Advanix™ Biliary M00534210Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729787303), received between Nov 15, 2016 and Dec 3, 2025 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY PRELOADED DB STENT WAS IMPLANTED IN THE DUODENUM TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BLACK INNER CATHETER BROKE INSIDE THE PATIENT. THE BROKEN GUIDE CATHETER FRAGMENT WAS REMOVED USING FORCEPS, AND THE PROCEDURE WAS COMPLETED. 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." THE PHYSICIAN DID NOT FOLLOW THE STEPS CITED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23711215 ↗
• MalfunctionJul 10, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DELIVERY SYSTEM WAS BROKEN. ANOTHER ADVANIX-NAVIFLEX RX BILIARY STENT WAS USED TO 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 22476221 ↗
• MalfunctionMay 22, 2025Positioning Failure; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Use of Device Problem; 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 AN OBSTRUCTIVE JAUNDICE IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, STENT COULD NOT BE DEPLOYED NORMALLY WHEN THE INNER CORE WAS PULLED BACK, THE STENT ADHERED TO THE SHEATH. ANOTHER ADVANIX-NAVIFLEX BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT STATUS FOLLOWING THE PROCEDURE WAS STABLE. NOTE: IT WAS REPORTED THAT THE GUIDEWIRE WAS IN THE PATIENT DURING THE ATTEMPTED DEPLOYMENT. PER THE IFU, "IF THE GUIDEWIRE IS NOT COMPLETELY RETRACTED INTO THE DELIVERY SYSTEM, THE STENT CANNOT BE FULLY DEPLOYED." THE USER DID NOT FOLLOW THE IFU; THEREFORE, THIS COMPLAINT HAS BEEN ASSIGNED AR CODE 5191: 2457 TO CAPTURE USER ERROR. THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON 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 22072520 ↗
• InjuryApr 1, 2024Break; Difficult to Remove; Positioning Problem; Break; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY AND NAVIFLEX RX DELIVERY SYSTEM WAS TO BE USED IN THE BILE DUCT TO TREAT A BILE DUCT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TIGHT. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED BEYOND THE STRICTURE IN THE CORRECT PLACE AS THE DELIVERY CATHETER BECAME DISCONNECTED. THIS RESULTED IN THE STENT TO BE PLACED IN THE WRONG POSITION. THE STENT WAS ATTEMPTED TO BE REMOVED USING GRASPING FORCEPS; HOWEVER, THE STENT FELL TO PIECES. THE BROKEN STENT WAS LEFT INSIDE THE PATIENT AS IT COULD NOT BE FULLY RETRIEVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 19015304 ↗
• InjuryMar 15, 2024Break; Difficult or Delayed Positioning; Break; Difficult or Delayed Positioning

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY PRELOADED DOUBLE PIGTAIL STENT WAS IMPLANTED IN THE DISTAL COMMON BILE DUCT TO TREAT A TIGHT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS DIFFICULT TO DEPLOY, AND THE GUIDE CATHETER WAS BROKEN. THE BROKEN GUIDE CATHETER WAS REMOVED FROM THE PATIENT USING RAT-TOOTH FORCEPS. THE STENT REMAINS IMPLANTED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18911919 ↗
• MalfunctionMar 11, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX RX BILIARY STENT WAS TO BE USED IN THE COMMON BILE DUCT TO TREAT BILIARY OBSTRUCTION DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN RETRACTED THE PULL WIRE, BUT THE GUIDE CATHETER DETACHED FROM THE PULL WIRE AND THE STENT WAS UNABLE TO BE DEPLOYED. 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 OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18876255 ↗
• MalfunctionFeb 15, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY PRELOADED DOUBLE BEND STENT WAS USED FOR BILIARY DUCT DRAINAGE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION, IT WAS NOTED THAT THE BLACK GUIDE CATHETER WAS PEELED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18717196 ↗
• MalfunctionSep 29, 2023Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX BILIARY STENT AND NAVIFLEX RX DELIVERY SYSTEM WAS SELECTED FOR USE IN THE COMMON HEPATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, THE GUIDE CATHETER COULD NOT BE WITHDRAWN, AND THE STENT COULD NOT BE DEPLOYED. THE ADVANIX BILIARY STENT AND NAVIFLEX RX DELIVERY SYSTEM WERE REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF GUIDE CATHETER BREAK. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17844620 ↗
• MalfunctionNov 4, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning

  NOTE: THIS REPORT IS ONE OF THREE COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT #3005099803-2022-06245, MFR REPORT #3005099803-2022-06268. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE ADVANIX BILIARY STENTS WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE BILE DUCT, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY PUSHING THE STENTS OUT OF THE ENDOSCOPE. THE PATIENT HAD A BILE DUCT ANOMALY AND THE PHYSICIAN DID NOT HAVE A GOOD VISION OF THE STENT GOING INTO THE BILE DUCT. A BLUE AREA WAS VISUALIZED ON THE SCREEN BUT THE PHYSICIAN COULD NOT DETERMINE IF THE FIRST STENT WAS DEPLOYED. IT APPEARED AS THOUGH A PART OF THE STENT MAY HAVE BEEN BLOCKING THE LENS VIEW. THE FIRST STENT WAS DEPLOYED PREMATURELY AND WAS THEN REMOVED FROM THE PATIENT. THERE WAS DIFFICULTY IN DEPLOYING THE SECOND STENT AS IT APPEARED LOST IN THE VIEW BUT WAS THEN SUCCESSFULLY DEPLOYED IN THE ANATOMY. THE PHYSICIAN REMOVED THE ENDOSCOPE AND THE THIRD STENT WAS SUCCESSFULLY DEPLOYED. AS A RESULT, THERE WAS AN APPROXIMATELY ONE AND A HALF HOUR SURGICAL DELAY AND THE INTENDED PROCEDURE WAS NOT COMPLETED. THE PATIENT WAS SCHEDULED T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15738159 ↗
• MalfunctionJun 25, 2022Break; Premature Activation; Difficult to Advance; Break; Premature Activation; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THERE WAS DIFFICULTY ADVANCING THE STENT INTO THE BILIARY TREE OVER THE GUIDEWIRE. THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT FROM THE PATIENT TO DILATE THE STRICTURE PRIOR TO DEPLOYMENT. WHILE THE PHYSICIAN WAS TRYING TO REMOVE THE FULL STENT DELIVERY SYSTEM, THE STENT DEPLOYED IN THE WORKING CHANNEL OF THE SCOPE. ANOTHER ADVANIX BILIARY STENT WAS OPENED AND SUCCESSFULLY COMPETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THE GUIDE CATHETER DETACHED/SEPARATED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14812532 ↗
• MalfunctionMay 26, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE, ON AN UNKNOWN DATE. ON (B)(6) 2022, A PLANNED STENT REMOVAL PROCEDURE WAS PERFORMED. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT, A PIECE OF THE STENT BROKE OFF. THE PROCEDURE WAS COMPLETED AND IT WAS UNKNOWN IF A NEW STENT HAS BEEN IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14515821 ↗
• MalfunctionOct 30, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6), 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, OUTSIDE THE PATIENT, WHEN THE PHYSICIAN ATTEMPTED TO LOAD THE STENT INTO THE SCOPE, IT WAS NOTICED THAT THE FLAP OF THE STENT WAS BROKEN. ANOTHER ADVANIX STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WAS NO SERIOUS INJURY, NOR WERE THERE ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9256339 ↗
• InjuryNov 15, 2016Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX" RX BILIARY STENT WAS ATTEMPTED TO BE REMOVED FROM A PATIENT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE COMMON BILE DUCT ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE STENT REMOVAL PROCEDURE, THE PHYSICIAN LASSOED THE ADVANIX" RX BILIARY STENT .5CM ABOVE THE FLANGE OUTSIDE OF THE PAPILLA USING THE SNARE AND THE STENT BROKEN IN HALF. THE PHYSICIAN COULD NOT RETRIEVE THE ENTIRE STENT AND THE PATIENT WAS REFERRED TO ANOTHER PROCEDURE IN ORDER TO REMOVE THE REMAINING PIECES OF STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS DOING WELL AND THE BILE DUCT WAS DRAINING PROPERLY AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6101369 ↗