TRUEtome Hydra 44 M00583170Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729858713), received between Jan 21, 2020 and Feb 27, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME HYDRA 44 WAS USED IN THE PAPILLA OF VATER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE WAS INSERTED, AND THE WIRE WAS TIGHTENED AS ORDERED BY THE PHYSICIAN. THE DEVICE WAS THEN CONNECTED TO THE DIATHERMY MACHINE AND AT FIRST APPLICATION OF CURRENT THE CUTTING WIRE OF THE TRUETOME HYDRA 44 ON THE PROXIMAL SIDE BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRUETOME UTILIZING THE HYDRA GUIDEWIRE FROM THE FIRST SPHINCTEROTOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. 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 21479606 ↗
• MalfunctionFeb 5, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME HYDRA 44 WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE TRUETOME HYDRA 44 WAS INSERTED THROUGH THE PAPILLA AND INTO THE BILIARY TRACT BY THE PHYSICIAN AND CONTRAST WAS ADMINISTERED. THE DEVICE WAS CONNECTED TO THE GENERATOR AND THE CUTTING WIRE WAS TENSIONED. WHEN THE FIRST CURRENT WAS APPLIED, THE PROXIMAL PART OF THE CUTTING WIRE BROKE. IT WAS THEN REMOVED AND REPLACED WITH ANOTHER OF THE SAME DEVICE THAT COMPLETED THE PROCEDURE SUCCESSFULLY. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. A PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WERE PROVIDED BY THE CUSTOMER AND SHOWED THE CUTTING WIRE WAS BROKEN AND KINKED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21315417 ↗
• MalfunctionMar 1, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME HYDRA 44 WAS USED IN THE PAPILLA OF VATER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE PHYSICIAN STARTED TO PERFORM SPHINCTEROTOMY, THE CUTTING WIRE BROKE. REPORTEDLY, NO PART OF THE DEVICE WAS DETACHED AND FELL INTO THE PATIENT. ADDITIONALLY, THE DEVICE WAS ENERGIZED PRIOR TO BOWING AND IN CONTACT WITH THE TISSUE. ALSO, THE EXPOSED CUTTING WIRE HAD FULLY EXITED THE ENDOSCOPE WHEN THE DEVICE WAS ENERGIZED. 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 11392375 ↗
• MalfunctionJan 21, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME HYDRA 44 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE SPHINCTEROTOME WAS TENSED, THE CUTTING WIRE BROKE. REPORTEDLY, NO PART OF THE DEVICE WAS DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH DIFFERENT 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 Consequences Or Impact To Patient

  MAUDE report 9610219 ↗