Advanix™ Biliary M00534200Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729787297), received between Oct 16, 2019 and Jan 28, 2026 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2026Break; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: RELATED AXIOS COMPLAINT IS BEING REPORTED UNDER RECORD (B)(4). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX DELIVERY SYSTEM WAS TO BE IMPLANTED TO TREAT STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE FIRST STENT; HOWEVER, THE INNER GUIDE CATHETER COMPLETELY BROKE APART. THE DEVICE SEPARATED INTO TWO OR MORE PIECES. THE PHYSICIAN THEN USED FORCEPS TO RETRIEVE THE BROKEN PIECES OF THE GUIDE CATHETER. A SECOND DEVICE WAS SUBSEQUENTLY USED, AND THE DEPLOYMENT CATHETER ALSO BROKE. IN THIS INSTANCE, THE DEVICE DID NOT SEPARATE INTO TWO OR MORE PIECES. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE. NOTE: USERS ARE STRONGLY ADVISED BY THE DFU NOT TO USE A STENT PAST THE EXPIRATION DATE ON THE PACKAGE INSERT. HOWEVER, THE DEVICES ARE TESTED BEYOND THE EXPIRATION DATE ON THE PACKAGE AND PER MEDICAL SAFETY; THE ADDITIONAL REASONABLY EXPECTED RISK OF THE USE OF THIS EXPIRED PRODUCT IS MINIMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199352 ↗
• MalfunctionDec 5, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY STENT WITH NAVIFLEX DELIVERY SYSTEM WAS TO BE USED IN THE COMMON BILE DUCT FOR DRAINAGE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS UNABLE TO BE DEPLOYED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS NOT COMPLETED. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20853362 ↗
• InjuryMay 8, 2022Break; Positioning Problem; Break; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY WITH BILIARY STENT PLACEMENT PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE PHYSICIAN DEPLOYED THE STENT, IT WAS NOTICED THAT THE GUIDE CATHETER SEEMED TO GET STUCK INTO THE STENT AND BROKE OFF WITH A PIECE OF THE BROKEN GUIDE CATHETER LODGED INTO THE DEPLOYED STENT. THE BROKEN GUIDE CATHETER WAS RETRIEVED FROM THE PATIENT WITH A RAT TOOTH GRASPING FORCEPS AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14332412 ↗
• MalfunctionApr 20, 2022Defective Device; Migration; Defective Device; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. THE ANATOMY LOCATION WAS NOT REPORTED. DURING THE PROCEDURE, IT WAS NOTED THAT THE ADVANIX BILIARY STENT HAS FAILURE MODES OF BENT OR KINKED, DIFFICULT OR FAILED TO DEPLOY, BREAK OR FRACTURED. ADDITIONALLY, IT WAS REPORTED THAT THE ADVANIX BILIARY STENT HAD A MIGRATION ISSUES . THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14155440 ↗
• MalfunctionApr 1, 2022Difficult to Remove; Migration; Difficult to Remove; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS INITIALLY IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2021. DURING A PLANNED STENT REMOVAL, THE PHYSICIAN FOUND THAT THE ADVANIX BILIARY STENT HAD MIGRATED PROXIMALLY IN THE COMMON BILE DUCT. IT WAS REPORTED THAT THEY WERE NOT ABLE TO REMOVE THE MIGRATED ADVANIX BILIARY STENT SUCCESSFULLY AND THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13978770 ↗
• InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS SUCCESSFULLY IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. POST PROCEDURE, IT WAS REPORTED THAT THE PATIENT HAD ACQUIRED INFECTION. A STENT REMOVAL PROCEDURE WAS PERFORMED ON (B)(6) 2021. IT WAS NOTED THAT THE PHYSICIAN FOUND WHITE SECRETIONS COMING OUT FROM THE DUCT. THE ADVANIX BILIARY STENT WAS REMOVED FROM THE PATIENT AND SUCCESSFULLY COMPLETED THE PROCEDURE. MEDICATION FOR INFECTION WAS PRESCRIBED TO THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FULLY RECOVERED".

  Patient problems: Unspecified Infection

  MAUDE report 12127465 ↗
• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS SUCCESSFULLY IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. POST PROCEDURE, IT WAS REPORTED THAT THE PATIENT HAD ACQUIRED INFECTION. A STENT REMOVAL PROCEDURE WAS PERFORMED. THE EVENT DATE WAS NOT REPORTED. IT WAS NOTED THAT THE PHYSICIAN FOUND A WHITE SECRETIONS COMING OUT FROM THE DUCT. THE ADVANIX BILIARY STENT WAS REMOVED FROM THE PATIENT AND SUCCESSFULLY COMPLETED THE PROCEDURE. MEDICATION FOR INFECTION WERE PRESCRIBED TO THE PATENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FULLY RECOVERED". THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

  Patient problems: Unspecified Infection

  MAUDE report 12125844 ↗
• MalfunctionSep 14, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THEY ATTEMPTED TO DEPLOY THE STENT, SEVERE RESISTANCE WAS MET. WHEN THE STENT WAS DEPLOYED, A FOREIGN OBJECT FOUND HANGING FROM THE STENT, HOWEVER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED ON THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10529363 ↗
• MalfunctionOct 16, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS TO BE USED IN A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THE PACKAGING OF ADVANIX BILIARY STENT HAD A HOLE AND THE STERILITY OF THE DEVICE WAS COMPROMISED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9199615 ↗