Stonetome M00535130Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729146575), received between Jun 17, 2021 and Dec 24, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2025Burst Container or Vessel; Material Deformation; Adverse Event Without Identified Device or Use Problem; Burst Container or Vessel; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON RUPTURED IMMEDIATELY UPON INITIAL USE OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF CUTTING WIRE KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888890 ↗
• MalfunctionAug 15, 2025Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE DEVICE WAS BOWED, THE ORIENTATION OF THE CUTTING WIRE WAS DIFFERENT FROM USUAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT AFTER THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF CUTTING WIRE KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22813110 ↗
• MalfunctionAug 5, 2025Material Deformation; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Material Deformation; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE TIP OF THE KNIFE WAS ORIENTED DIFFERENTLY THAN INTENDED. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED BY THE COMPLAINANT WHERE IT CAN BE OBSERVED THAT THE WORKING LENGTH WAS KINKED AND TWISTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONETOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF A CUTTING WIRE KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720841 ↗
• InjuryJun 20, 2025Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS ATTEMPTED TO BE USED IN THE PAPILLA DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN AN INCISION IN THE PAPILLA WAS MADE, IT RESULTED IN BLEEDING, AND IT WAS DIFFICULT TO STOP THE BLEEDING. WHEN THE DEVICE WAS REMOVED FROM THE FORCEPS OPENING, THE BLADE WAS BENT. A METALLIC STENT WAS PLACED FOR HEMOSTASIS TO STOP THE BLEEDING AND COMPLETED THE PROCEDURE. NO FURTHER INFORMATION WAS RECEIVED DESPITE GOOD FAITH EFFORTS. NOTE: A PHOTO OF THE DEVICE WAS PROVIDED BY THE COMPLAINANT AND SHOWED THAT THE CUTTING WIRE WAS KINKED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22301732 ↗
• MalfunctionFeb 19, 2025Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED DURING AN ENDOSCOPIC STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE KNIFE WAS OPERATED USING THE PROXIMAL HANDLE, BUT THE TIP OF THE KNIFE DID NOT MOVE, SO IT WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A SECOND STONETOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: WIRE BROKEN. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21417337 ↗
• MalfunctionJun 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC PAPILLOTOMY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE OUTSIDE THE PATIENT, WHEN THE MANDREL WAS ATTEMPTED TO BE REMOVED FROM THE STONETOME, ONLY THE TIP CAME OFF AND THE SHEATH COULD NOT BE REMOVED. 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 17164813 ↗
• MalfunctionNov 22, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, ENDOSCOPIC SPHINCTEROTOMY (EST) WAS PERFORMED, AND THE COMMON BILE DUCT STONES WERE REMOVED SEVERAL TIMES USING THE BALLOON OF THE STONETOME. SINCE ADDITIONAL EST WAS NECESSARY, AN INCISION WAS TRIED USING THE STONETOME. HOWEVER, IT WAS NOTICED THAT THE CUTTING WIRE SEPARATED FROM THE PROXIMAL SIDE HANGING FREELY WHICH WAS VISIBLE ON THE MONITOR. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE DEVICE WAS REMOVED SLOWLY TO AVOID THE RISK OF PUNCTURING THE DUODENUM. UPON CHECK THE DEVICE, IT WAS FOUND THAT THE CUTTING WIRE WAS ALSO KINKED. THE PROCEDURE WAS COMPLETED WITH A NON BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15843122 ↗
• MalfunctionSep 7, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE DUODENAL PAPILLA OF VATER DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE CUTTING WIRE WAS SEPARATED IN THE MIDDLE OF THE PROCESS. 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 15374329 ↗
• MalfunctionDec 22, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE COMMON BILE DUCT DURING A BILIARY STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE CUTTING WIRE OF THE STONETOME BROKE DURING THE INCISION OF THE PAPILLA. IT WAS REPORTED THAT THE CUTTING WIRE BROKE WHEN THE DEVICE WAS ENERGIZED. ADDITIONALLY, NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13065534 ↗
• MalfunctionJun 17, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE COMMON BILE DUCT DURING A BILIARY STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN ENDOSCOPIC SPHINCTEROTOMY (EST) WAS ABOUT TO BE PERFORMED, THE CUTTING WIRE OF THE STONETOME BROKE. NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. IT WAS REPORTED THAT THERE WAS NO PROBLEM NOTED WHEN THE DEVICE WAS FUNCTIONALLY CHECKED DURING PREPARATION. THE DEVICE WAS REMOVED AND A LEAK TEST OF THE SCOPE WAS PERFORMED. SINCE THERE WAS NO PROBLEM FOUND, THE PROCEDURE WAS CONTINUED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WAS PROVIDED BY THE CUSTOMER AND SHOWS THE CUTTING WIRE BROKEN AND KINKED/BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12020919 ↗