TRUEtome 44Recalls & reported problems across all models

We found 2 models of TRUEtome 44 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 352 adverse event reports in the FDA's MAUDE database, received between Mar 3, 2017 and Sep 16, 2026 — classified as 3 injuries, 349 malfunctions.

The most frequently reported specific device problem is “Break” (262 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 44 problems

TRUEtome 44 models

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

• TRUEtome 44 M00584170

  Unit, electrosurgical, endoscopic (with or without accessories)
  237 reports
• TRUEtome 44 M00584180

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

Recent TRUEtome 44 adverse event reports

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

• MalfunctionSep 16, 2026Break; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793776 ↗
• MalfunctionSep 15, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779521 ↗
• MalfunctionSep 14, 2026Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50763510 ↗
• MalfunctionSep 14, 2026Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50763509 ↗
• MalfunctionSep 14, 2026Break; Use of Device Problem

  It was reported to Boston Scientific Corporation that a TRUEtome 44 was attempted to be used in the Papilla during an Endoscopic Retrograde Cholangiopancreatography procedure to treat Stones performed on (b)(6)2026.During the procedure, the cutting wire broke when performing sphincterotomy and the wire was lodged in the tissue. It was reported that a part of the cutting wire detached and fell into the patient and was eventually retrieved by pulling on the tome. 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.Note: The Instructions For Use (IFU) indicates that the sphincterotome does not need to be energized prior to performing sphincterotomy. Energizing the cutting wire prior to use will cause premature cutting wire fatigue and will compromise the cutting wire's integrity. However, the customer reported that the device was energized prior to bowing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754099 ↗
• MalfunctionSep 10, 2026Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50720825 ↗
• MalfunctionAug 31, 2026Break

  It was reported to Boston Scientific Corporation that a TRUEtome 44 was attempted to be used in the bile duct during an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure for a Duodenal papillotomy performed on (b)(6) 2026. During the procedure the cutting wire was fractured, and it could not be used. 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 was 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 50533777 ↗
• MalfunctionAug 13, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50244682 ↗
• MalfunctionAug 13, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50243521 ↗
• MalfunctionJul 10, 2026Break; Failure to Conduct; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 44 WAS ATTEMPTED TO BE USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CHOLANGITIS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN INSTRUCTED HER ASSISTANT TO TIGHTEN THE DEVICE TO FACILITATE FURTHER INCISION. AFTER PRESSING ON THE CAUTERY, NO CURRENT WAS GENERATED. PRIOR TO CONTINUING THE PROCEDURE, THE PHYSICIAN INSPECTED THE DEVICE AND OBSERVED THAT THE METAL TIP OF THE SPHINCTEROTOME WAS FRACTURED. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE CUTTING WIRE WAS BROKEN AND KINKED. 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 OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25788844 ↗
• MalfunctionJun 25, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TURETOME 44 WAS ATTEMPTED TO BE USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT COMMON BILE DUCT STONE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUTTING WIRE WAS FRACTURED. 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 25622813 ↗
• MalfunctionJun 10, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 44 WAS CHECKED IN THE STOCKROOM. THE EXACT EVENT DATE WAS UNKNOWN. DURING THE INVENTORY, A FOREIGN OBJECT WAS FOUND IN THE PACKAGING. SPECIFICALLY, A HAIR WAS OBSERVED WITHIN THE STERILE POUCH, VISIBLE ON THE WHITE SECTION OF THE PACKAGING ON THE RIGHT SIDE. NO PATIENT AND PROCEDURE WERE INVOLVED IN THIS EVENT. NOTE: PHOTOS OF THE COMPLAINT DEVICE INSIDE THE UNOPENED PACKAGING WERE PROVIDED BY THE CUSTOMER AND SHOWS A HAIR-LIKE PARTICLE INSIDE THE STERILE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25452705 ↗
• MalfunctionMay 25, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 44 WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT COMMON BILE DUCT STONE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUTTING WIRE WAS FRACTURED AND COULD NOT BE USED. 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 DUE TO 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 25271742 ↗
• MalfunctionMay 19, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 44 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE WIRE HAD BROKEN AT THE MIDPOINT. AS THE DEVICE WAS CAREFULLY WITHDRAWN FROM THE SCOPE, A PORTION OF THE WIRE WAS SEEN PROTRUDING. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE CUSTOMER ALSO PROVIDED A VIDEO FROM THE PROCEDURE SHOWING THE DEVICE INSIDE THE PATIENT THAT THE CUTTING WIRE BROKE. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25222688 ↗
• MalfunctionApr 20, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 44 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUTTING WIRE OF THE TRUETOME 44 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 24927597 ↗

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