TRUEtome 39 M00584120Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729827771), received between May 13, 2021 and Feb 2, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Failure to Align; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED A TRUETOME 39 WHICH WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS OF WIRE FAILURE TO RELEASE BOW AND WIRE KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234746 ↗
• MalfunctionMar 12, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 39 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE BROKE WHEN THE NURSE TRIED TO PULL THE HANDLE TO RETRACT THE CUT WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRUETOME 39. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21587942 ↗
• MalfunctionNov 13, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 39 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE DEVICE WAS ROTATED TO GAIN ACCESS TO THE BILE DUCT. THE TOME DID NOT ROTATE BACK TO NEUTRAL, AND 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 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 20679468 ↗
• MalfunctionMar 12, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 39 WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, AFTER THE DEVICE WAS ACTIVATED TO PERFORM A SECOND CUT, THE CUTTING WIRE OF THE TRUETOME 39 BROKE. 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 AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18884162 ↗
• MalfunctionJan 30, 2024Break; Material Deformation; Material Integrity Problem; Break; Material Deformation; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 39 WAS USED IN THE PAPILLA AND COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHILE CUTTING WAS PERFORMED, THE CUTTING WIRE BROKE OF THE TRUETOME 39 BROKE. 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 AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: PHOTOS OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WERE PROVIDED BY THE CUSTOMER AND SHOWED THE CUTTING WIRE WAS BROKEN AND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18604183 ↗
• MalfunctionJun 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 39 WAS USED IN THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, AFTER CUTTING, IT WAS NOTICED THAT THE WIRE ANCHOR OF THE TRUETOME 39 WAS DISLODGED FROM THE CATHETER. IT WAS REPORTED THAT NO PART OF THE DEVICE WAS 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 17199731 ↗
• MalfunctionJun 21, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 39 WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE CUTTING WIRE OF THE TRUETOME 39 BROKE WHILE CUTTING. 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. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14758011 ↗
• MalfunctionJan 12, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 39 WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC PAPILLA INCISION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO ENERGIZE THE DEVICE WITHOUT ANY PROBLEM. HOWEVER, TOWARDS THE END OF THE PROCEDURE WHEN THEY TRIED TO ENERGIZE AND MAKE A LITTLE INCISION, THE CUTTING WIRE OF THE TRUETOME 39 BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS 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 13237575 ↗
• MalfunctionMay 13, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 39 WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC SPHINCTEROTOMY PROCEDURE PERFORMED ON APRIL 28, 2021. DURING THE PROCEDURE, WHEN CURRENT WAS APPLIED THROUGH THE CUTTING WIRE, AFTER ABOUT FIVE SECONDS, THE CUTTING WIRE OF THE TRUETOME 39 BROKE. 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. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816313 ↗