Advanix™ Pancreatic Stent Kit M00537560Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729856337), received between Jul 14, 2017 and Apr 25, 2025 — classified as 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED IN THE PANCREATIC DUCT DURING A PANCREATIC DUCT STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE LUMEN OF THE STENT COLLAPSED. 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 21914633 ↗
• MalfunctionMar 19, 2025Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ADVANIX PANCREATIC STENT WAS IMPLANTED TO TREAT A PANCREATITIS IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC PANCREATIC DUCT STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE WAS INSERTED THROUGH THE ENDOSCOPE FORCEPS CHANNEL OVER A GUIDE WIRE. UNDER ENDOSCOPIC MONITORING, A KINK (DENT) WAS OBSERVED IN THE STENT THAT EMERGED FROM THE ENDOSCOPE TIP, AND ITS USE WAS DISCONTINUED. ANOTHER ADVANIX PANCREATIC STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. 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."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21646879 ↗
• MalfunctionMar 24, 2022Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING A PROCEDURE IN THE PANCREAS, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE PHYSICIAN OPENED THAT PACKAGE, IT WAS NOTED THAT THE STENT HAD A SLIGHT BENT. WHEN THE PHYSICIAN INSERTED THE PUSHER, IT COULD NOT BE INSERTED EASILY AND WHEN IT WAS REMOVED FROM THE PATIENT, THE BENT BECAME MORE NOTICEABLE. ANOTHER ADVANIX PANCREATIC STENT OF A DIFFERENT SIZE WAS OPENED AND 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 13894808 ↗
• MalfunctionJul 15, 2020Unsealed Device Packaging; Adverse Event Without Identified Device or Use Problem; Unsealed Device Packaging; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS GOING TO BE USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THE STENT WAS PROTRUDING FROM THE PLASTIC CASE AND THE STERILITY OF THE DEVICE WAS COMPROMISED. 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 10278180 ↗
• MalfunctionApr 10, 2020Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING A PANCREATIC DUCT PLACEMENT PROCEDURE IN THE PANCREATIC DUCT. THE EXACT DATE OF THE PROCEDURE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND OUTSIDE THE PATIENT, WHEN THE PHYSICIAN ATTEMPTED TO INSERT THE ADVANIX PANCREATIC STENT, IT WAS NOTICED THAT THE STENT WAS KINKED. ANOTHER ADVANIX PANCREATIC STENT WAS OPENED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9948374 ↗
• MalfunctionJul 14, 2017Device Packaging Compromised; Device Packaging Compromised

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX¿ PANCREATIC STENT WAS USED DURING A PROCEDURE PERFORMED ON JUNE 20, 2017. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS OBSERVED THAT THE ¿UP SIDE OF STERILIZATION POUCH WAS OPENED¿ AND ¿THE STENT WAS NOT INCLUDED IN THE STERILE PACKAGE¿. THE REPRESENTATIVE DEALER NOTICED THE ISSUE WHEN HE/SHE UNPACKED THE SHIPPING BOX. THE PROCEDURE WAS COMPLETED 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 6715689 ↗