Advanix™ Biliary M00534570Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729787129), received between Mar 23, 2022 and Feb 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.

• InjuryFeb 26, 2026Break; Difficult or Delayed Positioning; Entrapment of Device; Retraction Problem

  IT WAS REPORTED THAT AN ADVANIX STENT WITH NAVIFLEX DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE DISTAL COMMON BILE DUCT TO TREAT CHOLANGITIS CAUSED BY A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026 DURING ATTEMPTED DEPLOYMENT, THE HANDLE WAS UNLOCKED AND THE BLUE PULL WIRE WAS RETRACTED, ALONG WITH REMOVAL OF THE GUIDEWIRE. HOWEVER, THE STENT DID NOT DEPLOY AND REMAINED ATTACHED TO THE DELIVERY SYSTEM. THE SUTURE REMAINED INTACT, AND FURTHER RETRACTION OF THE BLUE PULL WIRE WAS NOT POSSIBLE. TO PREVENT POTENTIAL STENT MIGRATION FROM THE BILE DUCT, THE ENDOSCOPE ELEVATOR WAS USED TO STABILIZE THE STENT WHILE THE DELIVERY SYSTEM WAS WITHDRAWN. DURING WITHDRAWAL, THE BLUE PULL WIRE FRACTURED. UPON REMOVAL OF THE WHITE DELIVERY SYSTEM, IT WAS OBSERVED THAT THE BLACK INNER CATHETER REMAINED WITHIN THE LUMEN OF THE STENT, PREVENTING DISENGAGEMENT OF THE SUTURE AND SEPARATION OF THE STENT FROM THE DELIVERY SYSTEM. GRASPING FORCEPS WERE USED TO MANUALLY RETRIEVE THE BLACK INNER CATHETER WHILE MAINTAINING THE STENT POSITION WITHIN THE BILE DUCT. THE BLACK INNER CATHETER WAS SUCCESSFULLY REMOVED; HOWEVER, IT SUBSEQUENTLY BECAME L

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457830 ↗
• InjuryJan 29, 2026Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX RX BILIARY STENT WAS IMPLANTED IN THE LEFT INTRAHEPATIC DUCT (IHD) TO TREAT JAUNDICE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. THERE WAS NO SERIOUS INJURY REPORTED AND THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. SEVERAL DAYS AFTER THE INITIAL IMPLANTATION, THE PATIENT EXPERIENCED PAIN, AND THE PATIENT'S BILIRUBIN LEVELS DID NOT DECREASE AS EXPECTED. ON (B)(6) 2025, A SUBSEQUENT ERCP WAS PERFORMED, WHICH CONFIRMED DISTAL STENT MIGRATION. THE ORIGINAL STENT WAS REMOVED AND REPLACED WITH A NON-BOSTON SCIENTIFIC STENT. NO EXTENDED OBSERVATION PERIOD WAS REQUIRED, AND THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE FINE.

  Patient problems: Pain

  MAUDE report 24218181 ↗
• MalfunctionSep 19, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY RX STENT WAS TO BE USED IN THE BILE DUCT TO TREAT STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS A TEAR IN THE INNER STERILE POUCH, AND THE STERILITY OF THE DEVICE WAS COMPROMISED. ANOTHER ADVANIX BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20261740 ↗
• MalfunctionMar 23, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING A PROCEDURE. THE EXACT EVENT DATE WAS NOT PROVIDED. IT WAS REPORTED THAT THE STENT BECAME BROKEN FROM THE TIP OF THE DUODENOSCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13869264 ↗