Advanix™ Pancreatic Stent M00537320Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729856917), received between Oct 6, 2021 and Jun 13, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2025Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED TO TREAT PANCREATITIS DURING A PANCREATIC DUCT STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE GUIDEWIRE COULD NOT BE INSERTED INTO THE STENT. ANOTHER ADVANIX PANCREATIC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT WAS KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22206249 ↗
• MalfunctionFeb 4, 2022Material Deformation; Material Deformation

  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 PREPARATION, WHEN TRYING TO SET THE STENT IN THE INNER CATHETER, IT WAS FOUND THAT THE PIGTAIL PART OF THE STENT WAS KINKED. THE ORANGE ADAPTER WAS USED BUT THE INNER CATHETER COULD NOT BE INSERTED. ANOTHER ADVANIX PANCREATIC STENT 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 13453231 ↗
• MalfunctionOct 6, 2021Positioning Failure; Retraction Problem; Stretched; Material Deformation; Positioning Failure; Retraction Problem; Stretched; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING A PANCREATIC DUCT STENT PLACEMENT PROCEDURE IN THE PANCREATIC DUCT, PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE GUIDE CATHETER COULD NOT BE RETRACTED. WHEN THE GUIDE CATHETER WAS RELEASED ON THE HANDLE SIDE, THERE WAS NO FORCE ON THE TIP, IT DID NOT EXTEND AND COULD NOT BE RELEASED. WHEN THE GUIDE CATHETER WAS PULLED ON THE HANDLE, IT BECAME STRETCHED AND THE STENT COULD NOT BE DEPLOYED. WHEN THE STENT WAS RELEASED, IT WAS NOTICED THAT THE PIGTAIL SIDE OF THE STENT WAS DEFORMED INTO A PLEATED SHAPE. ANOTHER ADVANIX PANCREATIC STENT 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 12586901 ↗