LOSS OF VIDEO OUTPUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXALT MODEL D. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24058183 ↗
• MalfunctionJan 8, 2026Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PATIENT WAS NOTED TO HAVE A CHALLENGING ANATOMY DUE TO A PANCREATIC MASS. THE PHYSICIAN REPORTED MUCOSAL TRAUMA AND BLEEDING CAUSED BY THE SCOPE. THE PHYSICIAN DISCONTINUED THE PROCEDURE. THERE WAS NO PERFORATION. THERE WAS NO INTERVENTION NEEDED FOR THE MUCOSAL TRAUMA OR BLEED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 24014462 ↗