Dreamtome™ RX 44 M00584060Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729778288), received between Mar 27, 2018 and Feb 5, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

1 FDA recall record name this device's identifier, 1 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, 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.

Recalls naming this device

1. Dec 22, 2021Class IIOpen, Classified

   Sterility of device is compromised due to a sterile barrier breach

   Z-0752-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2025Break; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Break; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE DUODENAL PAPILLA WAS READY TO BE CUT, THE DREAMTOME WAS FRACTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DREAMTOME RX 44. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE REPORTED EVENT MAY SUGGEST A CUTTING WIRE BREAK. 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. ***ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 18, 2025*** A PHOTO OF THE DEVICE WAS PROVIDED BY THE COMPLAINANT AND SHOWED THAT THE WIRE ANCHOR DISLODGED FROM THE CATHETER. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO CUT THROUGH ABNORMAL TISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21314911 ↗
• MalfunctionDec 28, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A DREAMTOME RX 44 WAS CHECKED AFTER BEING RECEIVED IN A BSC WAREHOUSE ON (B)(6) 2024. FOREIGN MATERIAL WAS FOUND INSIDE THE UNOPENED POUCH OF THE DEVICE. IT WAS REPORTED THAT THE STERILE SEAL WAS NOT COMPROMISED, AS ALL PACKAGING SEALS WERE INTACT. THERE WAS NO HEALTHCARE FACILITY, PROCEDURE OR PATIENT INVOLVED IN THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED, AND A BLUE COLORED FOREIGN MATERIAL CAN BE SEEN INSIDE THE STERILE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21031495 ↗
• MalfunctionDec 10, 2024Break; Detachment of Device or Device Component; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS BEING PREPARED FOR USE IN THE INTESTINAL TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO BE PERFORMED ON (B)(6) 2024. DURING PREPARATION, WHEN THE DEVICE PACKAGING WAS OPENED FOR USE, THE DREAMTOME TIP WAS FOUND TO BE MISSING. IT WAS REPORTED THAT THE COMPONENTS SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DREAMTOME RX 44. 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 20897530 ↗
• MalfunctionFeb 16, 2022Defective Device; Device Dislodged or Dislocated; Material Deformation; Material Split, Cut or Torn; Defective Device; Device Dislodged or Dislocated; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS INTENDED TO BE USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING PREPARATION OUTSIDE THE PATIENT, IT WAS NOTICED THAT THE DEVICE WAS DAMAGED. 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 RESULTS: THE CUTTING WIRE ANCHOR WAS DISLODGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13544284 ↗
• MalfunctionJan 5, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE CUTTING WIRE OF THE DREAMTOME RX 44 BROKE. IT WAS REPORTED THAT THE CUTTING WIRE WAS INTACT BUT THE WIRE ANCHOR WAS DISLODGED FROM THE CATHETER. ADDITIONALLY, 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 13168352 ↗
• MalfunctionNov 24, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS USED IN THE BILIARY DUCTS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT THE CUTTING WIRE OF DREAMTOME RX 44 SPARKED AND WAS DEFORMED. IT WAS REPORTED THAT THE CUTTING WIRE WAS BROKEN AND DISTORTED WHICH COULD NOT BE USED IF THE PHYSICIAN WANTED TO INCISE THE PAPILLA. ADDITIONALLY, 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 12870824 ↗
• MalfunctionNov 24, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS USED IN THE BILIARY DUCTS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT THE CUTTING WIRE OF DREAMTOME RX 44 SPARKED AND WAS DEFORMED. IT WAS REPORTED THAT THE CUTTING WIRE WAS BROKEN AND WARPED WHICH COULD NOT BE USED IF THE PHYSICIAN WANTED TO INCISE THE PAPILLA. ADDITIONALLY, 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 12870790 ↗
• MalfunctionNov 17, 2021Failure to Align; Material Deformation; Material Twisted/Bent; Positioning Problem; Failure to Align; Material Deformation; Material Twisted/Bent; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS USED IN THE BILIARY DUCTS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, "THE CUTTING LINE MOVED A LOT AND THE STATION WAGON DID NOT STAY IN PLACE PROPERLY. THE SYSTEM STRETCHED AND RELAXED." WHEN THE PHYSICIAN PRESSED THE PEDAL ENERGIZING THE DEVICE TO CUT THE PAPILLA, IT WAS NOTICED THAT THE CUTTING WIRE WAS COMPLETELY TWISTED. IT WAS REPORTED THAT THE ORIENTATION OF CUTTING WIRE AND THE CATHETER WERE BOTH INCORRECT. ADDITIONALLY, THE ENTIRE LENGTH OF THE CUTTING WIRE WAS COMPLETELY BENT AND UNUSABLE. 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. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. THE REPORTED EVENT MAY SUGGEST THAT THE ORIENTATION OF THE CUTTING WIRE WAS INCORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12830171 ↗
• MalfunctionJan 29, 2019Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A DREAMTOME RX 44 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE ORIENTATION OF THE TOME'S CUTTING WIRE WAS NOT ORIENTED TO THE SATISFACTION OF THE PHYSICIAN. THE TOME WAS ORIENTED AT MORE OF A 12:30 ORIENTATION, BUT THE PHYSICIAN WANTED AN 11 O'CLOCK ORIENTATION. THERE WERE NO INJURY NOR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8287520 ↗
• MalfunctionOct 29, 2018Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  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 PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, WHEN THEY ATTEMPTED TO PERFORM SPHINCTEROTOMY, THE CUTTING WIRE DID NOT BOW. REPORTEDLY, THERE WAS NO VISIBLE DAMAGE NOTED ON THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A NEW DREAMTOME RX 44. THERE WERE NO USER INJURIES NOR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; CUTTING WIRE PARTIALLY DISLODGED FROM THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8017630 ↗
• MalfunctionAug 30, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MFR REPORT# 3005099803-2018-60199 FOR THE FIRST DREAMTOME AND MFR REPORT# 3005099803-2018-60204 FOR THE SECOND DREAMTOME. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS UNPACKED FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THERE WAS A COTTON-LIKE MATERIAL ON THE DEVICE. A SECOND DREAMTOME WAS UNPACKED AND THE SAME COTTON-LIKE MATERIAL WAS OBSERVED. THE  PROCEDURE WAS COMPLETED WITH A THIRD DREAMTOME RX 44. THERE WERE NO USER INJURY NOR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7833406 ↗
• MalfunctionAug 30, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MFR REPORT# 3005099803-2018-60199 FOR THE FIRST DREAMTOME AND MFR REPORT# 3005099803-2018-60204 FOR THE SECOND DREAMTOME. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS UNPACKED FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THERE WAS A COTTON-LIKE MATERIAL ON THE DEVICE. A SECOND DREAMTOME WAS UNPACKED AND THE SAME COTTON-LIKE MATERIAL WAS OBSERVED. THE  PROCEDURE WAS COMPLETED WITH A THIRD DREAMTOME RX 44. THERE WERE NO USER INJURY NOR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7833404 ↗
• MalfunctionMar 27, 2018Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME¿ RX 44 WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE CUT WIRE WAS ORIENTED IN THE WRONG DIRECTION. REPORTEDLY, THERE WAS NO TORTUOUS ANATOMY IMPACTING SCOPE POSITIONING AND NO VISIBLE DAMAGE TO THE DEVICE PRIOR TO PUTTING IT THROUGH THE SCOPE OR AFTER THE ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A SECOND DREAMTOME¿ RX 44. 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 7375036 ↗