Advanix™ Biliary M00532290Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729787051), received between Mar 18, 2021 and Jan 26, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Break; Positioning Failure; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED IN THE HEPATIC DUCT TO TREAT A BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, A 10FR X 10CM DOUBLE PIGTAIL STENT WAS PROPERLY LOADED ONTO THE ADVANIX 10FR DELIVERY SYSTEM AND POSITIONED OVER THE GUIDEWIRE. UPON DEPLOYMENT, THE RADIOPAQUE MARKER ON THE INNER CATHETER OF THE DELIVERY SYSTEM REMAINED WITHIN THE HEPATIC DUCT EVEN AFTER THE GREEN DEPLOYMENT INDICATOR ON THE HANDLE WAS ACTIVATED. THE DISTAL END OF THE INNER CATHETER WAS STILL IN PLACE AND SO THEY NEED TO REMOVE THE ENTIRE SYSTEM AND ATTEMPT THE STENT PLACEMENT AGAIN. THEY THEN DECIDED TO PROCEED WITH A DUODENAL BEND "STRAIGHT" STENT INSTEAD OF A DOUBLE PIGTAIL. THE PROCEDURE WAS COMPLETED WITH ANOTHER DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE GUIDEWIRE WAS IN THE PATIENT AND IN THE STENT DELIVERY SYSTEM DURING THE ATTEMPTED DEPLOYMENT. HOWEVER, THE ADVANIX BILIARY STENT WITH NAVIFLEX RX

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183499 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SINGLE-USE DUODENOSCOPE, AN EXTRACTOR BALLOON, A TRUETOME, AND 2 ADVANIX BILIARY STENTS WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE DUODENUM ON (B)(6) 2021 AS PART OF THE EXALT D SCOPE 01B CLINICAL STUDY. THERE WERE NO REPORTED MALFUNCTIONS ASSOCIATED WITH THE EXALT SCOPE, EXTRACTOR BALLOON, TRUETOME, OR ADVANIX BILIARY STENTS. THE PATIENT HAD A MEDICAL HISTORY OF CURRENT IMMUNOSUPPRESSION (PHARMACOLOGICALLY INDUCED) DUE TO POST-LIVER TRANSPLANT, DOCUMENTED BILIARY OR PANCREATIC STRICTURE, ABNORMAL IMAGING FINDING OF AN ANASTOMOTIC STRICTURE AND "KINK" IN PREVIOUSLY PLACED NON-BSC BILIARY STENT, 2 PREVIOUS ERCPS, PRIOR BILIARY SPHINCTEROTOMY (MAJOR PAPILLA), PRIOR STENT PLACEMENT, AND LIVER TRANSPLANTATION. ON (B)(6) 2021, THE PATIENT EXPERIENCED AN ADVERSE EVENT OF POSSIBLE CHOLANGITIS AND A FEVER WITH SOME INCREASE IN WHITE COUNT AS A SYMPTOM OF THE CHOLANGITIS. AS A RESULT, THE PATIENT WAS HOSPITALIZED ON (B)(6) 2021. THE FEVER CAME DOWN QUICKLY AFTER TREATMENT. THE PATIENT WAS TREATED WITH ZOSYN IV X 2 DAYS; CIPRO/FLAGYL AS OUTPATIENT. BLOOD CULTURES W

  Patient problems: Inflammation

  MAUDE report 11519767 ↗