Advanix™ Biliary M00534630Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729787181), received between Jan 8, 2025 and Aug 14, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2025Positioning Failure; Retraction Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Retraction Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ADVANIX-NAVIFLEX RX BILIARY STENT WAS TO BE IMPLANTED TO TREAT A COMMON BILE DUCT (CBD) STRICTURE IN THE SECTION PORTION OF DUODENAL, NEXT TO PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE THE TECHNICIAN NOTED THAT PULLING THE REAR WIRE DID NOT ADVANCE THE STENT. UPON INSPECTION, THE LOCKING MECHANISM WAS CONFIRMED TO BE IN THE UNLOCKED POSITION. ANOTHER ADVANIX-NAVIFLEX RX BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULT WHICH REVEALED THAT GUIDE CATHETER WAS DETACHED. PLEASE SEE BLOCK H11 FOR THE FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22804607 ↗
• MalfunctionJun 25, 2025Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ADVANIX STENT WITH NAVIFLEX DELIVERY SYSTEM WAS TO BE IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE ATTEMPTED TO DEPLOY THE STENT, THE BLACK CATHETER REMAINED IN THE STENT AND THE STENT WAS NOT ABLE TO DEPLOY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329539 ↗
• MalfunctionJun 12, 2025Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS TO BE IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE ATTEMPTED TO DEPLOY THE STENT IN THE PATIENT, THE BLACK CATHETER REMAINED IN THE STENT AND THE STENT WAS NOT ABLE TO DEPLOY APPROPRIATELY. ANOTHER ADVANIX-NAVIFLEX BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196353 ↗
• MalfunctionMay 15, 2025Break; Difficult or Delayed Positioning; Adverse Event Without Identified Device or Use Problem; Break; Difficult or Delayed Positioning; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS TIGHT. DURING THE PROCEDURE, THE ADVANIX BILIARY STENT WAS DIFFICULT TO DEPLOY. ANOTHER ADVANIX DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULT WHICH REVEALED THAT THE GUIDE CATHETER WAS DETACHED. PLEASE SEE BLOCK H11 FOR THE FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22030707 ↗
• MalfunctionJan 8, 2025Contamination; Unsealed Device Packaging; Contamination; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORTATION THAT AN ADVANIX RX BILIARY PRELOADED STENT WAS TO BE USED IN A PROCEDURE. DURING PREPARATION, IT WAS OBSERVED THAT THE PRIMARY PACKAGING WAS UNSEALED, WITH NO EVIDENCE OF HEAT SEALING ON THE LOWER PORTION OF THE PACKAGING. AS A RESULT, THE PRODUCT WAS DEEMED NON-STERILE AND UNSUITABLE FOR USE. NO PATIENT WAS INVOLVED IN THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21102215 ↗