Advanix™ Biliary M00534270Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729787365), received between Dec 30, 2016 and Feb 13, 2026 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Break; Use of Device Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIIARY PRELOADED STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT TIGHT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE STENT WOULD NOT DEPLOY CORRECTLY AS THE SUTURE DID NOT FULLY RELEASE. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE GUIDEWIRE WAS INSIDE THE PATIENT DURING THE ATTEMPTED DEPLOYMENT. HOWEVER, THE ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: "FOR PRELOADED SYSTEM ONLY: IF THE GUIDEWIRE IS NOT COMPLETELY RETRACTED INTO THE ENDOSCOPE, THE STENT CAN NOT BE FULLY DEPLOYED." NOTE: IT WAS REPORTED THAT THE BARB FLAP COVER WAS NOT USED TO INSERT THE DEVICE THROUGH THE BIOPSY CAP. HOWEVER, THE ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: "SLIDE THE STENT BARB COVER OVER THE TRAILING BARB TO ASSIST WITH STENT INTRODUCTION INTO THE SCOPE." NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333553 ↗
• MalfunctionFeb 11, 2026Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED TO TREAT STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN ATTEMPTING TO DEPLOY THE STENT, THE NURSE RETRACTED THE STYLET FULLY UNTIL THE GREEN MARKER WAS VISIBLE. THE PHYSICIAN THEN PULLED THE PULLLWIRE; HOWEVER, THE STENT DID NOT DEPLOY. IT WAS NOTED THAT THE BLACK INTRODUCER DID NOT MOVE, SUGGESTING THAT THE METAL STYLET MAY HAVE DETACHED INTERNALLY OR OTHERWISE PREVENTED THE INTRODUCER FROM RETRACTING. AS A RESULT, THE ENTIRE SCOPE HAD TO BE REMOVED BECAUSE DEPLOYMENT COULD NOT BE ACHIEVED. A SECOND ADVANIX NAVIFLEX BILIARY STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317361 ↗
• MalfunctionFeb 2, 2026

  BILIARY STENT FAILED TO RELEASE DURING PTS ERCP [ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY]. HAD TO REMOVE FAULTY EQUIPMENT FROM PT'S BILIARY DUCT AND THEN RE-CANNULATE TO PLACE ANOTHER STENT. SECOND STENT DEPLOYED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24229059 ↗
• InjurySep 16, 2025Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS IMPLANTED IN THE COMMON BILE DUCT TO TREAT AN OBSTRUCTION CAUSED BY BILE DUCT STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. FOUR WEEKS AFTER THE PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH PAIN AND DISCOMFORT. THE PHYSICIAN CONDUCTED AN ENDOSCOPIC PROCEDURE AND FOUND THAT THE IMPLANTED ADVANIX BILIARY STENT HAD MIGRATED AND PERFORATED THE LUMEN OF THE DUODENAL WALL. IT WAS OBSERVED THAT HALF OF THE STENT HAD PENETRATED THROUGH. REPORTEDLY, THE BILE DUCT STONES MEASURED APPROXIMATELY 1 CM IN SIZE. THE PHYSICIAN THEN REMOVED THE STENT USING SNARES AND CLOSED THE FISTULA USING RESOLUTION CLIPS. FOLLOWING THE STENT REMOVAL, THE PATIENT REMAINED IN THE HOSPITAL FOR ONE WEEK TO UNDERGO ANOTHER ERCP PROCEDURE TO REMOVE THE STONES, WHICH INVOLVED IMPLANTING ANOTHER ADVANIX BILIARY STENT. THE CONDITION OF THE PATIENT WAS REPORTED TO HAVE FULLY RECOVERED.

  Patient problems: Discomfort; Pain; Perforation

  MAUDE report 23069118 ↗
• InjuryMay 19, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ADVANIX-NAVIFLEX BILIARY STENT WAS TO BE IMPLANTED TO TREAT A COMMON BILE DUCT (CBD) STRICTURE IN THE PAPILLA OF THE SECOND PORTION OF THE DUODENUM DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. POST PROCEDURE, PATIENT RETURNED TO THE HOSPITAL THREE MONTHS AFTER THE BILE DUCT STENT WAS INSTALLED FOR ITS REMOVAL. IT WAS DISCOVERED THAT THE STENT HAD NOT BEEN FULLY REMOVED; A PORTION OF IT REMAINED IN THE COMMON BILE DUCT (CBD). THE REMAINING FRAGMENTS WERE SUBSEQUENTLY EXTRACTED USING BIOPSY FORCEPS. ORIGINAL DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT STATUS FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044593 ↗
• MalfunctionApr 1, 2025Positioning Failure; Entrapment of Device; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Entrapment of Device; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ADVANIX BILIARY STENT WITH NAVIFLEX DELIVERY SYSTEM WAS IMPLANTED TO TREAT A BILE DUCT STRICTURE IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE INNER CORE OF THE STEEL WIRE WAS STUCK, AND THE STENT COULD NOT BE RELEASED. ANOTHER ADVANIX-NAVIFLEX BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS, WHICH REVEALED THAT THE STENT BARB WAS TORN. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21741145 ↗
• MalfunctionOct 31, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS TO BE IMPLANTED IN THE INFERIOR BILE DUCT TO TREAT JAUNDICE WITH MALIGNANT TUMOR DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2024. DURING PREPARATION, IT WAS NOTED THAT THE CONNECTING WIRE IN THE FRONT END OF THE STENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX BILIARY STENT, THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULT WHICH REVEALED THAT THE GUIDE CATHETER WAS BROKEN. PLEASE SEE BLOCK H11 FOR THE FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20578297 ↗
• MalfunctionOct 30, 2024Break; Use of Device Problem; Difficult to Advance; Break; Use of Device Problem; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX- NAVIFLEX BILIARY RX STENT WAS TO BE IMPLANTED IN THE BILE DUCT FOR THE TREATMENT OF JAUNDICE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THERE WAS DIFFICULTY ADVANCING THE STENT AND THE SUTURE WAS BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER ADVANIX-NAVIFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE TIP OF THE GUIDE CATHETER WAS TORN. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20567953 ↗
• MalfunctionOct 21, 2024Positioning Failure; Material Split, Cut or Torn; Positioning Failure; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX STENT WITH NAVIFLEX DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE COMMON BILE DUCT FOR STONE REMOVAL DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION STENT. OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT BARB WAS TORN. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494926 ↗
• MalfunctionJun 18, 2024Positioning Failure; Retraction Problem; Material Deformation; Material Split, Cut or Torn; Positioning Failure; Retraction Problem; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ADVANIX- NAVIFLEX BILIARY RX STENT WAS TO BE IMPLANTED IN THE BILE DUCT FOR URETEROSCOPIC LITHOTRIPSY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED DESPITE PULLING THE PULL WIRE VIGOROUSLY, AND THE STENT WAS NOTED TO BE TWISTED. THE PROCEDURE WAS COMPLETED USING ANOTHER ADVANIX-NAVIFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT BARB WAS TORN. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558171 ↗
• InjuryNov 23, 2021Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS IMPANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2021. DURING A ROUTINE FOLLOW UP PROCEDURE, PERFORMED ON (B)(6) 2021, IT WAS NOTICED THAT THE STENT HAD MIGRATED PROXINALLY. THE PATIENT WAS BROUGHT BACK FOR A THIRD AND FINAL PROCEDURE FOR STENT REMOVAL FROM HILAR AREA. THE MIGRATED ADVANIX BILIARY STENT WAS SUCCESSFULLY RETRIEVED WITH AN EXTRACTOR BALLOON. THERE WAS NO NEW STENT IMPLANTED TO THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12859433 ↗
• MalfunctionDec 30, 2016Kinked; Kinked

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX¿ BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN COMMON BILE DUCT ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, WHILE THE PHYSICIAN WAS PLACING THE ADVANIX BILIARY STENT IN THE PATIENT¿S COMMON BILE DUCT, THE ENDOSCOPIC MARKER ON THE DISTAL END OF THE STENT WAS NOT VISIBLE, SO THE PHYSICIAN REMOVED THE STENT FROM THE PATIENT. UPON EXAMINATION OF THE STENT, THE PHYSICIAN REPORTED THAT THE ENDOSCOPIC MARKER APPEARED TO BE ON THE PROXIMAL END OF THE STENT AND NOT THE DISTAL END OF THE STENT. THE DEVICE WAS NOT IMPLANTED AND 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". THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; STENT KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6216019 ↗