TRUEtome Dreamwire 44 M00583210Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729858751), received between Jul 3, 2018 and Mar 23, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME DREAMWIRE 44 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE SPHINCTEROTOME WIRE SNAPPED WHILE PERFORMING A SPHINCTEROTOMY. THE WIRE WAS REMOVED FROM SCOPE EASILY. IT WAS REPORTED THAT THE DEVICE BROKE INSIDE THE PATIENT DESPITE BEING USED CORRECTLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24665093 ↗
• MalfunctionNov 26, 2025Peeled/Delaminated; Material Deformation; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME DREAMWIRE 44 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PREPARATION, IT WAS NOTICED THAT THE GUIDE WIRE WAS FRAYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF CUTTING WIRE KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23660386 ↗
• MalfunctionDec 7, 2022Break; Detachment of Device or Device Component; Material Deformation; Break; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME DREAMWIRE 44 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 DREAMWIRE 44 BROKE. IT WAS ALSO REPORTED THAT THE HYDROPHILIC TIP OF THE PRELOADED GUIDEWIRE WAS DETACHED AND WAS RETRIEVED SUCCESSFULLY. THE DETACHED HYDROPHILIC TIP OF THE PRELOADED GUIDEWIRE IS BIOCOMPATIBLE AND CAN BE PASSED NATURALLY BY THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WAS PROVIDED BY THE CUSTOMER AND SHOWED THE CUTTING WIRE WAS BROKEN AND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15929840 ↗
• MalfunctionMay 5, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME DREAMWIRE 44 WAS USED IN THE PAPILLA OF VATER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE CUTTING WIRE OF THE TRUETOME DREAMWIRE 44 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14291342 ↗
• MalfunctionDec 5, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME DREAMWIRE 44 WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE PHYSICIAN WANTED TO PERFORM SPHINCTEROTOMY TO CUT THE PAPILLA, WHEN HE PRESSED THE PEDAL TO DELIVER CURRENT TO THE DEVICE, THE CUTTING WIRE OF THE TRUETOME DREAMWIRE 44 BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE DEVICE WAS REMOVED AND 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 12931387 ↗
• InjuryJul 3, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME¿ DREAMWIRE¿ 44 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUTTING WIRE BROKE AND DETACHED INSIDE THE PATIENT. THE DETACHED PIECE OF THE CUTTING WIRE WAS RETRIEVED FROM THE PATIENT AND IT IS UNKNOWN WHAT DEVICE WAS USED TO RETRIEVE THE DETACHED PART. THE PROCEDURE WAS COMPLETED WITH A 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 7660496 ↗