Advanix™ Pancreatic Stent M00537280Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729856870), received between May 20, 2019 and Jan 21, 2026 — classified as 1 injury, 4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Positioning Failure; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED IN THE MAIN PANCREATIC DUCT TO TREAT A PANCREATIC CANCER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THAT DEVICE RELEASE WAS ATTEMPTED AT THE INTENDED SITE, BUT THE INNER TUBE COULD NOT BE WITHDRAWN. ANOTHER ADVANIX PANCREATIC STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED 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 AND DAMAGED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130754 ↗
• MalfunctionDec 5, 2019Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY WITH PANCREATIC STENT IMPLANTATION PERFORMED IN THE PANCREATIC DUCT ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT KINKED ON THE PUSH CATHETER, ALTHOUGH IT HAD BEEN MOISTENED. THE STENT WAS PIERCED AT THE SITE OF THE BEND, MAKING IT UNUSABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9419040 ↗
• MalfunctionOct 14, 2019Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE PANCREATIC DUCT, PERFORMED ON (B)(6), 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, IT WAS NOTICED THAT THE STENT BUCKLED ABOUT HALF WAY UP. THE STENT WAS REMOVED OUT FROM THE PATIENT AND ANOTHER ADVANIX PANCREATIC STENT SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WAS NO SERIOUS INJURY, NOR WERE THERE ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9187076 ↗
• MalfunctionOct 8, 2019Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN THE PANCREAS PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, DIFFICULTY REMOVING THE DELIVERY SYSTEM WAS ENCOUNTERED DUE TO THE ADHESION BETWEEN THE STENT AND THE CARRIER. THE NURSE HAD TO APPLY FORCE TO REMOVE THE CARRIER, RESULTING THE STENT AND THE CARRIER TO BE KINKED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX PANCREATIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS GOOD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9167119 ↗
• InjuryMay 20, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE PANCREAS, PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE STENT PLACEMENT PROCEDURE, THE DELIVERY SYSTEM WAS UNABLE TO DEPLOY THE STENT. AFTER TRYING TO REMOVE THE DELIVERY SYSTEM FROM THE PATIENT, THE PUSH CATHETER TWISTED SO THAT THE STENT WAS UNABLE TO BE DISCONNECTED. AFTER THAT, THE STENT WAS BROKEN INTO TWO PIECES. THE BROKEN PIECES OF STENT WERE RETRIEVED WITH THE USE OF A SNARE AND THE PROCEDURE WAS SUCCESSFULLY 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 8625478 ↗