Advanix™ Biliary M00532210Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729786993), received between Nov 16, 2016 and Mar 27, 2025 — classified as 1 injury, 8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2025Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX BILIARY STENT WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BLACK INNER SHEATH WAS DETACHED DURING DEPLOYMENT. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21710127 ↗
• MalfunctionSep 21, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR STONE REMOVAL PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT THE STENT PIGTAIL WAS NOT CURLED ENOUGH AND IT MAY SLIP OUT FROM THE COMMON BILE DUCT. THE ADVANIX BILIARY STENT WAS REMOVED, AND A NON-BOSTON SCIENTIFIC DEVICE WAS OPENED AND USED TO SUCCESSFULLY 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 17795190 ↗
• InjuryMar 1, 2023Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT AN ADVANIX BILIARY STENT WAS SUCCESSFULLY IMPLANTED DURING A LIVER TRANSPLANT PROCEDURE DUE TO HILAR STENOSIS PERFORMED ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT EXPERIENCED POST BLEEDING SPHINCTEROTOMY. THE PHYSICIAN THEN NOTICED THAT THE STENT HAD MIGRATED INTO THE JEJUNUM. THE MIGRATED ADVANIX BILIARY STENT WAS SUCCESSFULLY REMOVED USING A RAT TOOTH DEVICE AND A NEW STENT WAS PLACED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THERE WAS NO RELATIONSHIP BETWEEN THE TO THE ADVANIX BILIARY STENT AND THE POST BLEEDING SPHINCTEROTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16464537 ↗
• MalfunctionOct 19, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE IN THE BILIARY PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS REPORTED THAT THE STENT BENDS AND BENDS WHEN ENTERING THE BILIARY TRACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. INVESTIGATION RESULTS REVEALED THAT THE STENT WAS DETACHED/SEPARATED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12655396 ↗
• MalfunctionOct 11, 2021Material Deformation; Material Deformation

  AN ADVANIX BILIARY STENT WAS RETURNED TO BOSTON SCIENTIFIC CORPORATION. THIS PRODUCT WAS RETURNED TO THE MANUFACTURER WITHOUT ANY REPORT OF PERFORMANCE ISSUES OR ADVERSE PATIENT EFFECTS. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS; STENT DAMAGED. PLEASE SEE FULL INVESTIGATION DETAILS.

  Patient problems: Insufficient Information

  MAUDE report 12604646 ↗
• MalfunctionSep 27, 2021Premature Activation; Use of Device Problem; Premature Activation; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN THE COMMON BILE DUCT PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS REPORTED THAT THE STENT DEPLOYED PREMATURELY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. INVESTIGATION RESULTS REVEALED THAT THE STENT WAS DAMAGED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12531949 ↗
• MalfunctionNov 5, 2020Appropriate Device Problem Term/Code Not Available; Migration; Appropriate Device Problem Term/Code Not Available; Migration

  BOSTON SCIENTIFIC CORPORATION RECEIVED SIX COMPLAINTS REGARDING SIX SEPARATE ADVANIX BILIARY STENT DEVICES INVOLVED IN SEPARATE PROCEDURES ON DIFFERENT PATIENTS. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SIX ADVANIX BILIARY STENTS WERE USED DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES PERFORMED IN THE COMMON BILE DUCT OF SIX DIFFERENT PATIENTS. THE SIX PROCEDURES WERE PERFORMED ON BETWEEN AUGUST 1, 2020 TO AUGUST 30, 2020. HOWEVER, THE EXACT IMPLANT DATES WERE NOT REPORTED. THE SIX PATIENTS UNDERWENT PLANNED STENT REMOVAL PROCEDURES PERFORMED BETWEEN SEPTEMBER 15, 2020 AND OCTOBER 11, 2020. THE EXACT PROCEDURE DATES WERE NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING THE PLANNED STENT REMOVAL PROCEDURES, THE PHYSICIAN FOUND THAT A DOUBLE PIGTAIL STENT HAD MIGRATED PROXIMALLY IN THE DUODENUM FOR EACH CASE. THE DEVICES WERE REMOVED AND THE PROCEDURES WERE CANCELLED/RESCHEDULED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. EACH PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10791155 ↗
• MalfunctionJan 5, 2017Kinked; Kinked

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX¿ BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE COMMON BILE DUCT ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE ADVANIX¿ BILIARY STENT KINKED WHILE INSERTING IT IN TO COMMON BILE DUCT. THE PHYSICIAN WAS UNABLE TO PLACE THE STENT IN THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX¿ BILIARY STENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6227061 ↗
• MalfunctionNov 16, 2016Kinked; Kinked

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX" BILIARY DOUBLE PIGTAIL STENT WAS USED IN THE BILE DUCT DURING A BILE DUCT STENTING PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS OBSERVED THAT THE PULL WIRE WAS DIFFICULT TO RETRACT WHEN PULLED FORCEFULLY. FURTHERMORE, IT WAS NOTICED ON THE ENDOSCOPE SCREEN THAT THE PAPILLA SIDE OF THE STENT WAS WRINKLED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6106964 ↗