Advanix™ Biliary M00534260Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729787358), received between Sep 1, 2021 and Dec 26, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED IN THE BILE DUCT FOR A CHOLEDOCALITHIASIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE NURSE TRIED TO SHORTEN THE INTRODUCER BUT IT WAS NOT WORKING AND IT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23899170 ↗
• MalfunctionFeb 16, 2024Break; Use of Device Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Break; Use of Device Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY WAS IMPLANTED IN THE BILE DUCT FOR BILE DRAINAGE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS A THREAD HANGING ON THE STENT. THE ADVANIX BILIARY STENT REMAINS IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON A MEDIA INSPECTION OF THE PHOTO PROVIDED BY THE CUSTOMER THAT DETERMINED THE STENT BARB WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18727964 ↗
• InjuryDec 7, 2023Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY PRELOADED DOUBLE BEND STENT WAS IMPLANTED IN THE DUODENUM TO TREAT A BILE FLOW BLOCKAGE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE TECHNICIAN PULLED THE STENT FORCEFULLY CAUSING THE BLACK INTRODUCER TO DETACH FROM THE DELIVERY SYSTEM INSIDE THE PATIENT. WHEN THE SCOPE WAS REMOVED, THE DETACHED BLACK INTRODUCER REMAINED IN THE PATIENT'S DUODENUM. THE TECHNICIAN ATTEMPTED TO RETRIEVE THE DETACHED INTRODUCER USING FORCEPS AND A SNARE BUT WAS UNSUCCESSFUL. AN UPPER SCOPE WAS THEN USED ALONG WITH A SNARE TO SUCCESSFULLY REMOVED THE DETACHED BLACK INTRODUCER. THE STENT REMAINED IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE GUIDEWIRE WAS INSIDE THE PATIENT DURING THE ATTEMPTED DEPLOYMENT. HOWEVER, THE ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU) STATES, "FOR PRELOADED SYSTEM ONLY: IF THE GUIDEWIRE IS NOT COMPLETELY RETRACTED INTO THE ENDOSCOPE, THE STENT CANNOT BE FULLY DEPLOYED." THE PHYSICIAN DID N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18282443 ↗
• MalfunctionJan 12, 2022Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE BILE DUCT, PERFORMED ON AN (B)(6) 2021. POST PROCEDURE, ON (B)(6) 2021, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT WITH A SNARE, IT WAS DIFFICULT TO REMOVE. THE PROXIMAL FLANGE WAS PERPENDICULAR WHEN REMOVED AND CAUSED TRAUMA INSIDE THE PATIENTS' BILE DUCT AND HAD TO DRAIN THE FLUID. ANOTHER ADVANIX BILIARY STENT WAS IMPLANTED TO THE PATIENT AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WAS NO PATIENT COMPLICATION OF LACERATION REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO HAVE FULLY RECOVERED.

  Patient problems: Laceration(s)

  MAUDE report 13237892 ↗
• MalfunctionSep 1, 2021Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE PHYSICIAN COULD NOT DEPLOY THE STENT AND IT WAS FOUND THAT THE SUTURE STRING BECAME BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. 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 STABLE. INVESTIGATION RESULTS REVEALED THAT THE STENT BROKEN, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12408577 ↗