Advanix™ Biliary M00533380Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729786757), received between Jan 6, 2021 and Mar 6, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Migration” (3 reports).

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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS IMPLANTED IN THE DUODENUM DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE PHYSICIAN INFORMED THAT A PATIENT SUFFERED A DUODENAL PERFORATION AFTER PLACING THE ADVANIX BILIARY STENT THE PATIENT WAS HOSPITALIZED.

  Patient problems: Perforation

  MAUDE report 24532402 ↗
• InjuryJan 6, 2022Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS IMPLANTED IN THE PATIENT ON AN UNKNOWN DATE. ON (B)(6) 2021, IT WAS NOTICED THAT THE STENT MIGRATED DISTALLY FROM THE COMMON BILE DUCT INTO THE DUODENUM. A SMALL PERFORATION OCCURRED IN THE DUODENUM AS A RESULT OF MIGRATION. THE STENT WAS REMOVED AND THE PERFORATION WAS CLOSED WITH CLIPS. NO NEW STENT WAS IMPLANTED IN PLACE OF THE MIGRATED STENT. ACCORDING TO THE PHYSICIAN, THE PATIENT IS "OKAY".

  Patient problems: Perforation

  MAUDE report 13179650 ↗
• InjuryDec 21, 2021Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS IMPLANTED IN THE PATIENT ON AN UNKNOWN DATE. ON (B)(6) 2021, IT WAS NOTICED THAT THE STENT MIGRATED DISTALLY FROM THE COMMON BILE DUCT INTO THE DUODENUM. A SMALL PERFORATION OCCURRED IN THE DUODENUM AS A RESULT OF MIGRATION. THE STENT WAS REMOVED AND THE PERFORATION WAS CLOSED WITH CLIPS. NO NEW STENT WAS IMPLANTED IN PLACE OF THE MIGRATED STENT. ACCORDING TO THE PHYSICIAN, THE PATIENT IS "OKAY".

  Patient problems: Perforation

  MAUDE report 13051813 ↗
• 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 PAIR OF BIOPSY FORCEPS 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 11123717 ↗