Advanix™ Biliary M00534370Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729787464), received between Sep 18, 2017 and May 14, 2025 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2025Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX BILIARY STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, "WHEN THE PROSTHESIS WAS RELEASED, THE CARRIER CATHETER FAILED". THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE GUIDE CATHETER WAS DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22023093 ↗
• InjuryMar 18, 2024Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY PRELOADED DOUBLE PIGTAIL STENT WAS IMPLANTED DURING A PROCEDURE ON AN UNKNOWN DATE. ON (B)(6) 2024, DURING A SCHEDULED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH A STENT REMOVAL PROCEDURE, THE PHYSICIAN WAS UNABLE TO REMOVE THE EXISTING STENT, AND DURING THE ATTEMPT AT REMOVAL, THE STENT THAT WAS ALREADY IN PLACE BROKE OFF. THE PHYSICIAN WAS ONLY ABLE TO REMOVE A PART OF THE STENT, WHILE A PART OF THE STENT REMAINED IN THE COMMON BILE DUCT. A SECOND ERCP PROCEDURE WAS SCHEDULED TO ATTEMPT THE REMOVAL OF THE REMAINING PART OF THE STENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 18925705 ↗
• InjurySep 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX¿ BILIARY STENT WAS IMPLANTED IN A PATIENT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE GALLBLADDER (EXACT IMPLANT DATE NOT REPORTED). ACCORDING TO THE COMPLAINANT, ON (B)(6) 2017, AFTER A FEW DAYS, THE DEVICE ¿AFFECTED THE CONTRA - LATERAL LINING OF THE DUODENUM, CAUSING A PERFORATION, THEREFORE REQUIRING A RE-INTERVENTION IN ORDER TO CLOSE THE LINING¿. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO ASCERTAIN THE PATIENT¿S CONDITION FOLLOWING THE PROCEDURE HAVE BEEN UNSUCCESSFUL. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Perforation

  MAUDE report 6874056 ↗