Advanix™ Biliary M00532260Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729787037), received between May 9, 2019 and Feb 24, 2026 — classified as 4 injuries, 2 malfunctions.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2026Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX STENT WAS IMPLANTED IN THE COMMON BILE DUCT TO TREAT CHOLEDOCHOLITHIASIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (b)(6) 2025.ON (b)(6) 2026; DURING THE SCHEDULED EXPLANT PROCEDURE, IT WAS NOTED THAT THE ADVANIX STENT HAD MIGRATED BACK INTO THE STOMACH, AND IT WAS EXTRACTED USING AN STANDARD GASTROSCOPE AND AN ENDOSCOPIC SNARE. THIS WAS PERFORMED WITHOUT ANY DIFFICULTY.THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24436786 ↗
• InjuryOct 13, 2023Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX BILIARY STENT WAS IMPLANTED DURING A PROCEDURE IN THE DUODENUM. THE PROCEDURE DATE IS UNKNOWN. DURING AN EMERGENT FOLLOW-UP ON (B)(6) 2023, COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND IT WAS FOUND THAT THE STENT MIGRATED, AND ONE SIDE OF THE PIGTAIL PERFORATED THROUGH THE DUODENUM INTO THE PERITONEUM. THE PERFORATED DUODENUM WAS CLOSED USING A BOSTON SCIENTIFIC MANTIS CLIP DEVICE AND THE ADVANIX BILIARY STENT WAS RETRIEVED USING RAT TOOTH FORCEPS WHICH SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WAS NO NEW STENT IMPLANTED TO REPLACE THE EXPLANTED ADVANIX BILIARY STENT. IT WAS REPORTED THAT THE PATIENT HAS EXPERIENCED SYMPTOMS CAUSING THE EMERGENT FOLLOW UP. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Perforation

  MAUDE report 17932332 ↗
• InjuryOct 16, 2019Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREVIOUSLY IMPLANTED ADVANIX BILIARY DOUBLE PIGTAIL STENT WAS REMOVED FROM A PATIENT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE COMMON BILE DUCT (CBD) PERFORMED ON (B)(6) 2019. THE EXACT IMPLANT DATE WAS NOT REPORTED. ON (B)(6) 2019, THE REPEAT ERCP PROCEDURE WAS PERFORMED AS PLANNED TO REMOVE THE STENT THAT WAS IMPLANTED IN THE COMMON BILE DUCT. PRIOR TO REMOVAL OF THE STENT, AN X-RAY WAS PERFORMED AND CONFIRMED THAT THE ADVANIX BILIARY DOUBLE PIGTAIL STENT WAS IN ITS EXPECTED PIGTAIL SHAPE IN THE CBD. ACCORDING TO THE COMPLAINANT, DURING THE PLANNED STENT REMOVAL PROCEDURE, THE ADVANIX BILIARY STENT WAS REMOVED FROM THE PATIENT'S DUCT USING RAT TOOTH FORCEPS WITHOUT ANY ISSUES. AFTER REMOVING THE STENT FROM THE DUCT, THE STENT COULD NOT BE RETRACTED THROUGH THE BIOPSY CHANNEL OF THE ENDOSCOPE. IT WAS NOTED BY THE PHYSICIAN THAT THE STENT APPEARED TO HAVE BECOME KINKED IN THREE PLACES ON THE BODY OF THE STENT DURING ATTEMPTED REMOVAL THROUGH THE SCOPE, MAKING THE REMOVAL THROUGH THE SCOPE VERY DIFFICULT. THE PHYSICIAN DECIDED TO REMOVE THE SCOPE ENTIRELY FROM THE PATIENT IN ORDER TO REMOVE THE S

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9197785 ↗
• InjuryOct 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREVIOUSLY IMPLANTED ADVANIX BILIARY STENT WAS REMOVED FROM A PATIENT DURING A PLANNED STENT REMOVAL PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON APPROXIMATELY TWO TO THREE WEEKS FOLLOWING THE STENT PLACEMENT PROCEDURE. THE STENT WAS IMPLANTED ON (B)(6) 2019 WITHOUT ANY ISSUES REPORTED. ACCORDING TO THE COMPLAINANT, APPROXIMATELY TWO TO THREE WEEKS FOLLOWING THE STENT PLACEMENT PROCEDURE, A PLANNED STENT REMOVAL WAS PERFORMED. THE PHYSICIAN NOTICED THAT THE STENT PERFORATED THE COMMON BILE DUCT OF THE PATIENT. THE STENT WAS RETRIEVED USING FORCEPS AND THE PROCEDURE WAS COMPLETED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. **CORRECTED INFORMATION RECEIVED ON 01OCT2019** THE STENT WAS IMPLANTED ON (B)(6) 2019 WITHOUT ANY ISSUES REPORTED. THE STENT WAS RETRIEVED USING A SNARE AND THE PROCEDURE WAS COMPLETED.

  Patient problems: Perforation

  MAUDE report 9167216 ↗
• MalfunctionJul 25, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN THE MIDDLE PART OF THE COMMON BILE DUCT PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE MIDDLE PART OF THE STENT WAS FRACTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT MODEL OF THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8826216 ↗
• MalfunctionMay 9, 2019Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, THE PATIENT WAS SEEN BY THE PHYSICIAN FOR A PLANNED STENT REMOVAL ON (B)(6) 2019. IT WAS NOTICED UNDER A FLOUROSCOPY THAT THE STENT MIGRATED DOWN TO THE GASTROINTESTINAL TRACT. THERE WAS NO SERIOUS INJURY, NOR WERE THERE ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8595776 ↗