TRUEtome 49 M00584160Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729827627), received between Jun 26, 2019 and Jan 5, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Break

  THIS REPORT PERTAINS TO ONE OF TWO TRUETOME 49 USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 49 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT A STRICTURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHILE USING THE SPHINCTEROTOME, THE CUTTING WIRE BREAKS SUDDENLY, THEY SWITCHED TO ANOTHER DEVICE WITH THE SAME MODEL, BUT THE SAME PROBLEM OCCURRED. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A THIRD TRUETOME 49. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959991 ↗
• MalfunctionJan 5, 2026Break

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO TRUETOME 49 USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 49 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT A STRICTURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHILE USING THE SPHINCTEROTOME, THE CUTTING WIRE BREAKS SUDDENLY, THEY SWITCHED TO ANOTHER DEVICE WITH THE SAME MODEL, BUT THE SAME PROBLEM OCCURRED. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A THIRD TRUETOME 49. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959987 ↗
• MalfunctionNov 13, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 49 WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE SPHINCTEROTOMY PROCEDURE, THE CUTTING WIRE OF THE TRUETOME 49 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 18122710 ↗
• MalfunctionDec 27, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 49 WAS USED IN THE PAPILLA MAJOR DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE HANDLE WAS PULLED TO BEND THE DEVICE. WHILE CUTTING, "THE WIRE RUPTURED AT THE DISTAL END." IT WAS REPORTED THAT THE WIRE DID NOT TOUCH THE DUODENOSCOPE AND 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 16056761 ↗
• MalfunctionMar 9, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 49 WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. THE DEVICE WAS TESTED BY BOWING IT PRIOR TO THE PROCEDURE WITH NO PROBLEMS NOTED. DURING THE PROCEDURE, WHEN THE PHYSICIAN BOWED AND ENERGIZED THE DEVICE TO CUT, "THE METAL PIECE POPPED OUT OF ONE SIDE OF THE DEVICE." IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE DEVICE OUTSIDE THE PATIENT WAS PROVIDED BY THE CUSTOMER SHOWING THE CUTTING WIRE BROKEN AND BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13713146 ↗
• MalfunctionAug 17, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A TRUETOME 49 WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE PHYSICIAN PRESSED THE FOOT SWITCH TO PERFORM SPHINCTEROTOMY, IT WAS NOTICED THAT THE PATIENT'S MUSCLE WAS TWITCHING AND THE CUTTING WIRE OF THE TRUETOME 49 BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. ADDITIONALLY, THERE WAS NO TREATMENT OR INTERVENTION PERFORMED TO ADDRESS THE PATIENT'S MUSCLE TWITCHING. THE PHYSICIAN REMOVED THE DEVICE AND THE PROCEDURE WAS COMPLETED WITH A NON BSC 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. NOTE: A PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WAS PROVIDED BY THE CUSTOMER AND SHOWED THE WIRE WAS BROKEN AND KINKED.

  Patient problems: Twitching

  MAUDE report 12332334 ↗
• MalfunctionJan 25, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 49 WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A JAGWIRE GUIDEWIRE WAS PRELOADED WITH THE TRUETOME 49 THROUGH THE DUODENOSCOPE. WHEN THE PHYSICIAN USED THE TRUETOME 49 WITH ELECTROCAUTERY, THE CUTTING WIRE BROKE. NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. REPORTEDLY, THE DEVICE WAS NOT ENERGIZED PRIOR TO BOWING AND WHEN NOT IN CONTACT WITH THE TISSUE. ALSO, THE EXPOSED CUTTING WIRE HAD FULLY EXITED THE ENDOSCOPE WHEN THE DEVICE WAS ENERGIZED. IT WAS CONFIRMED THAT THERE WAS NO DEVICE DEFICIENCY WITH THE JAGWIRE GUIDEWIRE DURING USE AND IT WAS THE SAME ORIGINAL JAGWIRE GUIDEWIRE USED TO COMPLETE THE PROCEDURE TOGETHER WITH A SECOND TRUETOME 49. 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; No Consequences Or Impact To Patient

  MAUDE report 11226388 ↗
• MalfunctionNov 3, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 49 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TOME WAS BOWED AND USED TO CUT BRIEFLY BEFORE THE CUTTING WIRE BROKE. 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 Consequences Or Impact To Patient

  MAUDE report 10780168 ↗
• MalfunctionOct 1, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 49 WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN REPOSITIONED THE BOW, THE CUTTING WIRE BROKE. REPORTEDLY, NO PART OF THE DEVICE WAS DETACHED INSIDE THE PATIENT AND THE TOME WAS REMOVED INTACT. 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 Consequences Or Impact To Patient

  MAUDE report 10613065 ↗
• MalfunctionOct 1, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 49 WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN REPOSITIONED THE BOW, THE CUTTING WIRE BROKE. REPORTEDLY, NO PART OF THE DEVICE WAS DETACHED INSIDE THE PATIENT AND THE TOME WAS REMOVED INTACT. 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 Consequences Or Impact To Patient

  MAUDE report 10612792 ↗
• MalfunctionAug 10, 2020Break; Break

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO TRUETOME 49 DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 49 WAS USED IN THE CANNULATION OF AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUTTING WIRE BROKE. A SECOND TRUETOME WAS USED; HOWEVER, THE CUTTING WIRE WAS ALSO BROKE. REPORTEDLY, NO PART OF THE DEVICE WAS DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT TOME. 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 Consequences Or Impact To Patient

  MAUDE report 10385895 ↗
• MalfunctionAug 10, 2020Break; Break

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO TRUETOME 49 DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 49 WAS USED IN THE CANNULATION OF AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUTTING WIRE BROKE. A SECOND TRUETOME WAS USED; HOWEVER, THE CUTTING WIRE WAS ALSO BROKE. REPORTEDLY, NO PART OF THE DEVICE WAS DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT TOME. 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 Consequences Or Impact To Patient

  MAUDE report 10385818 ↗
• MalfunctionJun 26, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 49 WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, IT WAS NOTICED THAT THE CUTTING WIRE BROKE WHEN THEY BOWED THE TOME. REPORTEDLY, NO PART OF THE DEVICE WAS DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SECOND TRUEOME 49, USING THE SAME GENERATOR AND ACTIVE CORD. 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 GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8735723 ↗