Ultratome™ M00530800Recalls & reported problems
Boston Scientific Corporation · Double Lumen Sphincterotome · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729163664), received between Jul 16, 2018 and Jul 16, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning Problem” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Positioning Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2018Positioning Problem; Positioning Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME¿ WAS USED 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. THE PROCEDURE WAS COMPLETED WITH A SECOND ULTRATOME¿. 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 GOOD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7692854 ↗
Other SNARE, FLEXIBLE devices
- CAPTIFLEX M00562400Boston Scientific Corporation · SNARE, FLEXIBLE3 recalls85 reports
- SENSATION Short Throw M00562670Boston Scientific Corporation · SNARE, FLEXIBLE1 recall178 reports
- SENSATION Short Throw M00562650Boston Scientific Corporation · SNARE, FLEXIBLE1 recall173 reports
- Ultratome XL M00535900Boston Scientific Corporation · SNARE, FLEXIBLE205 reports
- CAPTIVATOR M00562340Boston Scientific Corporation · SNARE, FLEXIBLE2 recalls71 reports
- CAPTIVATOR II M00561230Boston Scientific Corporation · SNARE, FLEXIBLE1 recall83 reports
- CAPTIVATOR M00562320Boston Scientific Corporation · SNARE, FLEXIBLE2 recalls32 reports
- CAPTIVATOR M00562300Boston Scientific Corporation · SNARE, FLEXIBLE1 recall78 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
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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