Autotome™ Pro RX 39 M00584390Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00191506039233), received between Sep 18, 2024 and Sep 12, 2026 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2026Failure to Align

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50744705 ↗
• MalfunctionMar 26, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME PRO RX 39 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUT WIRE BROKE PRIOR TO PERFORM SPHINCTEROTOMY. IT WAS REPORTED THAT THE WIRE WAS INTACT BEFORE BEING ADVANCED THROUGH THE WORKING CHANNEL. THE TOME WAS PREPARED CORRECTLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700168 ↗
• MalfunctionOct 3, 2025Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME PRO RX 39 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUT WAS MADE APPROPRIATELY AND THEN THE CUTTING WIRE BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23213256 ↗
• MalfunctionSep 9, 2025Deformation Due to Compressive Stress; Material Deformation; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME PRO RX 39 WAS ATTEMPTED TO BE USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE WAS BENT. 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 23010632 ↗
• MalfunctionApr 4, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT AN AUTOTOME PRO RX 39 WAS PREPARED FOR USE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PREPARATION, THE DEVICE WAS INSPECTED PRIOR TO USE, AND THEY SAW A HAIR INSIDE THE UNOPENED PACKAGE. THE PROCEDURE WAS COMPLETED WITH A SECOND AUTOTOME PRO RX 39. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21779765 ↗
• MalfunctionNov 15, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME PRO RX 39 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE EVENT DATE WAS REPORTED AS AUGUST 2024. DURING THE PROCEDURE, THE WIRE SNAPPED. 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 20695963 ↗
• MalfunctionSep 18, 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 AN AUTOTOME PRO RX 39 CANNULATING SPHINCTEROTOME WAS ATTEMPTED TO BE USED IN THE SPHINCTER OF ODDI DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE DEVICE WAS PREPARED AND INSERTED INTO THE DUODENOSCOPE. THE AMPULLA WAS CANNULATED AS USUAL, BUT WHEN THE ERBE CHORD WAS ATTACHED AND ENERGY APPLIED, THE DEVICE DID NOT CUT AS EXPECTED. IT WAS OBSERVED UNDER ENDOSCOPIC VIEW THAT THE CUTTING WIRE WAS BROKEN. IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO CUT A NARROW DUCT, AND NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER AUTOTOME PRO RX 39 CANNULATING SPHINCTEROTOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20249675 ↗