Dreamtome RX 49Recalls & reported problems across all models

We found 4 models of Dreamtome RX 49 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 19 adverse event reports in the FDA's MAUDE database, received between Oct 16, 2018 and Mar 6, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Break” (19 reports).

4 FDA recall records name at least one of these models by its device identifier, 4 still open.

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

Dreamtome RX 49 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 22, 2021Open, Classified

   Sterility of device is compromised due to a sterile barrier breach

   Z-0758-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

2. Dec 22, 2021Open, Classified

   Sterility of device is compromised due to a sterile barrier breach

   Z-0757-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

3. Dec 22, 2021Open, Classified

   Sterility of device is compromised due to a sterile barrier breach

   Z-0756-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

4. Dec 22, 2021Open, Classified

   Sterility of device is compromised due to a sterile barrier breach

   Z-0755-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported Dreamtome RX 49 problems

Dreamtome RX 49 models

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

• Dreamtome™ RX 49 M00584000

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall8 reports
• Dreamtome™ RX 49 M00584010

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall8 reports
• Dreamtome™ RX 49 M00584030

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall3 reports
• Dreamtome™ RX 49 M00584020

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall0 reports

Recent Dreamtome RX 49 adverse event reports

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

• MalfunctionMar 6, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 49 WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE STAFF WENT TO USE DREAMTOME RX 49 AND THEN JUST BROKE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533627 ↗
• InjuryFeb 15, 2026Break; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 49 WAS USED IN THE BILE DUCT DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, BREAKAGE OF THE SPHINCTEROTOME OCCURRED DURING A DIFFICULT MANEUVER WHERE THE SPHINCTEROTOME WAS SLIGHTLY FORCED. RELEASE OF THE MAIN BILE DUCT ACHIEVED AFTER EXTRACTION OF A 2 CENTIMETERS STONE. THE DEVICE WAS RETRIEVED IN ITS ENTIRETY. IT WAS REPORTED THAT THE PATIENT WAS BEING RE-HOSPITALIZED FOR MODERATELY SEVERE POST-CATHETERIZATION PANCREATITIS AND PAIN.

  Patient problems: Pain; Pancreatitis

  MAUDE report 24341505 ↗
• MalfunctionJan 9, 2026Break; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 49 WAS ATTEMPTED TO BE USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUTTING WIRE OF THE DEVICE BROKE IN THE MIDDLE. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED 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 DREAMTOME RX 49. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24026654 ↗
• MalfunctionJan 5, 2026Break; Adverse Event Without Identified Device or Use Problem

  THIS REPORT PERTAINS TO ONE OF TWO DREAMTOME RX 49 USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 49 WAS ATTEMPTED TO BE USED DURING A SPHINCTEROTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE BROKE INTO TWO. THE SAME PROBLEM OCCURRED WITH THE SECOND DREAMTOME RX 49. THE PROCEDURE WAS COMPLETED WITH A THIRD MEDICAL DEVICE FROM A DIFFERENT REFERENCE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23962242 ↗
• MalfunctionJan 5, 2026Break; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DREAMTOME RX 49 USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 49 WAS ATTEMPTED TO BE USED DURING A SPHINCTEROTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE BROKE INTO TWO. THE SAME PROBLEM OCCURRED WITH THE SECOND DREAMTOME RX 49. THE PROCEDURE WAS COMPLETED WITH A THIRD MEDICAL DEVICE FROM A DIFFERENT REFERENCE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23962166 ↗
• MalfunctionMay 14, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 49 WAS ATTEMPTED TO BE USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE BROKE. IT WAS REPORTED THAT ONE SIDE OF THE CUTTING WIRE BROKE OFF AND NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DREAMTOME RX 49. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22016759 ↗
• MalfunctionNov 13, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 49 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE DEVICE WAS ADVANCED THROUGH THE SCOPE AND WHEN THE PHYSICIAN REQUESTED TO BOW IT, THE CUTTING WIRE OF THE DREAMTOME RX 49 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. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678774 ↗
• MalfunctionNov 13, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 49 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2024. DURING THE PROCEDURE, THE DEVICE WAS ADVANCED THROUGH THE SCOPE AND WHEN THE PHYSICIAN REQUESTED TO BOW IT, THE CUTTING WIRE OF THE DREAMTOME RX 49 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. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678633 ↗
• MalfunctionFeb 9, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 49 WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE GUIDEWIRE WAS ADVANCED IN PLACE, AND THE SPHINCTEROTOMY WAS PERFORMED. DURING THE SPHINCTEROTOMY, THE CUTTING WIRE OF THE DREAMTOME RX 49 BROKE AT THE PROXIMAL PART. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 BROKEN AND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16341372 ↗
• MalfunctionAug 24, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 49 WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE CUTTING WIRE OF THE DREAMTOME RX 49 BROKE WHICH WAS IMPOSSIBLE FOR THEM TO PERFORM SPHINCTEROTOMY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS 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 12362596 ↗
• MalfunctionMay 5, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 49 WAS USED IN THE MAIN BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE CUTTING WIRE BROKE WHEN THE DEVICE WAS BOWED. IT WAS REPORTED THAT THE CUTTING WIRE WAS PARTIALLY DETACHED FROM THE SPHINCTEROTOME; HOWEVER, NO PART 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 11776227 ↗
• MalfunctionNov 12, 2020Break; Break

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DREAMTOME RX 49 DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 49 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUTTING WIRE BROKE. A SECOND DREAMTOME RX 49 WAS USED; HOWEVER, THE SAME ISSUE OCCURED. REPORTEDLY, NO PART OF THE DEVICE WAS DETACHED INSIDE 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 Consequences Or Impact To Patient

  MAUDE report 10833209 ↗
• MalfunctionNov 12, 2020Break; Break

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO DREAMTOME RX 49 DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 49 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUTTING WIRE BROKE. A SECOND DREAMTOME RX 49 WAS USED; HOWEVER, THE SAME ISSUE OCCURED. REPORTEDLY, NO PART OF THE DEVICE WAS DETACHED INSIDE 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 Consequences Or Impact To Patient

  MAUDE report 10833172 ↗
• MalfunctionAug 4, 2020Break; Break

  IT WAS REPORTED TO BOSON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 49 WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUTTING WIRE BROKE WHEN THEY USED THE ELECTRIC MONOPOLAR GENERATOR. REPORTEDLY, NO PART OF THE DEVICE WAS DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED ANOTHER FO THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10361159 ↗
• MalfunctionJun 4, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 DEVICE WAS USED DURING A PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE SCALPEL CUT WAS STARTED, THE SPHINCTEROTOME STRETCHED AND IT BROKE BEFORE BEING ABLE TO USE THE SCALPEL. THE PROCEDURE WAS COMPLETED WITH ANOTHER DREAMTOME RX 44 DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10121527 ↗

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