StonetomeRecalls & reported problems across all models

We found 5 models of Stonetome by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 160 adverse event reports in the FDA's MAUDE database, received between Feb 20, 2018 and Sep 28, 2026 — classified as 4 injuries, 156 malfunctions.

The most frequently reported specific device problem is “Break” (109 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Stonetome problems

Stonetome models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Stonetome M00535110

  DISLODGER, STONE, BILIARY
  74 reports
• Stonetome M00535150

  DISLODGER, STONE, BILIARY
  67 reports
• Stonetome M00535130

  DISLODGER, STONE, BILIARY
  10 reports
• Stonetome M00535190

  DISLODGER, STONE, BILIARY
  5 reports
• Stonetome M00535170

  DISLODGER, STONE, BILIARY
  4 reports

Recent Stonetome adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923042 ↗
• MalfunctionSep 27, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50909460 ↗
• MalfunctionJun 25, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE TO TREAT COMMON BILE DUCT STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN THE BLADE EMERGED FROM THE END OF THE SCOPE, IT WAS FACING 1, 2 O CLOCK, MAKING PAPILLOTOMY DIFFICULT. 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 RESULTS: THE CUTTING WIRE KINKED. PLEASE REFER TO BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25622842 ↗
• MalfunctionJun 17, 2026Deformation Due to Compressive Stress; 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 MAJOR DUODENAL PAPILLA (PAPILLA OF VATER) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, A SAFE PAPILLOTOMY COULD NOT BE PERFORMED DUE TO UNFAVORABLE BLADE ORIENTATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: THE CUTTING WIRE KINKED. PLEASE REFER TO BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25536442 ↗
• MalfunctionJun 16, 2026Deformation Due to Compressive Stress; 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 PAPILLA DURING A COMMON BILE DUCT (CBD) STONE REMOVAL SURGERY PROCEDURE TO TREAT CBD STONES PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT THE BLADE 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 25520909 ↗
• MalfunctionJun 8, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN THE STONETOME WAS INSERTED INTO THE ENDOSCOPE FORCEPS CHANNEL AND USED, THE CUTTING WIRE APPEARED TO BE ORIENTED IN THE OPPOSITE DIRECTION THAN USUAL. 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 RESULTS: THE CUTTING WIRE KINKED. PLEASE REFER TO BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25435616 ↗
• MalfunctionJun 1, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUTTING WIRE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 25353412 ↗
• MalfunctionApr 13, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR BILE DUCT STONES REMOVAL PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, CUTTING WIRE BROKE DURING A PAPILLA INCISION. 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 24858747 ↗
• MalfunctionMar 16, 2026Break; Deformation Due to Compressive Stress; 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 AN UNKNOWN DATE. DURING THE PROCEDURE, BLADE DIRECTION WAS ABNORMAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF DEVICE CUTTING WIRE BROKEN AND KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24606909 ↗
• MalfunctionJan 29, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE TO TREAT CHOLEDOCHOLITHIASIS PERFORMED ON (B)(6) 2026. DURING THE PREPARATION OUTSIDE THE PATIENT, THE BLADE OF THE CUTTING WIRE WAS FOUND TO BE DEFORMED WHEN UNPACKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 24206886 ↗
• MalfunctionJan 20, 2026Deformation Due to Compressive Stress; 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 PAPILLA OF VATER DURING A PAPILLOTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, CUTTING WIRE WAS NOT ORIENTED AS USUAL AND WAS NOT POINTING TOWARDS THE 11 O'CLOCK POSITION AT ALL. 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 WIRE KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24127172 ↗
• MalfunctionJan 15, 2026Break; Deformation Due to Compressive Stress; 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 PAPILLA OF VATER DURING A PAPILLOTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BLADE ORIENTATION WAS EXTREMELY POOR, ALTHOUGH THE TARGET WAS THE 11 O'CLOCK DIRECTION, IT REMAINED POINTED AT 3 O'CLOCK AND DID NOT CHANGE DIRECTION. 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 WIRE BREAK AND WIRE KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24078809 ↗
• MalfunctionJan 14, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE ATTEMPTING TO USE THE STONETOME, AN ABNORMALITY WAS OBSERVED IN THE DIRECTION OF THE CUTTING WIRE. 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 DEVICE CUTTING WIRE KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24075991 ↗
• MalfunctionJan 9, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STONETOME DEVICE WAS INSERTED INTO THE FORCEPS CHANNEL. WHEN THE CUTTING WIRE WAS PULLED AND OPERATED, THE BLADE APPEARED ORIENTED TOWARD THE 1 O CLOCK POSITION INSTEAD OF THE EXPECTED NEUTRAL ALIGNMENT. 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 DEVICE CUTTING WIRE KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24025549 ↗
• MalfunctionJan 6, 2026Break; 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 CUTTING WIRE GOT BROKEN DURING PAPILLOTOMY. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONETOME. 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 23985997 ↗

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