Advanix™ Biliary M00534590Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729787143), received between Mar 11, 2020 and Mar 18, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• InjuryMar 18, 2026Migration

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO ADVANIX BILIARY STENTS WITH NAVIFLEX DELIVERY SYSTEMS USED IN THE SAME PATIENT. REFER TO COMPLAINT ID (B)(4) FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ADVANIX BILIARY STENTS WITH NAVIFLEX DELIVERY SYSTEMS WERE IMPLANTED TRANSDUODENALLY TO TREAT A SUSPECTED CHOLANGIOCARCINOMA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. THE ADVANIX BILIARY STENTS WERE CORRECTLY IMPLANTED. HOWEVER, ON (B)(6) 2026, THE PATIENT PRESENTED TO THE EMERGENCY ROOM; YET NO SYMPTOMS WERE REPORTED. ON (B)(6) 2026, THE PATIENT UNDERWENT A COMPUTED TOMOGRAPHY SCAN (CT), WHICH REVEALED A PERFORATED DUODENUM. IMAGING ALSO INDICATED THAT THE STENTS HAD MIGRATED DISTALLY FROM THE INTENDED IMPLANTATION SITE. THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED AND UNDERWENT SURGERY TO REPAIR THE DUODENAL PERFORATION. THE STENTS WERE NOT EXPLANTED AS A RESULT OF THIS ADVERSE EVENT AND WILL REMAIN IN PLACE UNTIL A SCHEDULED EXPLANT PROCEDURE ON (B)(6) 2026.

  Patient problems: Perforation

  MAUDE report 24626711 ↗
• InjuryMar 17, 2026Migration

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO ADVANIX BILIARY STENTS WITH NAVIFLEX DELIVERY SYSTEMS USED IN THE SAME PATIENT. REFER TO COMPLAINT ID (B)(4) FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ADVANIX BILIARY STENTS WITH NAVIFLEX DELIVERY SYSTEMS WERE IMPLANTED TRANSDUODENALLY TO TREAT A SUSPECTED CHOLANGIOCARCINOMA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. THE ADVANIX BILIARY STENTS WERE CORRECTLY IMPLANTED. HOWEVER, ON (B)(6) 2026, THE PATIENT PRESENTED TO THE EMERGENCY ROOM; YET NO SYMPTOMS WERE REPORTED. ON (B)(6) 2026, THE PATIENT UNDERWENT A COMPUTED TOMOGRAPHY SCAN (CT), WHICH REVEALED A PERFORATED DUODENUM. IMAGING ALSO INDICATED THAT THE STENTS HAD MIGRATED DISTALLY FROM THE INTENDED IMPLANTATION SITE. THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED AND UNDERWENT SURGERY TO REPAIR THE DUODENAL PERFORATION. THE STENTS WERE NOT EXPLANTED AS A RESULT OF THIS ADVERSE EVENT AND WILL REMAIN IN PLACE UNTIL A SCHEDULED EXPLANT PROCEDURE ON (B)(6) 2026.

  Patient problems: Perforation

  MAUDE report 24619265 ↗
• MalfunctionFeb 4, 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 BILIARY STENT WAS IMPLANTED IN THE COMMON BILE DUCT TO TREAT DRAINAGE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE PHYSICIAN REMOVED THE GUIDE WIRE IN PREPARATION FOR RELEASING THE STENT, IT WAS FOUND THAT IT COULD NOT BE RELEASED. THE INNER SHEATH WAS THEN FORCIBLY PULLED OUT, CAUSING DAMAGE TO THE DELIVERY SYSTEM. ADDITIONAL INFORMATION STATED THAT THE PUSHER WIRE HAD BEEN DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307170 ↗
• MalfunctionDec 19, 2022Break; Positioning Failure; Retraction Problem; Break; Positioning Failure; Retraction Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING A PROCEDURE IN THE BILE DUCT. THE EVENT DATE WAS NOT REPORTED. DURING THE PROCEDURE, IT WAS NOTED THAT WHEN PLACING THE STENT IN THE BILE DUCT, IT FAILED TO DEPLOY. ALSO, A RESISTANCE WAS OBSERVED WHEN TRYING TO INSERT THE STENT INTO THE GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16010342 ↗
• MalfunctionJan 18, 2022Break; Positioning Failure; Material Deformation; Material Split, Cut or Torn; Break; Positioning Failure; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE BILIARY PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY AND WAS STUCK IN THE DELIVERY SYSTEM. WHEN THE PHYSICIAN PULLED HARD THE DELIVERY SYSTEM, THE GUIDE CATHETER AND THE PUSH CATHETER WAS BENT. ANOTHER ADVANIX RX BILIARY STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS 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. PLEASE SEE BLOCK FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13278773 ↗
• MalfunctionMar 11, 2020Component Missing; Component Missing

  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) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE CATHETER DID NOT HAVE A RADIOPAQUE MARKER, HOWEVER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9818747 ↗