Autotome™ Pro RX 44 M00584380Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00191506039226), received between Mar 7, 2024 and Mar 5, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME PRO RX 44 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CUTTING WIRE WAS FRACTURED WHEN DOING SPHINCTEROTOMY. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24527095 ↗
• MalfunctionSep 19, 2025Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME PRO RX 44 WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE BROKE, HINDERING ITS REMOVAL THROUGH THE WORKING CHANNEL OF THE DUODENOSCOPE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23092788 ↗
• MalfunctionAug 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME PRO RX 44 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT GALLSTONES PERFORMED ON (B)(6) 2025. DURING THE PREPARATION, THE PACKAGE WAS OPENED, AND IT WAS OBSERVED THAT THE CUTTING WIRE WAS LOOSE, MAKING THE DEVICE IMPOSSIBLE TO USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WAS PROVIDED BY THE CUSTOMER AND SHOWED THE WIRE/ANCHOR WAS DISLODGED FROM THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22785887 ↗
• MalfunctionJun 24, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME PRO RX 44 WAS ATTEMPTED TO BE USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILIARY STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AFTER THE PHYSICIAN SUCCESSFULLY CANNULATED WITH THE AUTOTOME AND DREAMWIRE. THE PHYSICIAN WAS IN A POSITION TO PERFORM THE SPHINCTEROTOMY. AFTER THE TECH BOWED THE TOME AND THE PHYSICIAN STARTED TO MAKE THE CUT, THE CUT WIRE BROKE AT THE PROXIMAL END (AWAY FROM THE TIP OF THE SCOPE) WHERE IT ATTACHES TO THE SCOPE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THE COMPLAINANT REPORTED THAT THE EXPOSED CUTTING WIRE WAS NOT FULLY EXITED THE ENDOSCOPE WHEN THE DEVICE WAS ENERGIZED; HOWEVER, ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), WARNING: VERIFY THAT THE CUTTING WIRE HAS EXITED THE ENDOSCOPE BY VISUALIZING IT ON THE ENDOSCOPE MONITOR. FAILURE TO DO SO MAY RESULT IN CONTACT BETWEEN THE CUTTING WIRE AND THE ENDOSCOPE WHILE ELECTRICAL CURRENT IS APPLIED. THIS M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318801 ↗
• MalfunctionMar 7, 2024Break; Use of Device Problem; Material Deformation; Break; Use of Device Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME PRO RX 44 CANNULATING SPHINCTEROTOME WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING SPHINCTEROTOMY PROCEDURE, IT WAS NOTICED THAT THE PAPILLA WAS VERY LOW HANGING, AND THEN THE CUTTING WIRE OF THE DEVICE BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE DEVICE WAS REMOVED, AND 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 18861845 ↗