EXALT Model DRecalls & reported problems across all models

We found 2 models of EXALT Model D by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 290 adverse event reports in the FDA's MAUDE database, received between Jul 29, 2020 and Sep 1, 2026 — classified as 2 deaths, 47 injuries, 241 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (169 reports).

6 FDA recall records name at least one of these models by its device identifier, 6 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. 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 Model D 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. Sep 27, 2023Open, Classified

   Poor image quality due to fluid ingress in the lens.

   Z-0397-2024 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

2. Sep 27, 2023Open, Classified

   Poor image quality due to fluid ingress in the lens.

   Z-0396-2024 · Root cause: Process control · names 2 of these models · Recall details · 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-1082-2022 · Root cause: Device Design · Recall details · 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-1081-2022 · Root cause: Device Design · Recall details · FDA record ↗

5. 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 · Recall details · FDA record ↗

6. 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 · Recall details · FDA record ↗

Most reported EXALT Model D problems

EXALT Model D models

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

• EXALT™ Model D M00542420

  Duodenoscope and accessories, flexible/rigid
  4 recalls1 death252 reports
• EXALT™ Model D M0054242CE0

  Duodenoscope and accessories, flexible/rigid
  4 recalls1 death38 reports

Recent EXALT Model D adverse event reports

The 15 most recent reports across all models, 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 ↗

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