Advanix™ Pancreatic Stent M00537300Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729856894), received between Feb 17, 2017 and Jul 8, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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.

• MalfunctionJul 8, 2025Break; Positioning Failure; Deformation Due to Compressive Stress; Material Deformation; Break; Positioning Failure; Deformation Due to Compressive Stress; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22432818 ↗
• MalfunctionMay 29, 2025Positioning Failure; Defective Device; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Defective Device; 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 PANCREATIC DUCT DURING A PANCREATIC DUCT STENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT WAS INSERTED INTO THE PANCREATIC DUCT AND DEPLOYMENT WAS ATTEMPTED. HOWEVER, THE INNER SHEATH COULD NOT BE PULLED, AND DEPLOYMENT WAS UNSUCCESSFUL. THE ADVANIX STENT WAS THEN REMOVED TOGETHER WITH THE DELIVERY SYSTEM, AND IT APPEARED THAT THE PIG TAIL PART OF THE STENT GOT LIFTED (FAILED TO CURL). THE PROCEDURE WAS THEN COMPLETED USING A NON-BOSTON SCIENTIFIC DEVICE. THERE WAS NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106872 ↗
• MalfunctionJun 13, 2023Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX PANCREATIC STENT WAS ATTEMPTED TO BE USED ON MAY 22, 2023. DURING PROCEDURE PREPARATION, OUTSIDE THE PATIENT, THE ADVANIX PANCREATIC STENT PIGTAIL KINKED WHILE CROSSING THE GUIDE WIRE. 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 REPORTED AS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17122502 ↗
• MalfunctionNov 9, 2022Device Difficult to Setup or Prepare; Material Deformation; Device Difficult to Setup or Prepare; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS TO BE USED DURING A PANCREATIC STENT PLACEMENT PROCEDURE IN THE PANCREATIC DUCT, PERFORMED ON (B)(6), 2022. DURING PREPARATION, IT WAS NOTED THAT THE STENT WAS KINKED AND COULD NOT BE MOUNTED INTO THE DELIVERY SYSTEM. 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 15761918 ↗
• MalfunctionJan 6, 2022Material Deformation; Material Deformation

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 33005099803-2021-08059). IT WAS REPORTED BOSTON SCIENTIFIC CORPORATION THAT A ADVANIX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2021. DURING PREPARATION, WHEN THE GUIDEWIRE WAS TRIED TO PUT THROUGH THE ADVANIX PANCREATIC STENT, THE STENT BECAME KINKED. IT WAS REPORTED THAT THIS HAPPENED WITH TWO ADVANIX PANCREATIC STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX PANCREATIC STENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE AS "NO PATIENT COMPLICATIONS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13175031 ↗
• MalfunctionJan 6, 2022Material Deformation; Material Deformation

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR. REPORT # 3005099803-2021-08057). IT WAS REPORTED BOSTON SCIENTIFIC CORPORATION THAT A ADVANIX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2021. DURING PREPARATION, WHEN THE GUIDEWIRE WAS TRIED TO PUT THROUGH THE ADVANIX PANCREATIC STENT, THE STENT BECAME KINKED. IT WAS REPORTED THAT THIS HAPPENED WITH TWO ADVANIX PANCREATIC STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX PANCREATIC STENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE AS "NO PATIENT COMPLICATIONS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13175029 ↗
• MalfunctionFeb 17, 2017Material Deformation; 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 ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, AFTER UNDERGOING AN OPERATION (OPERATION TYPE NOT REPORTED), THE PHYSICIAN USED A SINGLE BALLOON IN THE INTESTINAL TRACT AND ATTEMPTED TO PLACE THE ADVANIX PANCREATIC STENT IN THE PANCREATIC DUCT. DUE TO SEVERE TORTUOSITY UP TO THE TARGET AREA, WHEN THE PHYSICIAN TRIED TO DEPLOY THE ADVANIX PANCREATIC STENT, THE STENT DEFORMED INTO ¿BELLOW-LIKE¿ SHAPE WITHOUT APPLYING TOO MUCH FORCE TO THE STENT. THE DEVICE WAS REMOVED FROM THE PATIENT SINCE IT WAS UNABLE TO BE DEPLOYED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITH NO COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6339028 ↗