Advanix™ Biliary M00534360Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729787457), received between Jun 19, 2018 and Apr 17, 2026 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Contamination

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY STENT WITH NAVIFLEX DELIVERY SYSTEM WAS NOTICED TO HAVE MOISTURE INSIDE THE STERILE POUCH WHEN THE PACKAGE WAS TAKEN OUT FROM THE TRANSPORTATION BOX ON (B)(6) 2026. REPORTEDLY, THE PRODUCT DID NOT SEEM TO HAVE ANY MECHANICAL DAMAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24916465 ↗
• MalfunctionMar 18, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS TO BE IMPLANTED TO TREAT CANCER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PROSTHESIS OF THE APPLICATOR OF THE ADVANIX BILIARY DEVICE BROKE. ANOTHER OF THE SAME DEVICE 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 21633993 ↗
• MalfunctionJan 28, 2025Break; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Break; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX DELIVERY SYSTEM WAS USED IN THE PAPILLA OF VATER TO TREAT STONES DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE STENT WAS INSERTED, THE GUIDE CATHETER BROKE INTO TWO PIECES. SUBSEQUENTLY, THE BROKEN GUIDE CATHETER WAS REMOVED TOGETHER WITH THE DUODENOSCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX BILIARY STENT WITH NAVIFLEX DELIVERY SYSTEM. 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 21256500 ↗
• MalfunctionMar 21, 2024Entrapment of Device; Premature Activation; Material Deformation; Entrapment of Device; Premature Activation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS TO BE IMPLANTED DURING A PROCEDURE ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT SEPARATED FROM THE HOLDER BY ITSELF AND GOT STUCK IN THE ENDOSCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF STENT DAMAGED. PLEASE SEE BLOCK H10 FOR THE FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18952015 ↗
• InjuryMar 5, 2024Break; Positioning Failure; Entrapment of Device; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Break; 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 AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS TO BE USED FOR DRAINAGE IN THE HILAR REGION OF THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2024. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED, AND THE GUIDE CATHETER BROKE FROM THE DELIVERY SYSTEM AND DETACHED WITH THE STENT INSIDE THE PATIENT. THE BROKEN GUIDE CATHETER AND STENT WERE REMOVED USING AN ADDITIONAL DEVICE. THE ENDOSCOPE WAS THEN REMOVED TO RETRIEVE THE DELIVERY SYSTEM AND STENT TRAPPED IN THE TIP OF THE ENDOSCOPE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM. 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 CANNOT BE FULLY DEPLOYED." THE PHYSICIAN DID NOT FOLLOW THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839769 ↗
• InjuryFeb 3, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT. THE PROCEDURE WAS PERFORMED TO TREAT A BILIARY STRICTURE IN THE BILIARY SYSTEM ON (B)(6) 2023. DURING THE PROCEDURE, WHEN THE PHYSICIAN PULLED THE PULL WIRE TO DEPLOY THE STENT, THE GUIDE CATHETER BROKE WHILE STILL THROUGH THE INNER DIAMETER OF THE STENT. THE BROKEN PIECE OF GUIDE CATHETER WAS REMOVED WITH A RETRIEVAL DEVICE AND ANOTHER ADVANIX BILIARY STENT WAS USED TO SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16295381 ↗
• InjuryDec 21, 2021Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING A STENT PLACEMENT PROCEDURE IN THE INTRAHEPATIC STONE, PERFORMED ON AN UNKNOWN DATE. DURING A ROUTINE FOLLOW UP, IT WAS NOTICED THAT THE STENT MIGRATED DISTALLY INTO THE DOUDENUM. A SMALL PERFORATION OCCURED IN THE DOUDENUM AS A RESULT OF MIGRATION. CLIPS WERE USED TO SUCCESSFULLY SEAL THE PERFORATION. IT WAS UNKNOWN IF A NEW STENT WAS IMPLANTED TO THE PATIENT. THERE WERE NO OTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE AND IS EXPECTED TO FULLY RECOVER. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Perforation

  MAUDE report 13050402 ↗
• MalfunctionAug 4, 2020Material Deformation; Material Deformation

  THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2020-02322, MFR. REPORT # 3005099803-2020-02327 AND MFR. REPORT # ). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE STENT WOULD NOT PASS DEEP ENOUGH INTO THE BILE DUCT. ANOTHER ADVANIX BILIARY STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. 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 FINE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; STENT DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10361190 ↗
• MalfunctionAug 8, 2019Break; Obstruction of Flow; Break; Obstruction of Flow

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING A PROCEDURE. THE EXACT EVENT DATE WAS NOT PROVIDED. ACCORDING TO THE COMPLAINANT, DURING THE ATTEMPT TO RELEASE THE STENT, THE DELIVERY SYSTEM BREAKS, LEADING TO A BLOCKAGE OF THE CARRIER CATHETER IN THE STENT, RESULTING IN OBSTRUCTION OF THE STENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. **ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019** THE RENDEZVOUS PROCEDURE WAS PERFORMED ON (B)(6), 2019 IN THE COMMON BILE DUCT (CBD). THE PROCEDURE WAS COMPLETED AFTER THEY REMOVED THE ADVANIX BILIARY STENT AND THE PATIENT WAS IN GOOD CONDITION. NO FURTHER ISSUES WERE REPORTED WITH THE DEVICE. ADDITIONALLY, IT WAS NOTED THAT DUE TO THE DUODENAL STRICTURE, IT WAS IMPOSSIBLE TO PERFORM A CLASSIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). THEREFORE, THE PHYSICIAN PUT THE GUIDEWIRE PERCUTANEOUS INTO THE LIVER, GOING THE OPPOSITE DIRECTION IN THE BILE DUCT TO SPRING THROUGH THE PAPILLA AND THEN BACK INTO THE STOMACH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8875883 ↗
• InjuryJun 19, 2018Break; 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) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT COULD NOT BE FULLY DEPLOYED. THE PHYSICIAN NOTICED THE GUIDE CATHETER WAS STILL STUCK INSIDE THE STENT. WHEN HE TRIED TO PULL THE PULL WIRE HARDER, THE GUIDE CATHETER BROKE. THE DELIVERY SYSTEM WAS COMPLETELY PULLED OUT FROM THE PATIENT AND IT WAS NOTICED UNDER FLUOROSCOPY THAT A PART OF THE BROKEN GUIDE CATHETER REMAINED STUCK INSIDE THE STENT. THE PIECE OF BROKEN GUIDE CATHETER WAS RETRIEVED USING A GRASPING FORCEPS AND THE PROCEDURE WAS SUCCESSFULLY 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7616147 ↗