Dreamwire M00556100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729779544), received between Sep 17, 2025 and Sep 17, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2025Difficult to Advance; Difficult to Advance

  NOTE: THIS REPORT PERTAINS TO ONE OF NINE BOSTON SCIENTIFIC DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMWIRE WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) METAL STENT PLACEMENT PROCEDURE TO TREAT STENOSIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS NOT POSSIBLE TO ADVANCE THE JAGWIRE IN A JAGTOME RX. A SECOND JAGTOME RX WAS USED IN ORDER TO ADVANCE THE JAGWIRE THROUGH THE TOME WITHOUT SUCCESS. AN AUTOTOME RX WAS USED IN COMBINATION WITH A DREAMWIRE BUT ALSO THIS GUIDEWIRE COULD NOT BE ADVANCED THROUGH THE TOME. A SECOND AUTOTOME RX WAS USED IN COMBINATION WITH A DREAMWIRE BUT ALSO THIS GUIDEWIRE COULD NOT BE ADVANCED THROUGH THE TOME. AS A LAST ATTEMPT AN RX CANNULA WAS USED IN COMBINATION WITH A DREAMWIRE BUT WITHOUT RESULT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT, AND THE PATIENT WILL BE RESCHEDULED FOR A NEXT ERCP. IT WAS REPORTED THAT THE RESCHEDULED PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS TREATED SUCCESSFULLY, THE RESCHEDULED DATE WAS UNKNOWN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23080413 ↗
• MalfunctionSep 17, 2025Difficult to Advance; Difficult to Advance

  NOTE: THIS REPORT PERTAINS TO ONE OF NINE BOSTON SCIENTIFIC DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMWIRE WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) METAL STENT PLACEMENT PROCEDURE TO TREAT STENOSIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS NOT POSSIBLE TO ADVANCE THE JAGWIRE IN A JAGTOME RX. A SECOND JAGTOME RX WAS USED IN ORDER TO ADVANCE THE JAGWIRE THROUGH THE TOME WITHOUT SUCCESS. AN AUTOTOME RX WAS USED IN COMBINATION WITH A DREAMWIRE BUT ALSO THIS GUIDEWIRE COULD NOT BE ADVANCED THROUGH THE TOME. A SECOND AUTOTOME RX WAS USED IN COMBINATION WITH A DREAMWIRE BUT ALSO THIS GUIDEWIRE COULD NOT BE ADVANCED THROUGH THE TOME. AS A LAST ATTEMPT AN RX CANNULA WAS USED IN COMBINATION WITH A DREAMWIRE BUT WITHOUT RESULT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT, AND THE PATIENT WILL BE RESCHEDULED FOR A NEXT ERCP. IT WAS REPORTED THAT THE RESCHEDULED PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS TREATED SUCCESSFULLY, THE RESCHEDULED DATE WAS UNKNOWN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23074351 ↗