TRUEtome 39Recalls & reported problems across all models

We found 2 models of TRUEtome 39 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 55 adverse event reports in the FDA's MAUDE database, received between Apr 3, 2018 and Sep 10, 2026 — classified as 55 malfunctions.

The most frequently reported specific device problem is “Break” (46 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 TRUEtome 39 problems

TRUEtome 39 models

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

• TRUEtome 39 M00584190

  Unit, electrosurgical, endoscopic (with or without accessories)
  46 reports
• TRUEtome 39 M00584120

  Unit, electrosurgical, endoscopic (with or without accessories)
  9 reports

Recent TRUEtome 39 adverse event reports

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

• MalfunctionSep 10, 2026Break; Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50723725 ↗
• MalfunctionSep 3, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50599746 ↗
• MalfunctionAug 31, 2026Break; Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50533767 ↗
• MalfunctionApr 17, 2026Failure to Conduct; Material Integrity Problem

  NOTE: THIS REPORT PERTAINS TO A JAGWIRE REVOLUTION, TRUETOME 39, TWO TRAPEZOID RX LITHOTRIPTER BASKETS, AND CRE PRO WIREGUIDED DILATATION BALLOON USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE REVOLUTION, TRUETOME 39, TWO TRAPEZOID RX LITHOTRIPTER BASKETS, AND CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND CBD STONE REMOVAL PROCEDURE TO JAUNDICE AND CBD STONE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, AFTER THE STONE WAS CAPTURED, THE BASKET COULD NOT BE PULLED THROUGH THE PAPILLA. THE TRAPEZOID RX BASKET WAS THEN CONNECTED TO AN ALLIANCE HANDLE TO PERFORM LITHOTRIPSY. DURING LITHOTRIPSY, THE BASKET FRACTURED AT THE HANDLE END, AND THE SAFETY RELEASE MECHANISM DID NOT ACTIVATE TO ALLOW RELEASE OF THE STONE FROM THE BASKET. THE PHYSICIAN THEN PERFORMED ANOTHER CRE DILATION, BUT THE CRE BALLOON DEVELOPED A SMALL RUPTURE DURING INFLATION. FOLLOWING THE RUPTURE OF THE CRE BALLOON, THE PHYSICIAN ATTEMPTED A PARTIAL PAPILLOTOMY USING A TRUETOME. HOWEVER, THE CUTTING EFFICIENCY WAS POOR, POSSIBLY DUE TO INTERFERENCE FROM A CBD STONE OR THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918055 ↗
• MalfunctionFeb 2, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 39 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT OBSTRUCTION PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN THE TOME WAS BOWED AND CAUTERY APPLIED FOR SPHINCTEROTOMY, THE WIRE BROKE. IT WAS REPORTED THAT NO PART OF THE DEVICE WAS DETACHED AND FELL INSIDE 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 WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234859 ↗
• 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 ↗
• MalfunctionJan 21, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 39 WAS ATTEMPTED TO BE USED IN THE AMPULLA/PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PROCEDURE, UPON BOWING OR STEPPING ON THE PEDAL, THE CUT WIRE BROKE OFF FROM THE TIP OF THE TOME. 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 WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24140803 ↗
• MalfunctionJan 9, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 39 WAS BEING PREPARED FOR USED IN THE PAPILLA DURING A PROCEDURE TO TREAT COMMON BILE DUCT STONE TO BE PERFORMED ON (B)(6) 2025. DURING PREPARATION, THE CUTTING WIRE WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRUETOME 39. 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 24025547 ↗
• MalfunctionDec 24, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 39 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILIARY STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN BOWING THE TOME THE CUTTING WIRE SNAPPED. 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 AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED. NOTE: IT WAS REPORTED THAT THE DEVICE WAS ENERGIZED WHEN NOT IN CONTACT WITH TISSUE; HOWEVER, PER THE INSTRUCTIONS FOR USE (IFU), PRECAUTION: IT IS RECOMMENDED TO MAINTAIN DIRECT AND CONSTANT CONTACT WITH TISSUE WHEN APPLYING ELECTROCAUTERY CURRENT. FAILURE TO DO SO MAY RESULT IN BROKEN CUT WIRE, DAMAGE TO THE ENDOSCOPE AND/OR PATIENT INJURY. ADDITIONALLY, IT WAS ALSO INDICATED THAT THE DEVICE WAS ENERGIZED PRIOR TO BOWING; HOWEVER, ACCORDING TO THE IFU, THE DEVICE DOES NOT NEED TO BE ENERGIZED PRIOR TO PERFORMING SPHINCTEROTOMY AS ENERGIZING THE CUTTING WIRE PRIOR TO USE WILL CAUSE PREMATURE CUTTING WIRE FATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888521 ↗
• MalfunctionSep 23, 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 TRUETOME 39 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT JAUNDICE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE TRUETOME WAS INSERTED INTO ENDOSCOPE, AND THE TIP WAS ALSO PARTIALLY INSERT INTO PAPILLA. WHEN THE TECHNICIAN TRIED TO USE THE HANDLE TO BEND THE TIP AND CUT PAPILLA, 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 THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23124759 ↗
• MalfunctionJul 18, 2025Entrapment of Device; Use of Device Problem; Entrapment of Device; Use of Device Problem

  NOTE: THIS REPORT PERTAINS TO ONE TRUETOME 39 AND ONE JAGWIRE DEVICE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 39 WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE WAS LOADED OVER A 0.035 JAGWIRE, AND CANNULATED SUCCESSFULLY, BUT COULD NOT BE EXCHANGED AS THE WIRE WAS STUCK IN THE DEVICE. IT WAS THEN REALIZED THAT THIS WIRE WAS NOT COMPATIBLE WITH THE TOME. BOTH TOME AND WIRE WERE REMOVED FROM PATIENT, AND A NON-BOSTON SCIENTIFIC DEVICE WERE ATTEMPTED TO BE USED, BUT UNABLE TO RECANNULATE THE BILE DUCT. THE PROCEDURE WAS NOT COMPLETED AND WAS CANCELED AFTER THE PATIENT HAD BEEN SEDATED WITH GENERAL ANESTHESIA. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THE COMPLAINANT REPORTED THAT THE DEVICE WAS LOADED OVER A 0.035 JAGWIRE. HOWEVER, ACCORDING TO THE DIRECTIONS FOR USE (DFU), THE TRUETOME 39 SPHINCTEROTOME IS CAPABLE OF ACCEPTING A 0.025 IN (0.64 MM) GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22548345 ↗
• MalfunctionJun 30, 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 TRUETOME 39 WAS ATTEMPTED TO BE USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE PHYSICIAN BOWED THE TRUETOME FOR THE FIRST TIME, THE CUTTING WIRE AT THE DISTAL TIP BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRUETOME 39. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22355828 ↗
• MalfunctionJun 25, 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 TRUETOME 39 WAS USED IN THE AMPULLA OF VATER (AOV) DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE PERFORMED ON (B)(6) 2025 DURING THE PROCEDURE, WHEN THE PHYSICIAN TRIES TO CUT THE AOV, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331167 ↗
• MalfunctionMay 5, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 39 WAS ATTEMPTED TO BE USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE DISCONNECTED. IT WAS REPORTED THAT THE CUTTING WIRE BROKE AND NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRUETOME 39. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21962016 ↗
• MalfunctionApr 30, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 39 WAS ATTEMPTED TO BE USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE WAS DISCONNECTED. 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 21936556 ↗

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