Dreamtome™ Pro RX 44 M00584400Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00191506039240), received between Aug 6, 2024 and Sep 10, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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 10, 2026Difficult to Advance; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716932 ↗
• MalfunctionSep 9, 2026Use of Device Problem; Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695465 ↗
• MalfunctionJul 21, 2026Break; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25892857 ↗
• MalfunctionApr 29, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME PRO RX 44 WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, A SPHINCTEROTOME BROKE. THEY HAD HARDLY USED IT TO CUT WHEN THE WIRE BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE WAS DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25037059 ↗
• MalfunctionMar 9, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME PRO RX 44 WAS ATTEMPTED TO BE USED DURING A SPHINCTEROTOMY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUTTING WIRE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545564 ↗
• MalfunctionAug 19, 2025Material Protrusion/Extrusion

  FROM STAFF: PATIENT WAS HAVING A ERCP [ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY] WITH DR [REDACTED]. DURING THE PROCEDURE THE WIRE WAS EXPOSED THROUGH THE WIRE COVERING. PATIENT WASN'T HARMED NOR DAMAGE TO THE SCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22838133 ↗
• MalfunctionNov 5, 2024Failure to Align; Failure to Align

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME PRO RX 44 SPHINCTEROTOME WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, AFTER BOWING THE TOME, IT BECAME UNABLE TO BE RELAXED AND REMAINED STUCK IN THE BOWED POSITION. THE NURSE DOES NOT BELIEVE IT WAS CAUGHT ON THE SCOPE OR ELEVATOR, AND DESPITE SEVERAL ATTEMPTS, SHE WAS UNABLE TO RELAX THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DREAMTOME PRO RX 44 SPHINCTEROTOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20605895 ↗
• MalfunctionAug 6, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME PRO RX 44 SPHINCTEROTOME WAS USED IN THE MAJOR PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CUTTING WIRE OF SNAPPED DURING THE SPHINCTEROTOMY AND "THE WIRE APPEARS TO HAVE BEEN SEPARATED FROM THE BLUE INSULATED SECTION." IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19915193 ↗