Advanix™ Pancreatic Stent M00537330Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729856924), received between Sep 12, 2017 and May 7, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED INTO THE BILE DUCT TO TREAT AN OBSTRUCTION CAUSED BY STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON (B)(6) 2026. PRIOR TO PROCEDURE AND UPON OPENING THE DEVICE PACKAGE, IT WAS OBSERVED THAT THERE WAS A TEAR IN THE STENT. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25108650 ↗
• InjuryJun 20, 2024Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED IN THE PANCREATIC DUCT FOR DRAINAGE DURING AN ENDOSCOPIC RETROGRADE PANCREATIC DRAINAGE (ERPD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS DEPLOYED; HOWEVER, IT WAS NOTED THAT THE DISTAL TIP WAS KINKED. THE STENT WAS REMOVED, AND ANOTHER ADVANIX PANCREATIC 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 19578280 ↗
• MalfunctionMar 23, 2022Positioning Failure; Defective Device; Positioning Failure; Defective Device

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR. REPORT # 3005099803-2022-00628). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING A PANCREATIC DUCT STENT PLACEMENT PROCEDURE IN THE PANCREAS, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE STENT FAILED TO DEPLOY AND COULD NOT BE REMOVED FROM THE TORN GUIDE CATHETER. ANOTHER ADVANIX PANCREATIC STENT WAS OPENED AND SUCCESSFULLY COMPETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF STENT DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13869290 ↗
• MalfunctionJun 11, 2020Migration; Migration

  IT WAS REPORTED THAT AN ADVANIX PANCREATIC STENT WAS EXPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED IN THE COMMON BILE DUCT/HEPATIC DUCT PERFORMED ON (B)(6) 2020. ON (B)(6) 2020, THE ADVANIX PANCREATIC STENT WAS SUCCESSFULLY IMPLANTED WITH NO ISSUES REPORTED. ON (B)(6) 2020 DURING A PLANNED STENT REMOVAL PROCEDURE, IT WAS NOTED THAT THE ADVANIX PANCREATIC STENT HAD MIGRATED PROXIMALLY INTO THE LIVER DUCTS. AFTER REMOVING THE MIGRATED STENT, A SMALL AMOUNT OF BLOODY BILE WAS NOTED UPON REMOVAL. NO TREATMENT WAS REQUIRED FOR THE BLEED AND THE BLEEDING WAS SELF LIMITING. A NEW ADVANIX PANCREATIC PIGTAIL STENT WAS PLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10144009 ↗
• MalfunctionApr 16, 2020Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT COULD NOT PASS THROUGH THE STRICTURE SITE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF A DIFFERENT 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. INVESTIGATION RESULTS REVEALED THAT THE PANCREATIC STENT WAS KINKED THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9969492 ↗
• MalfunctionMar 30, 2020Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORTAION THAT AN ADVANIX PANCREATIC STENT WAS USED IN A PROCEDURE IN THE PANCREATIC DUCT, PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINT, DURING THE PANCREATIC DUCT STENT PLACEMENT PROCEDURE, THE PIGTAIL OF THE STENT WAS KINKED. REPROTEDLY, THERE WAS NO HEALTH DAMAGE TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER ADVANIX PANCREATIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9897508 ↗
• MalfunctionSep 12, 2017Kinked; Kinked

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING PANCREATIC DUCT STENT PLACEMENT PROCEDURE PERFORMED IN THE PANCREATIC DUCT (EXACT DATE NOT REPORTED). ACCORDING TO THE COMPLAINANT, WHEN THEY ATTEMPTED TO DEPLOY THE STENT, GUIDEWIRE WAS PLACED IN THE PANCREATIC DUCT. HOWEVER, RESISTANCE WAS FELT FROM THE MIDPOINT AND IT WAS UNABLE TO ADVANCE ANY FURTHER SO THE DEVICE WAS RETRIEVED. WHEN THEY RETRIEVED THE ADVANIX PANCREATIC STENT, THE STENT TIP ON THE DISTAL SIDE WAS FOUND TO BE ¿DAMAGED¿. THE PROCEDURE WAS COMPLETED BY PLACING ANOTHER ADVANIX PANCREATIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE "GOOD".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6858805 ↗