Advanix™ Biliary M00534650Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729787204), received between Feb 23, 2021 and Jan 21, 2026 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2026Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE INTRODUCER BROKE OFF INSIDE STENT. IT WAS THEN REMOVED WITH GRASPING FORCEPS AND STENT STAYED IN DESIRED POSITION. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE GUIDEWIRE WAS IN THE CATHETER 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 24131878 ↗
• InjuryJun 11, 2025Break; Difficult or Delayed Positioning; Adverse Event Without Identified Device or Use Problem; Break; Difficult or Delayed Positioning; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS IMPLANTED IN THE BILIARY DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CATHETER WAS CRACKED MAKING IT DIFFICULT TO RELEASE THE STENT. THE CATHETER WAS HELD FIRMLY, AND FORCEPS WAS USED TO RELEASE THE STENT. THE STENT WAS SUCCESSFULLY DEPLOYED, 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 22189142 ↗
• InjuryMar 12, 2025Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX STENT WITH NAVIFLEX DELIVERY SYSTEM WAS IMPLANTED TO TREAT JAUNDICE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. A FEW DAYS AFTER THE STENT WAS IMPLANTED, IT WAS NOTED THAT IT MIGRATED DISTALLY CAUSING THE PATIENT A PERFORATION. THE STENT HAS BEEN SUBSEQUENTLY EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 21586829 ↗
• MalfunctionMar 7, 2025Break; Retraction Problem; Break; Retraction Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY PRELOADED CENTER BEND STENT WAS USED IN THE BILE DUCT TO TREAT STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STEEL STYLET COULD NOT BE RETRACTED TO ADJUST THE GUIDE CATHETER OF THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX BILIARY PRELOADED 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 RESULTS WHICH REVEALED THAT THE GUIDE CATHETER WAS DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21549162 ↗
• MalfunctionJan 21, 2025Break; 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 NAVIFLEX STENT WAS USED FOR DRAINAGE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE PHYSICIAN REMOVED THE GUIDEWIRE IN PREPARATION FOR RELEASING THE STENT, HE NOTICED THAT THE STENT COULD NOT BE RELEASED. THE INNER SHEATH WAS FORCIBLY PULLED OUT THAT CAUSED THE DELIVERY SYSTEM DAMAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO KNOWN PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21201945 ↗
• InjuryMay 23, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX RX BILIARY STENT WAS TO BE IMPLANTED IN THE BILE DUCT FOR BILE DUCT DRAINAGE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED IN THE PATIENT'S BILE DUCT; HOWEVER, THE GUIDE CATHETER GOT DETACHED FROM THE ENTIRE DEVICE. THE DETACHED CATHETER WAS REMOVED USING A FOREIGN BODY FORCEPS WITHOUT MOBILIZING THE STENT. 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 19382683 ↗
• InjuryMar 18, 2021Difficult to Remove; Migration; Difficult to Remove; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREVIOUSLY IMPLANTED ADVANIX RX BILIARY STENT WAS REMOVED FROM A PATIENT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE BILIARY DUCTS AND PAPILLA PERFORMED ON (B)(6) 2021. ON (B)(6) 2020, AN ADVANIX RX BILIARY STENT WAS SUCCESSFULLY IMPLANTED WITHOUT ANY PROBLEM. IT WAS REPORTED THAT THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2021 DUE TO ABDOMINAL PAIN. THE PHYSICIAN FOUND WITH THE ENDOSCOPE THAT THE STENT HAD MIGRATED IN THE DUODENUM WALL LEADING TO HAVE SOME BLEEDING. REPORTEDLY, THE PHYSICIAN EXPERIENCED DIFFICULT REMOVING THE STENT AS IT STAYED TANGENTIAL TO THE WALL OF THE DUODENUM AND PERFORATED THE DUODENUM WALL. THE MIGRATED STENT WAS SUCCESSFULLY REMOVED WITH A SNARE AND A NEW STENT WAS NOT IMPLANTED. 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: Abdominal Pain; Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 11517096 ↗
• InjuryFeb 23, 2021Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT AN ADVANIX BILIARY STENT WAS IMPLANTED, ALONG WITH THREE OTHER STENTS, IN THE COMMON BILE DUCT TO TREAT A BILIARY STENOSIS DUE TO LIVER TRANSPLANT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2021, DURING EMERGENT FOLLOW-UP, IT WAS NOTICED THAT THE ADVANIX BILIARY STENT HAD MIGRATED OUTSIDE THE PAPILLA. REPORTEDLY, ON (B)(6) 2021, THE MIGRATED STENT WAS SUCCESSFULLY REMOVED FROM THE DUODENUM USING A SNARE AND A NEW STENT WAS NOT IMPLANTED. 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 11366850 ↗