Advanix™ Pancreatic Stent M00536520Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729857464), received between Dec 19, 2016 and Jun 24, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2025Difficult to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem

  THIS REPORT PERTAINS TO ONE OF TWO ADVANIX PANCRETAIC STENTS USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT AND 3005099803-2025-02866 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ADVANIX PANCREATIC STENTS WERE TO BE IMPLANTED IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC PANCREATIC DUCT STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE FIRST ADVANIX PANCREATIC STENT (SUBJECT OF THIS REPORT) WAS ATTEMPTED TO BE PLACED. HOWEVER, THE STENT WAS UNABLE TO CROSS THE STENOSIS. IT WAS NOTED THAT THERE WAS A BUMP BETWEEN THE GUIDE CATHETER AND THE STENT DEVICE. A SECOND ADVANIX PANCREATIC STENT (SUBJECT OF MANUFACTURER REPORT # 3005099803-2025-02866) WAS ATTEMPTED TO BE PLACED, BUT THE SAME THING HAPPENED. ANOTHER OF THE SAME DEVICE 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 22321065 ↗
• MalfunctionJun 24, 2025Difficult to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem

  THIS REPORT PERTAINS TO ONE OF TWO ADVANIX PANCRETAIC STENTS USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2025-02867 AND 3005099803-2025-02866 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ADVANIX PANCREATIC STENTS WERE TO BE IMPLANTED IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC PANCREATIC DUCT STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE FIRST ADVANIX PANCREATIC STENT (SUBJECT OF MANUFACTURER REPORT # 3005099803-2025-02867) WAS ATTEMPTED TO BE PLACED. HOWEVER, THE STENT WAS UNABLE TO CROSS THE STENOSIS. IT WAS NOTED THAT THERE WAS A BUMP BETWEEN THE GUIDE CATHETER AND THE STENT DEVICE. A SECOND ADVANIX PANCREATIC STENT (SUBJECT OF THIS REPORT) WAS ATTEMPTED TO BE PLACED, BUT THE SAME THING HAPPENED. ANOTHER OF THE SAME DEVICE 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 22321063 ↗
• MalfunctionMay 13, 2025Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED IN THE PANCREATIC DUCT TO TREAT CHRONIC PANCREATITIS DURING A PANCREATIC DUCT STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT KINKED WHEN IT WAS GOING THROUGH THE ENDOSCOPE. ANOTHER SAME DEVICE WAS USED AS REPLACEMENT AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010137 ↗
• MalfunctionJan 31, 2024Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED IN THE PANCREATICOBILIARY SYSTEM, SPECIFICALLY THE PANCREATIC DUCT FOR PANCREATIC DRAINAGE, IN A PATIENT WITH POOR PANCREATIC DUCT DRAINAGE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS KINKED DURING THE DEPLOYMENT PROCESS AND IT COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX PANCREATIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18619882 ↗
• MalfunctionApr 11, 2022Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC PANCREATIC DUCT STENT IMPLANTATION PROCEDURE IN THE PANCREATIC DUCT, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, SEVERE RESISTANCE WAS FELT BETWEEN THE GUIDE CATHETER AND THE STENT. THE STENT SHRANK AND WAS DEFORMED UPON DEPLOYMENT. THE STENT WAS SUCCESSFULLY IMPLANTED TO THE PATIENT AND COMPLETED THE PROCEDURE. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE STENT WAS DEFORMED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14079502 ↗
• MalfunctionOct 28, 2020Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING A PROCEDURE. THE PROCEDURE DATE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, IT WAS NOTICED THAT THE STENT WAS KINKED. THE STENT WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX PANCREATIC STENT. 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 Consequences Or Impact To Patient

  MAUDE report 10749302 ↗
• MalfunctionJun 23, 2018Kinked; Kinked

  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 (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE STENT WAS POSITIONED IN THE MAIN PANCREATIC DUCT FOR DEPLOYMENT, THE PHYSICIAN ATTEMPTED TO PULL THE PULL WIRE BUT SEVERE RESISTANCE WAS ENCOUNTERED AND THE STENT FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; STENT KINKED. PLEASE SEE RESULTS OF MANUFACTURER'S FINAL INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7632434 ↗
• MalfunctionMar 8, 2017Kinked; Material Deformation; Kinked; Material Deformation

  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 OF A PATIENT (EXACT DATE NOT REPORTED). ACCORDING TO THE COMPLAINANT, THEY ATTEMPTED TO DEPLOY THE ADVANIX PANCREATIC STENT INTO THE PANCREATIC DUCT HOWEVER WHEN ABOUT TO COMPLETE THE PROCEDURE, IT WAS NOTICED THAT THE GUIDEWIRE GOT CAUGHT IN THE STENT LUMEN AND IT WAS UNABLE TO REMOVE. IT WAS ALSO OBSERVED THAT THE STENT DISLODGED WHEN THEY ATTEMPTED TO FORCIBLY PULL THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH THE SAME 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 "NO PROBLEM." THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; STENT KINKED AND DEFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6389139 ↗
• MalfunctionDec 19, 2016Kinked; Material Deformation; Kinked; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN COMMON BILE DUCT. ACCORDING TO THE COMPLAINANT, A DILATION WAS BEING PERFORMED ON A PATIENT THAT HAS PANCREATIC DUCT STENOSIS DUE TO CHRONIC PANCREATIS. DURING THE DILATION, THE PHYSICIAN ATTEMPTED TO DEPLOY THE ADVANIX PANCREATIC STENT, HOWEVER IT WAS HARD TO RELEASE THE STENT AND WHEN THE CATHETER WAS FORCIBLY PULLED, THE STENT MISSED THE TARGET LESION. THE GUIDEWIRE WAS UNABLE TO BE INSERTED COMPLETELY BACK INTO THE PANCREAS. THE STENT WAS REMOVED FROM THE PATIENT AND WAS RELOADED ONTO THE DELIVERY SYSTEM , HOWEVER, THE PROCEDURE COULD NOT BE COMPLETED WITH THIS 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 "NO PROBLEM". THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; STENT KINKED, STENT DEFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6186467 ↗