Advanix™ Biliary M00534720Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729787273), received between Nov 18, 2024 and Mar 26, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY STENT WITH NAVIFLEX DELIVERY SYSTEM WAS ATTEMPTED TO BE IMPLANTED IN THE BILE DUCT (HILAR REGION) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHILE DEPLOYING THE PLASTIC STENT, SIGNIFICANT TIGHTNESS IN THE AREA CAUSED THE BLACK INTRODUCER TO DETACH FROM THE DELIVERY SYSTEM AND BECOME LODGED WITHIN THE STENT. AS A RESULT, BOTH THE STENT AND THE DETACHED BLACK INTRODUCER REMAINED INSIDE THE PATIENT. SUBSEQUENTLY, BOTH THE STENT AND THE INTRODUCER WERE SUCCESSFULLY REMOVED. 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24704997 ↗
• InjuryMay 15, 2025Migration; Migration

  THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2025-01746 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ADVANIX BILIARY STENTS WITH NAVIFLEX RX DELIVERY SYSTEM WERE IMPLANTED BILATERALLY INTO THE RIGHT AND LEFT HEPATIC DUCTS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2024. POST STENT PLACEMENT, TWO ADVANIX STENTS (SUBJECT OF THIS REPORT) AND (SUBJECT OF MANUFACTURER REPORT #3005099803-2025-01746) HAD MIGRATED CAUSING PERFORATION IN THE OPPOSITE WALL OF THE DUODENUM. ON (B)(6) 2024. THE TWO ADVANIX STENTS WERE REMOVED USING GRASPING FORCEPS. THE PATIENT IS CURRENTLY WELL AND IS BEING RE-ASSESSED FOR TREATMENT OPTIONS FOR HER LIKELY CHOLANGIOCARCINOMA WHICH IS PERI HILAR.

  Patient problems: Perforation

  MAUDE report 22030404 ↗
• InjuryApr 24, 2025Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS IMPLANTED IN THE DUODENAL WALL DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON AN UNKNOWN DATE. POST STENT PLACEMENT, THE ADVANIX STENT HAD MIGRATED AND PERFORATED THROUGH THE OPPOSITE SIDE OF THE DUODENAL WALL.

  Patient problems: Perforation

  MAUDE report 21903405 ↗
• MalfunctionNov 18, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY PRELOADED STENT WAS USED TO TREAT A STRICTURE IN THE BILIARY DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE INNER CATHETER SNAPPED OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS SUCCESSFULLY REMOVED USING GRASPING FORCEPS. THE PROCEDURE WAS THEN COMPLETED USING ANOTHER DEVICE OF THE SAME TYPE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 15, 2024: 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."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20709888 ↗