TRUEtome Dreamwire 44Recalls & reported problems across all models
Boston Scientific Corporation · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 2 models of TRUEtome Dreamwire 44 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Jul 3, 2018 and Mar 23, 2026 — classified as 1 injury, 24 malfunctions.
The most frequently reported specific device problem is “Break” (24 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
Reports received per month, all models
Most reported TRUEtome Dreamwire 44 problems
Device problems
- Break24
- Material Deformation3
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Peeled/Delaminated1
- Use of Device Problem1
Patient problems
- No Consequences Or Impact To Patient14
- No Clinical Signs, Symptoms or Conditions11
TRUEtome Dreamwire 44 models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TRUEtome Dreamwire 44 M00583190Unit, electrosurgical, endoscopic (with or without accessories)19 reports
- TRUEtome Dreamwire 44 M00583210Unit, electrosurgical, endoscopic (with or without accessories)6 reports
Recent TRUEtome Dreamwire 44 adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionDec 3, 2025Break; 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 TO TREAT STONES PERFORMED ON (B)(6) 2025. DURING PROCEDURE, AT THE MOMENT OF THE PASSAGE OF ELECTRIC CURRENT FOR THE OPENING OF THE PAPILLA THE CUTTING BLADE 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 23708881 ↗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 ↗MalfunctionJul 15, 2025Break; Use of Device Problem; Material Deformation; Break; Use of Device Problem; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME DREAMWIRE 44 WAS ATTEMPTED TO BE USED IN THE PAPILLA OF VATER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR THE TREATMENT OF STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, 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 TRUETOME DREAMWIRE 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THE COMPLAINANT REPORTED THAT THE DEVICE WAS ENERGIZED PRIOR TO BOWING. HOWEVER, ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), PRECAUTION: 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. ADDITIONALLY, A PHOTO OF THE COMPLAINT DEVICE INSIDE THE PACKAGING WAS PROVIDED BY THE CUSTOMER AND SHOWED THE CUTTING WIRE WAS BROKEN AND KINKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22515589 ↗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 ↗MalfunctionAug 5, 2021Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME DREAMWIRE 44 WAS USED NEAR THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THEY WERE CUTTING THE PAPILLA, 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 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 12280451 ↗MalfunctionJul 27, 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 PROCEDURE, AS THEY WERE APPROACHING CLOSER TO THE PAPILLA, THE CUTTING WIRE OF THE TRUETOME DREAMWIRE 44 BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12228946 ↗MalfunctionJul 27, 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 PROCEDURE, AS THEY WERE APPROACHING CLOSER TO THE PAPILLA, THE CUTTING WIRE OF THE TRUETOME DREAMWIRE 44 BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12228660 ↗MalfunctionJul 27, 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 PROCEDURE, AS THEY WERE APPROACHING CLOSER TO THE PAPILLA, THE CUTTING WIRE OF THE TRUETOME DREAMWIRE 44 BROKE. THERE WAS NO INFORMATION ON HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12228590 ↗MalfunctionMar 2, 2020Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME DREAMWIRE 44 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUTTING WIRE BROKE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9777492 ↗MalfunctionMar 2, 2020Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME DREAMWIRE 44 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUTTING WIRE BROKE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9777485 ↗MalfunctionMar 2, 2020Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME DREAMWIRE 44 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUTTING WIRE BROKE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9777470 ↗MalfunctionFeb 28, 2020Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME DREAMWIRE 44 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUTTING WIRE BROKE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9772196 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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