Stonetome M00535170Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729146629), received between May 17, 2021 and Jul 28, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2025Break; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Break; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE COMMON BILE DUCT DURING A LITHOTRIPSY PROCEDURE TO TREAT BILE DUCT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE WAS INSERTED INTO AN ENDOSCOPE AND PAPILLOTOMY WAS ATTEMPTED. IT WAS NOTED THAT THE CUTTING WIRE DID NOT REACH THE PAPILLA EVENLY, WHICH MADE IT UNABLE TO PERFORM INCISION PROPERLY THAT RESULTED IN LONGER TIME FOR ENERGIZATION. IT WAS REPORTED THAT THE CUTTING WIRE OF THE STONETOME GOT TORN WHEN THE HANDLE WAS FORCEFULLY GRASPED TO APPLY IT ON THE PAPILLA. 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 22639485 ↗
• MalfunctionMay 6, 2025Break; 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 STONETOME WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING STONE REMOVAL SURGERY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE PRODUCT INSERTED INTO THE COMMON BILE DUCT AND ENERGIZED, THE CUTTING WIRE BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONETOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971897 ↗
• MalfunctionJul 8, 2021Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE PAPILLA DURING A PAPILLOTOMY PROCEDURE PERFORMED ON (B)(6) 2021. DURING PROCEDURE, IT WAS NOTICED THAT THE "DIRECTION OF THE BLADE" OF THE STONETOME WAS INCORRECT. 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 12136177 ↗
• MalfunctionMay 17, 2021Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE, IT WAS NOTICED THAT THE "DIRECTION OF THE BLADE" OF THE STONETOME WAS INCORRECT. 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 11838207 ↗