Advanix™ Biliary M00534220Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729787310), received between May 29, 2018 and Jan 12, 2026 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2026Break; Use of Device Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED IN THE COMMON BILE DUCT FOR STENT PLACEMENT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE WIRE BROKE FROM THE DELIVERY SYSTEM. THE STENT WAS PLACED BUT HAD TO BE REPOSITIONED FROM WITH RAT TOOTH FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE GUIDEWIRE WAS IN 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 CAN NOT BE FULLY DEPLOYED." THE PHYSICIAN DID NOT FOLLOW THE STEPS CITED IN THE IFU. THEREFORE, AR CODE (5191: 2457) WAS USED TO CAPTURE USER ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24039855 ↗
• InjuryNov 26, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS TO BE IMPLANTED IN THE BILIARY DUCT TO TREAT A BILIARY STENOSIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE ADVANIX STENT WAS DEPLOYED. HOWEVER, WHEN THE GUIDEWIRE WAS REMOVED, THE GUIDE CATHETER WAS STUCK INSIDE THE DEPLOYED STENT AND WAS NOTED TO BE BROKEN. THE DETACHED GUIDE CATHETER WAS REMOVED USING FORCEPS. THE STENT REMAINS IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20786785 ↗
• MalfunctionMay 13, 2024Positioning Failure; Material Split, Cut or Torn; Positioning Failure; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY AND NAVIFLEX RX DELIVERY SYSTEM WAS TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF A STENT BARB TORN. PLEASE SEE BLOCK H10 FOR THE FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19306957 ↗
• MalfunctionSep 29, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC (BSC) THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS SELECTED FOR USE IN THE PAPILLA/DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, ALTHOUGH THE GUIDEWIRE AND INNER CATHETER WERE RETRACTED AS INSTRUCTED PER THE DEVICE'S INSTRUCTIONS FOR USE, THE STENT DID NOT DEPLOY. THE ADVANIX BILIARY STENT WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE GUIDE CATHETER WAS DETACHED/SEPARATED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17844612 ↗
• InjuryMar 8, 2023Break; Positioning Failure; Retraction Problem; Break; Positioning Failure; Retraction Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX BILIARY STENT WAS ATTEMPTED TO BE PLACED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2023. DURING STENT PLACEMENT IN A VERY SICK PATIENT WITH A TIGHT STRICTURE, THE STENT WOULD NOT RELEASE FROM THE DELIVERY SYSTEM. ATTEMPTS WERE MADE TO PULL THE STENT AND DELIVERY SYSTEM BACK THROUGH THE SCOPE, BUT THE GUIDE CATHETER AND STENT GOT STUCK IN THE BILE DUCT. THE DELIVERY SYSTEM AND HALF OF THE GUIDE CATHETER WERE REMOVED THROUGH THE SCOPE. THE OTHER HALF OF THE GUIDE CATHETER AND THE STENT WERE SUCCESSFULLY REMOVED FROM THE BILE DUCT USING RAT TOOTH FORCEPS. THE PROCEDURE TO CREATE FLOW IN THE DUCT WAS COMPLETED USING A NEW ADVANIX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16509277 ↗
• MalfunctionJun 5, 2022Break; Positioning Failure; Material Deformation; Adverse Event Without Identified Device or Use Problem; Break; Positioning Failure; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE DUODENAL PAPILLA, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE STENT FAILED TO DEPLOY AND IT WAS NOTICED THAT THE PUSH CATHETER AND GUIDE CATHETER BROKE. THE BROKEN GUIDE CATHETER AND PUSH CATHETER REMAINED IN ONE PIECE WITHIN THE DELIVERY SYSTEM ENABLING IT TO BE REMOVED ON ONE PIECE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE METHOD. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE PULLWIRE WAS KINKED AND THE PUSH CATHETER WAS BROKEN. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14599618 ↗
• MalfunctionApr 4, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE BILE DUCT PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN ADVANCING THE STENT INTO THE BILE DUCT, IT DEPLOYED PREMATURELY EVEN THOUGH THE HANDLE WAS IN THE LOCKED POSITION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE STENT DAMAGED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13995619 ↗
• InjuryFeb 23, 2021Break; Break

  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) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, IT WAS NOTICED THAT THE GUIDE CATHETER BROKE. THE BROKEN PIECE OF GUIDE CATHETER WAS RETRIEVED WITH A USE OF A PAIR OF GRASPING FOCEPS. ANOTHER ADVANIX RX BILIARY STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. 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 OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11366849 ↗
• MalfunctionFeb 8, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE BILIARY. THE EXACT DATE OF THE PROCEDURE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE GUIDEWIRE WAS STUCK AND THE STENT FAILED TO DEPLOY. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF GUIDE CATHETER DETACHED/SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11298592 ↗
• InjuryMay 6, 2019Break; Premature Activation; Difficult to Remove; Break; Premature Activation; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE BILE DUCT OF A PATIENT ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT THROUGH THE STRICTURE IN THE BILE DUCT, THE SUTURE BROKE AND THE STENT PREMATURELY DEPLOYED AND BECAME STUCK IN THE PATIENT'S DUCT. THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT USING SNARES AND FORCEPS, HOWEVER, UPON ATTEMPTED REMOVAL, THE STENT TORE MULTIPLE TIMES. THE PROCEDURE WAS COMPLETED BY LEAVING THE REMAINING STENT IN PLACE AND THE BROKEN STENT PIECES WERE LEFT TO PASS OUT THE PATIENT NATURALLY. THE PHYSICIAN NOTED THAT THE TREATMENT LOCATION WAS A SUTURED BILE DUCT (SURGICAL COMPLICATION OF LAPAROSCOPIC CHOLECYSTECTOMY). 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8582224 ↗
• MalfunctionMay 29, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY STENT WAS IMPLANTED IN A PATIENT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING A PTC (PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY) RENDEVOUS CASE WHERE THE GUIDEWIRE WAS PLACED BY INTERVENTIONAL RADIOLOGY, THE ADVANAIX STENT WAS PLACED USING THE GUIDEWIRE. WHEN THE PHYSICIAN WAS GOING TO DEPLOY THE STENT, HE REQUESTED THE GUIDEWIRE BE CUT BY THE BIOPSY CHANNEL OF THE DUODENOCOPE. THE PHYSICIAN REQUESTED THE GUIDEWIRE TO BE CUT TO PREVENT CONTAMINATION, AS THE PHYSICIAN WAS EXPECTING THIS PORTION OF THE GUIDEWIRE TO BE PULLED BACK THROUGH THE PATIENT'S LIVER. THE CUT PORTION OF THE GUIDEWIRE WAS ATTEMPTED TO BE REMOVED FROM THE PATIENT VIA THE PTC SITE BUT BECAME STUCK WHEN REMOVING FROM THE PATIENT. THE PHYSICIAN ASKED FOR THE STENT TO BE DEPLOYED WITH THE GUIDEWIRE STILL IN PLACE. AFTER DEPLOYMENT, THE GUIDEWIRE WAS STILL UNABLE TO BE REMOVED FROM THE PATIENT VIA THE PTC SITE, SO THE PHYSICIAN REMOVED THE DELIVERY CATHETER AND GUIDEWIRE THROUGH THE ERCP SCOPE. ALL DEVICES WERE REMOVED FROM THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7549748 ↗