Dreamtome™ RX 44 M00584070Recalls & reported problems
Boston Scientific Corporation · Sphincterotome · Class 2
All models of Dreamtome RX 44 (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729778295), received between Oct 5, 2022 and Oct 5, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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
- Dec 22, 2021Class IIOpen, Classified
Sterility of device is compromised due to a sterile barrier breach
Z-0754-2022 · Root cause: Packaging process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1
Patient problems
- Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 5, 2022Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE CUTTING WIRE OF THE DREAMTOME RX 44 BROKE DURING THE SPHINCTEROTOMY, CAUSING SUPERFICIAL MUCOSAL PERFORATION. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Patient problems: Perforation
MAUDE report 15544106 ↗
Other Unit, electrosurgical, endoscopic (with or without accessories) devices
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- Single Use Electrosurgical Knife KD-611LOlympus Medical Systems Corp. · Unit, electrosurgical, endoscopic (with or without accessories)1 death357 reports
- Autotome™ RX 44 M00545170Boston Scientific Corporation · Unit, electrosurgical, endoscopic (with or without accessories)1 recall262 reports
- TRUEtome 44 M00584170Boston Scientific Corporation · Unit, electrosurgical, endoscopic (with or without accessories)237 reports
- Dreamtome™ RX 44 M00584040Boston Scientific Corporation · Unit, electrosurgical, endoscopic (with or without accessories)1 recall165 reports
- Dreamtome™ RX 44 M00584050Boston Scientific Corporation · Unit, electrosurgical, endoscopic (with or without accessories)1 recall127 reports
- Single Use 3-Lumen Sphincterotome V KD-V411M-0725Olympus Medical Systems Corp. · Unit, electrosurgical, endoscopic (with or without accessories)160 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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