Advanix™ Biliary M00533370Recalls & reported problems
Boston Scientific Corporation · Biliary Stent · Class 2 · Implant
All models of Advanix Biliary (59)
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 08714729786740), received between Jan 6, 2021 and Jan 6, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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
- Migration1
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.
InjuryJan 6, 2021Migration; Migration
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREVIOUSLY IMPLANTED ADVANIX BILIARY STENT WAS REMOVED FROM A PATIENT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED IN THE COMMON BILE DUCT. THE IMPLANT DATE AND EXPLANT DATES WERE NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING THE PLANNED STENT REMOVAL PROCEDURE, IT WAS NOTICED THAT THE ADVANIX BILIARY STENT HAD MIGRATED DISTALLY AND PERFORATED THE DOUDENAL WALL. THE PERFORATION WAS CONFIRMED THROUGH ENDOSCOPY. THE MIGRATED STENT WAS REMOVED USING A SNARE AND THE PROCEDURE WAS COMPLETED. NO TREATMENT INFORMATION WAS REPORTED FOR THE PERFORATION. THERE WERE NO NEW STENT IMPLANTED. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO HAVE FULLY RECOVERED.
Patient problems: Perforation
MAUDE report 11123709 ↗
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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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