Advanix™ Biliary M00533350Recalls & 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 08714729786726), received between Jul 30, 2024 and Jul 30, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination” (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
- Contamination1
- Tear, Rip or Hole in Device Packaging1
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.
MalfunctionJul 30, 2024Contamination; Tear, Rip or Hole in Device Packaging; Contamination; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX BILIARY STENT WAS TO BE USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PREPARATION, IT WAS NOTED THAT THE DEVICE PACKAGING WAS RIPPED/ TORN. THE STENT IS NO LONGER STERILE AND COULD NOT BE USED ANYMORE. ANOTHER ADVANIX-NAVIFLEX BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON AUGUST 7, 2024. IT WAS REPORTED THAT THERE IS AN AIR CUSHION ON THE TOP OF THE PRODUCTS INSIDE THE PACKAGING WHICH PREVENTS DAMAGE WHEN OPENING. FURTHERMORE, NO DAMAGE HAS BEEN OBSERVED ON THE OUTER PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19865461 ↗
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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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