RX Biliary M00545600Recalls & reported problems
Boston Scientific Corporation · Biliary Stent with RX Delivery System · Class 2 · Implant
All models of RX Biliary (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729337904), received between Nov 9, 2020 and Nov 9, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 9, 2020Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE BILE DUCT PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS INSERTED IN THE SCOPE AND UPON REACHING INTO THE PATIENT, THE TIP OF THE GUIDE CATHETER BROKE AND IT WAS RETRIEVED WITH A SNARE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA RX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10808726 ↗
Other CATHETER, BILIARY, DIAGNOSTIC devices
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- CRE™ PRO M00558710Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC1 recall284 reports
- Hurricane™ RX M00545920Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls211 reports
- MUSTANG™ H74939171070470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC265 reports
- MUSTANG™ H74939171050470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC212 reports
- Hurricane™ RX M00545940Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls109 reports
- MUSTANG™ H74939171100470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC203 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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