Advanix™ Biliary M00534640Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729787198), received between Nov 20, 2018 and Jan 9, 2026 — classified as 2 injuries, 3 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.

• InjuryJan 9, 2026Break; Difficult or Delayed Positioning

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY PRELOADED STENT WAS IMPLANTED IN THE BILE DUCT TO TREAT STONES/STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE INNER BLACK CATHETER COULD NOT BE REMOVED FULLY TO RELEASE THE STENT. THE CATHETER DETACHED FROM THE PULL WIRE. HOWEVER, THE PHYSICIAN WAS ABLE TO DEPLOY THE STENT BY REMOVING THE INNER CATHETER WITH RETRIEVAL 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 24020813 ↗
• InjurySep 22, 2025Break; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX BILIARY STENT WAS TO BE IMPLANTED IN THE DUODENUM, PROCEDURE PERFORMED ON (b)(6) 2025.DURING THE PROCEDURE, AFTER RELEASING THE STENT, THE DELIVERY DEVICE FAILED TO DETACH. PULLING ON IT CAUSED A BREAK IN THE WORKING CHANNEL. THE PROXIMAL PART WAS REMOVED, WHILE THE DISTAL PORTION REMAINED IN THE DUODENUM, STILL ATTACHED TO THE STENT. THE DETACHED CATHETER WAS REMOVED USING FORCEPS, 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 23118198 ↗
• MalfunctionMar 9, 2023Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX BILIARY STENT WAS ATTEMPTED TO BE PLACED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2023. THE REPORTED INTENDED USE WAS FOR CBD DRAINAGE AFTER STONE REMOVAL. AFTER THE STENT WAS DELIVERED INTO THE COMMON BILE DUCT, THE DELIVERY SYSTEM GUIDE CATHETER COULD NOT BE WITHDRAWN. IT WAS REPORTED THAT WHEN GUIDE CATHETER WAS PULLED OUTWARD, THE EXTERNAL TIP BECAME FRACTURED. THE GUIDE CATHETER WAS SUCCESSFULLY REMOVED, AND THE PROCEDURE WAS 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16512747 ↗
• MalfunctionMay 1, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT UPON REVIEWING HOSPITAL INVENTORY, IT WAS NOTICED THAT THERE WAS A HOLE IN THE PACKAGING OF AN ADVANIX RX BILIARY STENT AND THE STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO ISSUE NOTED WITH THE OUTER FEDERAL EXPRESS BOX THAT THE DEVICE WAS SHIPPED IN. THERE WAS NO PATIENT OR PROCEDURE INVOLVED AT THE TIME THIS INCIDENT WAS NOTICED. **ADDITIONAL INFORMATION RECEIVED ON 01MAY2019** EVENT DATE WAS REPORTED TO BE (B)(6) 2019.

  Patient problems: No Patient Involvement

  MAUDE report 8571328 ↗
• MalfunctionNov 20, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY PRELOAD STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE, PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, IT WAS NOTICED THAT THE GUIDE CATHETER BROKE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8091074 ↗