Advanix™ Biliary M00534290Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08714729787389), received between Jul 5, 2017 and Sep 8, 2026 — classified as 4 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Activation, Positioning or Separation Problem; Positioning Problem

  It was reported to Boston Scientific Corporation that an Advanix-NaviFlex RX Biliary Stent was to be implanted in the common bile duct to treat a biliary obstruction during an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure performed on (b)(6) 2026. During deployment of a plastic biliary stent into the left hepatic system, the stent was advanced and positioned as intended. The delivery system pullwire was retracted completely until the hard stop was reached, and the stent was able to be fully deployed. The guidewire was then subsequently removed. However, the suture loop did not release from the delivery system and became wrapped around the stent flange. As the delivery system was withdrawn, the attached suture loop pulled the stent out of the duct. Troubleshooting was performed to free the retained suture loop. Initial attempts to cut the suture using forceps were unsuccessful. A SpyBite device was then used to successfully cut the suture loop, releasing the stent from the delivery system. Following release, a rat-tooth forceps was used in an attempt to reposition the stent back into the duct; however, repositioning was unsuccessful. The stent was subsequently remo

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50673194 ↗
• MalfunctionNov 25, 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 AN ADVANIX BILIARY STENT WAS IMPLANTED TO THE COMMON BILE DUCT TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT DID NOT HAVE A TORTUROUS ANATOMY. DURING A STENT DEPLOYMENT PROCEDURE, THE STENT WAS INITIALLY PLACED IN THE CORRECT ANATOMICAL LOCATION, AND THE GUIDEWIRE WAS SUCCESSFULLY REMOVED. HOWEVER, UPON DEPLOYING THE STENT, THE INNER WIRE OF THE CATHETER UNEXPECTEDLY DETACHED FROM THE DELIVERY SYSTEM. THIS RESULTED IN THE INNER WIRE BECOMING STUCK WITHIN THE DELIVERY SYSTEM WHILE STILL INSIDE THE PATIENT. TO RESOLVE THE ISSUE, THE PHYSICIAN MANUALLY PULLED THE INNER WIRE, WHICH INADVERTENTLY CAUSED THE STENT TO SHEAR FROM THE DISTAL FLANGE TO THE END. DESPITE THIS MECHANICAL FAILURE, THE STENT REMAINED IN ITS INTENDED POSITION, AND NO DISPLACEMENT OCCURRED. WHEN THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT, THE BROKEN GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER ENABLING FOR THE DELIVERY SYSTEM TO BE REMOVED IN ONE PIECE. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23648834 ↗
• InjuryNov 12, 2025Migration; Migration

  IT WAS REPORTED TO (B)(4) CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX DELIVERY SYSTEM WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. POST-PROCEDURE DURING AN EMERGENT FOLLOW-UP, IT WAS NOTICED THAT THE ADVANIX STENT MIGRATED DISTALLY AND CAUSED A PERFORATION ON THE OPPOSING DUODENAL WALL. REPORTEDLY, THE STENT WAS REMOVED. THE PATIENT CONDITION AFTER REMOVAL WAS NOT REPORTED.

  Patient problems: Perforation

  MAUDE report 23536461 ↗
• MalfunctionJul 11, 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 AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS TO BE IMPLANTED TO TREAT A BILIARY OBSTRUCTION IN THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, TIP OF THE GUIDE CATHETER WAS FRACTURED; HOWEVER THE DEVICE HAD NOT BEEN DELIVERED INTO THE PATIENT. ANOTHER ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS USED TO COMPLETE 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22486891 ↗
• InjuryJul 10, 2025Break; Positioning Failure; Adverse Event Without Identified Device or Use Problem; Break; Positioning Failure; 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 BILIARY TRACT TO TREAT BILIARY OBSTRUCTION DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CONNECTION OF THE ADVANCER AND THE STENT WAS FRACTURED, AND THE STENT COULD NOT BE DEPLOYED, AND THE BROKEN GUIDE CATHETER WAS REMOVED USING SNARES. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS DUE TO THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22471974 ↗
• MalfunctionJul 10, 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-NAVIFLEX BILIARY STENT WAS TO BE IMPLANTED IN THE BILE DUCT TO TREAT A BILE DUCT STENOSIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BLACK INNER CORE OF THE STENT COULD NOT MOVE ALONG THE OPERATING WIRE, PREVENTING THE DEVICE FROM REACHING THE TARGET POSITION. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT REMAINED STABLE POST-PROCEDURE. NOTE: IT WAS REPORTED THAT THE BARB FLAP COVER WAS NOT USED TO INSERT THE DEVICE THROUGH THE BIOPSY CAP. PER THE IFU, "SLIDE THE OUTER ORANGE SLEEVE OVER THE MOST PROXIMAL STENT BARB TO HOLD IT DOWN FOR STENT INSERTION." IN ADDITION, IT WAS REPORTED THAT THE GUIDEWIRE WAS INSIDE THE PATIENT DURING THE ATTEMPTED DEPLOYMENT. HOWEVER, THE ADVANIX-NAVIFLEX BILIARY STENT INSTRUCTIONS FOR USE (IFU) STATES, "TO DEPLOY THE STENT, LOOSEN THE TUOHY-BORST ADAPTER SLIGHTLY AND PULL ON THE GUIDE CATHETER LUER-LOK HUB AND GUIDEWIRE. HOLD THE OUTER POSITIONER STATIONARY, WHILE GENTLY RETRACTING THE INNER GUIDE CATHETE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22469953 ↗
• MalfunctionJul 8, 2025Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS TO BE IMPLANTED TO TREAT A STONE IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THEY CAREFULLY PUSHED THE STENT INTO THE BILE DUCT, AIMING TO RELEASE IT. AFTER REMOVING THE GUIDE WIRE, THEY NOTICED THE STEEL STYLET WAS SURPRISINGLY EASY TO PULL BACK. HOWEVER, THE BLACK CATHETER, WHICH HELD THE STENT, DID NOT RETRACT ALONG WITH IT, PREVENTING THE STENT FROM BEING RELEASED. IT APPEARED THAT THE STEEL STYLET HAD DISCONNECTED FROM THE BLACK CATHETER. ANOTHER ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM 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 22433138 ↗
• MalfunctionJul 8, 2025Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS TO BE IMPLANTED TO TREAT A STONE IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2025. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THEY CAREFULLY PUSHED THE STENT INTO THE BILE DUCT, AIMING TO RELEASE IT. AFTER REMOVING THE GUIDE WIRE, THEY NOTICED THE STEEL STYLET WAS SURPRISINGLY EASY TO PULL BACK. HOWEVER, THE BLACK CATHETER, WHICH HELD THE STENT, DID NOT RETRACT ALONG WITH IT, PREVENTING THE STENT FROM BEING RELEASED. IT APPEARED THAT THE STEEL STYLET HAD DISCONNECTED FROM THE BLACK CATHETER. ANOTHER ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM 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 22433133 ↗
• MalfunctionJun 11, 2025Break; Positioning Failure; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Break; Positioning Failure; Activation, Positioning or Separation 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 IMPLANTED IN THE BILE DUCT TO TREAT A BILE STASIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2025. DURING PROCEDURE, THE ADVANIX BILIARY STENT COULD NOT BE DEPLOYED AS THE NAVIFLEX INSERTION SET DID NOT UNRAVEL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 22188553 ↗
• MalfunctionApr 1, 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 AN ADVANIX BILIARY STENT WITH NAVIFLEX DELIVERY SYSTEM WAS TO BE USED TO TREAT OBSTRUCTIVE JAUNDICE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, OUTSIDE THE PATIENT, THE HANDLE WAS PULLED BACK TO ADJUST THE LENGTH OF THE BLACK INNER CORE AT THE FRONT END. HOWEVER, THE STEEL-WIRE-GUIDED INNER CORE FRACTURED, PREVENTING THE BLACK INNER CORE FROM BEING ADJUSTED. ANOTHER ADVANIX BILIARY STENT WITH NAVIFLEX DELIVERY SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS RELATED TO 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 GUIDE CATHETER WAS BENT AND DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21740911 ↗
• InjuryMar 28, 2024Break; Use of Device Problem; Material Deformation; Break; Use of Device Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX DELIVERY SYSTEM WAS TO BE USED IN THE COMMON BILE DUCT TO TREAT A STRICTURE SECONDARY TO CHOLANGIOCARCINOMA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TIGHT AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE GUIDE CATHETER BROKE FROM THE PUSH CATHETER AND WAS LEFT IN THE COMMON BILE DUCT. THE BROKEN GUIDE CATHETER WAS REMOVED FROM THE PATIENT USING GRASPERS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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. IT WAS REPORTED THAT THE BARB FLAP COVER WAS NOT USED TO INSERT THE DEVICE THROUGH THE BIOPSY CAP. HOWEVER, THE ADVANIX B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18998197 ↗
• InjuryAug 8, 2023Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX BILIARY STENT WAS USED FOR STENT PLACEMENT DURING A PROCEDURE ON (B)(6) 2023. AT AN UNKNOWN DATE, IT WAS FOUND THAT THE STENT FELL OUT AND PERFORATED THE DUODENUM. IT WAS REPORTED THAT THE MIGRATED STENT WAS REMOVED FROM THE PATIENT. IT IS UNKNOWN IF A NEW STENT WAS IMPLANTED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION, INCLUDING PATIENT OUTCOME, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Perforation

  MAUDE report 17479808 ↗
• MalfunctionMar 14, 2022Break; Positioning Failure; Entrapment of Device; Break; Positioning Failure; Entrapment of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH A STENT PLACEMENT PROCEDURE IN THE COMMON BILE DUCT. THE EVENT DATE WAS NOT PROVIDED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE ADVANIX BILIARY STENT DID NOT DEPLOY CORRECTLY. ALSO, IT WAS FOUND THAT THE INNER GUIDE CATHETER WOULD NOT FUNCTION; IT WAS STUCK IN THE ELEVATOR AND BROKE UPON ATTEMPTED DEPLOYMENT. 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 FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13758530 ↗
• MalfunctionOct 19, 2021Break; Premature Activation; Use of Device Problem; Material Deformation; Material Split, Cut or Torn; Break; Premature Activation; Use of Device Problem; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CALCULUS REMOVAL PROCEDURE IN THEGALL BLADDER PERFORMED ON (B)(6) 2021. DURING PREPARATION, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE STENT DEPLOYED PREMATURELY AND FELL OFF BY ITSELF. 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 STABLE. INVESTIGATION RESULTS REVEALED THAT THE STENT BARB WAS TORN, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657926 ↗
• MalfunctionJul 22, 2021Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE INTESTINE PERFORMED ON (B)(6), 2021. AN 85 YEARS OLD, MALE, WHO HAD AN OBSTRUCTION OF BILIARY TRACT UNDERGONE PLASTIC STENTING FOR DRAINAGE. DURING PROCEDURE, WHEN THE STENT WAS SUCCESSFULLY IMPLANTED, IT WAS NOTED THAT THEY HAD DIFFICULTY REMOVING THE DELIVERY SYSTEM. IT WAS REPORTED THAT THEY HAVE TRIED SEVERAL TIMES BUT THE STENT COULD NOT BE DEPLOYED. 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 GUIDE CATHETER WAS BROKEN THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12214183 ↗
• MalfunctionJul 5, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ADVANIX¿ BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(4) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE ADVANIX¿ BILIARY STENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH THE SAME 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 'STABLE'.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6687415 ↗