Advanix™ Biliary M00532230Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729787013), received between Apr 18, 2024 and Apr 18, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Stenosis” (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.
Reports received per month
Most reported problems
Device problems
- Device Stenosis1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 18, 2024Device Stenosis; Device Stenosis
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY DOUBLE PIGTAIL STENT WAS TO BE USED DURING AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2024. IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO DRAIN USING THE ADVANIX BILIARY DOUBLE PIGTAIL STENT. NO FURTHER INFORMATION HAS BEEN OBTAINED; HOWEVER, THIS MAY SUGGEST THAT THE STENT WAS OBSTRUCTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19135395 ↗
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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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