Dreamtome RX 44Recalls & reported problems across all models

We found 4 models of Dreamtome RX 44 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 306 adverse event reports in the FDA's MAUDE database, received between Jan 30, 2017 and Sep 17, 2026 — classified as 9 injuries, 297 malfunctions.

The most frequently reported specific device problem is “Break” (224 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 44 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-0754-2022 · 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-0753-2022 · 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-0752-2022 · 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-0751-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported Dreamtome RX 44 problems

Dreamtome RX 44 models

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

• Dreamtome™ RX 44 M00584040

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall165 reports
• Dreamtome™ RX 44 M00584050

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall127 reports
• Dreamtome™ RX 44 M00584060

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall13 reports
• Dreamtome™ RX 44 M00584070

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall1 report

Recent Dreamtome RX 44 adverse event reports

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

• MalfunctionSep 17, 2026Failure to Fold; Deformation Due to Compressive Stress

  It was reported to Boston Scientific Corporation that a Dreamtome RX 44 was attempted to be used during an Endoscopic retrograde cholangiopancreatography (ERCP) procedure to treat stones performed on (b)(6)2026. During the procedure, the tech mentioned that they were having a hard time bowing the device fully, and that the handle felt like it was sticking. After sphincterotomy was performed and the device was unbowed, it was observed that one side of the cutting wire became dislodged and was sticking out. The procedure was completed with the original device. There was 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 50803739 ↗
• InjurySep 15, 2026Break; Difficult to Remove

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Loss of consciousness

  MAUDE report 50780240 ↗
• MalfunctionSep 12, 2026Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50744706 ↗
• MalfunctionSep 11, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50744193 ↗
• MalfunctionSep 9, 2026Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50700941 ↗
• MalfunctionMay 6, 2026Break; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 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 BROKE. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THE CUTTING WIRE WAS BROKEN AND KINKED. IT WAS REPORTED THAT NO PARTS 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 25107652 ↗
• MalfunctionApr 30, 2026Failure to Align; Infusion or Flow Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STRICTURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT BEFORE INSERTION OF THE TOME INTO THE BIOPSY PORT, THE PHYSICIAN NOTICED THAT THE TIP WAS VERY BOWED. THE ASSISTANT ATTEMPTED TO UNBOW IT, BUT THE CUTTING WIRE WILL NOT RELEASE THE BOW; IT MADE CANNULATION MORE DIFFICULT. IT WAS ALSO REPORTED THERE WAS A BIT OF RESISTANCE WHEN INJECTING CONTRAST. A PHOTO WAS PROVIDED FROM THE CUSTOMER, SHOWING THAT THE CUTTING WIRE WAS IN BOWED POSITION. IT WAS REPORTED THAT THE ORIGINAL METHOD AND DEVICE WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25038797 ↗
• MalfunctionApr 17, 2026Break; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT COMMON BILE DUCT STONES PERFORMED ON (B)(6) 2026. DURING PROCEDURE, THE CUTTING WIRE BROKE WHILE BEING TENSIONED. 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 A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24906464 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT A DREAMTOME RX 44 WAS ATTEMPTED TO BE USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, A DREAMTOME CUT WIRE BROKE WHEN TRYING TO PERFORM A SPHINCTEROTOMY. IT WAS REPORTED THAT NO CUTTING WIRE WAS DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818938 ↗
• MalfunctionMar 30, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CBD STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN THE ENDOSCOPIST ATTEMPTED TO FURTHER BOW THE INSTRUMENT TO INCREASE THE CUTTING ANGLE AND EXTEND THE SPHINCTEROTOMY, THE FILAMENT WIRE SNAPPED. IT WAS REPORTED THAT THE CUTTING WIRE WAS INTACT, BUT THE WIRE ANCHOR DISLODGED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. IT WAS REPORTED THAT NO CUTTING WIRE WAS DETACHED INTO THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24731880 ↗
• MalfunctionMar 25, 2026Failure to Align

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING PROCEDURE, IT WAS REPORTED THAT DEVICE WOULD NOT UNBOW COMPLETELY AND COULD NOT BE PUSHED DOWN THE CAP OF THE LOCKING DEVICE. THE PROCEDURE WAS COMPLETED USING 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 24690853 ↗
• MalfunctionMar 11, 2026Failure to Align

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN DREAMTOME RX 44 WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PREPARATION, WAS REPORTED THAT MULTIPLE TOMES FROM THIS BATCH HAVE COME OUT THE PACKAGING WITHOUT THE ABILITY TO FULLY UNBOW. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE REPORTED EVENT MAY SUGGEST THAT THE CUTTING WIRE WILL NOT RELEASE THE BOW AFTER BEING BOWED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575839 ↗
• MalfunctionMar 11, 2026Failure to Align

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN DREAMTOME RX 44 WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PREPARATION, WAS REPORTED THAT MULTIPLE TOMES FROM THIS BATCH HAVE COME OUT THE PACKAGING WITHOUT THE ABILITY TO FULLY UNBOW. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE REPORTED EVENT MAY SUGGEST THAT THE CUTTING WIRE WILL NOT RELEASE THE BOW AFTER BEING BOWED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570738 ↗
• MalfunctionMar 11, 2026Failure to Align

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN DREAMTOME RX 44 WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PREPARATION, WAS REPORTED THAT MULTIPLE TOMES FROM THIS BATCH HAVE COME OUT THE PACKAGING WITHOUT THE ABILITY TO FULLY UNBOW. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE REPORTED EVENT MAY SUGGEST THAT THE CUTTING WIRE WILL NOT RELEASE THE BOW AFTER BEING BOWED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570733 ↗
• MalfunctionMar 11, 2026Failure to Align

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN DREAMTOME RX 44 WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PREPARATION, WAS REPORTED THAT MULTIPLE TOMES FROM THIS BATCH HAVE COME OUT THE PACKAGING WITHOUT THE ABILITY TO FULLY UNBOW. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE REPORTED EVENT MAY SUGGEST THAT THE CUTTING WIRE WILL NOT RELEASE THE BOW AFTER BEING BOWED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570732 ↗

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