Advanix™ Biliary M00533000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729786917), received between Dec 6, 2017 and Sep 29, 2026 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration” (4 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.

• InjurySep 29, 2026Use of Device Problem; Material Deformation; Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940787 ↗
• InjuryMar 28, 2024Device-Device Incompatibility; Migration; Device-Device Incompatibility; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY DOUBLE PIGTAIL STENT WAS IMPLANTED IN THE COMMON BILE DUCT TO TREAT A PANCREATIC HEAD MASS STRICTURE SECONDARY TO PANCREATIC CANCER DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING A PLANNED STENT REMOVAL PROCEDURE ON (B)(6) 2024, THE ADVANIX STENT MIGRATED PROXIMALLY INTO THE COMMON BILE DUCT, AND A SPYBASKET WAS USED TO RETRIEVE IT. THE BASKET WAS ABLE TO GO AROUND THE DISTAL FLANGE ON THE STENT BUT WAS UNABLE TO PULL IT OUT OF THE DUCT. WHILE THE PHYSICIAN WAS PULLING, THE WIRES OF THE BASKET BROKE AND WRAPPED AROUND THE ELEVATOR ON THE SCOPE. THE STENT WAS STUCK IN THE COMMON BILE DUCT, THE BASKET BECAME STUCK ON THE STENT, AND THE SCOPE WAS STUCK TO THE BASKET. THE PATIENT ENDED UP BEING SENT TO SURGERY TO HAVE THE STENT REMOVED AND TO CUT THE SCOPE FREE FROM THE STENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD DAYS OF CARE; HOWEVER, THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18992154 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT AND SAME PATIENT ( MFR. REPORT #3005099803-2023-04471). IT WAS REPORTED TO BOSTON SCIENTIFIC THAT TWO ADVANIX BILIARY STENTS WERE SUCCESSFULLY PLACED AS STENT EXCHANGE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2023. FROM (B)(6) 2023, TO (B)(6) 2023, AT AN OUTSIDE HOSPITAL (OSH), THE PATIENT EXPERIENCED ACUTE RIGHT UPPER QUADRANT (RUQ) PAIN, EMESIS (VOMITING), CHILLS AND FEVER OF 100.7 DEGREES, CONCERNING FOR CHOLANGITIS. THE PATIENT WAS HOSPITALIZED AND WAS GIVEN LEVOFLOXACIN, METRONIDAZOLE, FLAGYL, DAPTO, AND TYLENOL AS A TREATMENT FOR CHOLANGITIS, FEVER, AND PAIN; AND WAS ALSO ADMINISTERED WITH INTRAVENOUS LACTATED RINGER'S (LR) SOLUTION FOR HYDRATION. FROM APRIL 05 TO APRIL 08, 2023, IT WAS REPORTED THAT THE CHOLANGITIS WAS GROWING AND WAS VANCOMYCIN-RESISTANT ENTEROCOCCI COMPLICATED BY SEPSIS, AND POST ERCP PANCREATITIS WITH HEPATIC ABSCESS DUE TO THE PROCEDURE PERFORMED ON (B)(6) 2023. FROM (B)(6) 2023 TO (B)(6) 2023, THE PATIENT EXPERIENCED ABDOMINAL PAIN IN THE SETTING OF TRANSAMINITIS WITH OBSTRUCTION. THE PATIENT WAS DISCHAR

  Patient problems: Abscess; Cholangitis; Fever; Pain; Sepsis; Vomiting

  MAUDE report 17612906 ↗
• InjuryJun 5, 2023Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX BILIARY STENT WAS IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE BILE DUCT/DUODENUM, PERFORMED ON (B)(6) 2023. POST PROCEDURE, DURING A FOLLOW UP VISIT (B)(6) 2023, THE PATIENT REPORTED DISCOMFORT. THE PHYSICIAN CONDUCTED AN ERCP PROCEDURE AND FOUND OUT THAT THE DISTAL FLANGE OF THE STENT WAS EMBEDDED INTO THE DUODENAL WALL. A SNARE DEVICE WAS SUCCESSFULLY USED TO REPOSITION THE STENT FROM THE DUODENAL WALL AND THE PROCEDURE WAS COMPLETED. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO HAVE FULLY RECOVERED.

  Patient problems: Discomfort; Perforation

  MAUDE report 17064553 ↗
• MalfunctionMar 4, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE EVENT DATE WAS NOT REPORTED. IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS FOUND THAT THE STENT "FLANGE" WAS TORN OFF AND BROKEN INTO TWO PIECES. 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 11409025 ↗
• InjuryJun 25, 2019Migration; Migration

  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 ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, WHEN THE PATIENT RETURNED FOR A ROUTINE SCAN ON (B)(6) 2019, IT WAS NOTICED THAT THE STENT HAD MIGRATED PROXIMALLY INTO THE COMMON BILE DUCT. ON (B)(6) 2019, A SCHEDULED STENT REMOVAL WAS PERFORMED AND THE STENT WAS RETRIEVED WITH THE USE OF SPY RETRIEVAL SNARE. A WALLFLEX 10X60 STENT WAS IMPLANTED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SERIOUS INJURY, NOR WERE THERE ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8732288 ↗
• MalfunctionDec 6, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREVIOUSLY IMPLANTED ADVANIX¿ BILIARY STENT WAS REMOVED FROM A PATIENT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE COMMON BILE DUCT. THE EXACT IMPLANT AND EXPLANT DATES WAS NOT REPORTED, HOWEVER, THE REMOVAL PROCEDURE OCCURRED WITHIN A MONTH OF STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PLANNED STENT REMOVAL PROCEDURE, IT WAS NOTED THAT THE ADVANIX¿ BILIARY STENT EXPERIENCED A PROXIMAL MIGRATION. THE STENT WAS REMOVED WITH THE USE OF FORCEPS OR A SNARE. 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 7089064 ↗
• InjuryDec 6, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREVIOUSLY IMPLANTED ADVANIX¿ BILIARY STENT WAS ATTEMPTED TO BE REMOVED FROM A PATIENT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE COMMON BILE DUCT. THE EXACT IMPLANT AND EXPLANT DATES WAS NOT REPORTED, HOWEVER, THE REMOVAL PROCEDURE OCCURRED WITHIN A MONTH OF STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PLANNED STENT REMOVAL PROCEDURE, IT WAS NOTED THAT THE ADVANIX¿ BILIARY STENT EXPERIENCED A PROXIMAL MIGRATION. THE STENT WAS NOT REMOVED AND THE PATIENT IS SCHEDULED TO RETURN FOR A SECONDARY PROCEDURE IN ORDER TO REMOVE THE MIGRATED ADVANIX 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".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7089057 ↗
• MalfunctionDec 6, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREVIOUSLY IMPLANTED ADVANIX¿ BILIARY STENT WAS REMOVED FROM A PATIENT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE COMMON BILE DUCT. THE EXACT IMPLANT AND EXPLANT DATES WAS NOT REPORTED, HOWEVER, THE REMOVAL PROCEDURE OCCURRED WITHIN A MONTH OF STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PLANNED STENT REMOVAL PROCEDURE, IT WAS NOTED THAT THE ADVANIX¿ BILIARY STENT EXPERIENCED A PROXIMAL MIGRATION. THE STENT WAS REMOVED WITH THE USE OF FORCEPS OR A SNARE. 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 7089056 ↗