Dreamtome™ RX 49 M00584010Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729778233), received between Nov 2, 2018 and Mar 6, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (8 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-0757-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 20, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 49 WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE BILIARY SPHINCTEROTOMY PROCEDURE FOR EXTRACTION OF A CALCULI, THE CUTTING WIRE BROKE IN ITS PROXIMAL PART. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENT REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8187513 ↗
• MalfunctionNov 2, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 49 WAS USED FOR A SPHINCTEROTOMY ON OCTOBER 4, 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT AFTER EASY CATHETERIZATION, THE CUTTING WIRE BROKE AND CAME OUT OF ITS PLACE. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8035545 ↗