Advanix™ Biliary M00534710Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729787266), received between May 18, 2020 and Feb 5, 2026 — classified as 1 injury, 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX DELIVERY SYSTEM WAS IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE GUIDE CATHETER WAS BROKEN. HOWEVER, THE PROCEDURE WAS ABLE TO BE COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24274092 ↗
• MalfunctionAug 12, 2025Break; Positioning Failure; Use of Device Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Break; Positioning Failure; Use of Device Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS TO BE IMPLANTED IN THE DUODENUM TO TREAT A STENOSIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT DID NOT DEPLOY. THE INTRODUCER WAS INSERTED WITHOUT THE BARB FLAP COVER THROUGH THE BIOPSY CAP, AND THE GUIDEWIRE WAS PULLED BACK FROM THE STENT PRIOR TO DEPLOYMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE BARB FLAP COVER WAS NOT USED TO INSERT THE DEVICE THROUGH THE BIOPSY CAP. PER THE IFU, "SLIDE THE OUTER ORANGE SLEEVE OVER THE MOST PROXIMAL STENT BARB TO HOLD IT DOWN FOR STENT INSERTION." THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. NOTE: IT WAS REPORTED THAT THE GUIDEWIRE WAS IN THE PATIENT DURING THE ATTEMPTED DEPLOYMENT. PER THE IFU, "IF THE GUIDEWIRE IS NOT COMPLETELY RETRACTED INTO THE DELIVERY SYSTEM, THE STENT CANNOT BE FULLY DEPLOYED." THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22790642 ↗
• MalfunctionSep 1, 2023Difficult or Delayed Positioning; Adverse Event Without Identified Device or Use Problem; Difficult or Delayed Positioning; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX BILIARY STENT WAS ATTEMPTED TO BE USED TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THERE WAS NO RESISTANCE DURING THE RELEASE OF THE STENT. THE STENT DID NOT APPEAR TO BE ATTACHED TO THE SYSTEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW ADVANIX BILIARY STENT. THE PROCEDURE WAS COMPLETED AND THERE WERE NO REPORTED PATIENT COMPLICATIONS. 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 17669568 ↗
• MalfunctionMar 22, 2023Break; Premature Activation; Break; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX BILIARY STENT DEVICE WAS USED IN THE BILIARY DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILIARY STENOSIS PERFORMED ON (B)(6) 2023. DURING INSERTION, THE STENT DEPLOYED PREMATURELY IN THE WORKING CHANNEL OF THE SCOPE IN AN UNCONTROLLED MANNER. IN ORDER TO RECOVER THE STENT, THE POSITION HAD TO BE ABANDONED WITH 2 DIFFERENT WIRES (1 LEFT AND 1 RIGHT HEPATIC). THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX BILIARY STENT; HOWEVER, THE EXAMINATION WAS SIGNIFICANTLY LONGER IN AN UNSTABLE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; PROXIMAL STENT BARB WAS SLIGHTLY TORN/STENT BROKE. PLEASE SEE BLOCK FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16594984 ↗
• InjuryDec 8, 2022Migration; Migration

  IT WAS REPORTED THAT AN ADVANIX RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2022. THE STENT WAS SUCCESSFULLY IMPLANTED WITHOUT ANY ISSUES. DURING A PLANNED STENT REMOVAL PROCEDURE, ON (B)(6) 2022, IT WAS FOUND THAT THE STENT HAD MIGRATED INTO THE DUODENUM AND IMBEDDED ITSELF CAUSING A PERFORATION. IT WAS REPORTED THAT THEY PLACED MULTIPLE CLIPS TO CLOSE THE DUODENUM AND THE MIGRATED STENT WAS SUCCESSFULLY RETRIEVED USING A PAIR OF FORCEPS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER OF THE SAME ADVANIX RX BILIARY STENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND HAS SINCE BEEN DISCHARGE. DISCHARGED DATE IS UNKNOWN. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Perforation

  MAUDE report 15939443 ↗
• MalfunctionMay 18, 2020Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY STENT WAS USED DURING A PROCEDURE, PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, IT WAS NOTICED THAT THE SUTURE BROKE AND THE STENT FAILED TO DEPLOY. NO NEW STENT WAS IMPLANTED AND THE PROCEDURE WAS ABORTED DUE TO THIS EVENT. THERE WERE NO KNOWN 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 Known Impact Or Consequence To Patient

  MAUDE report 10067129 ↗