Advanix™ Pancreatic Stent M00536890Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729856481), received between Apr 30, 2020 and Aug 11, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (9 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 16, 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.

• MalfunctionAug 11, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50211002 ↗
• MalfunctionDec 30, 2025Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED DURING AN ENDOSCOPIC RETROGRADE PANCREATIC DRAINAGE (ERPD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, THE DISTAL PART OF THE STENT WAS BENT. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23927681 ↗
• MalfunctionDec 30, 2025Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED DURING AN ENDOSCOPIC RETROGRADE PANCREATIC DRAINAGE (ERPD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, THE DISTAL PART OF THE STENT WAS BENT. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926603 ↗
• MalfunctionJul 15, 2025Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS IMPLANTED DURING AN ENDOSCOPIC RETROGRADE PANCREATIC DRAINAGE (ERPD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DISTAL PART WAS BENT. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. 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 PUSHER, THE STENT CANNOT BE FULLY DEPLOYED." THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22513211 ↗
• MalfunctionJul 15, 2025Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED TO TREAT AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE DURING AN ENDOSCOPIC RETROGRADE PANCREATIC DRAINAGE (ERPD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DISTAL PART WAS BENT. ORIGINAL DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22513210 ↗
• MalfunctionMay 13, 2025Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT FOR BILIARY DRAINAGE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PANCREATIC STENT'S PIGTAIL WAS BENT. THE PHYSICIAN WAS COMFORTABLE LEAVING THE STENT IN PLACE, AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22015367 ↗
• MalfunctionApr 9, 2024Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC PIGTAIL STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC NASOBILIARY DRAINAGE (ENBD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE DISTAL PART OF THE STENT WAS KINKED. ANOTHER ADVANIX PANCREATIC STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE BARB FLAP COVER WAS NOT USED TO INSERT THE DEVICE THROUGH THE BIOPSY CAP. PER THE ADVANIX PANCREATIC STENT INSTRUCTIONS FOR USE (IFU), "SLIDE THE STENT BARB COVER SECURELY INTO THE BIOPSY CAP" THE USER DID NOT FOLLOW THE IFU AS THE USER DID NOT USE THE BARB FLAP COVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19072515 ↗
• MalfunctionJun 13, 2023Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX PANCREATIC STENT WAS USED DURING A DRAINAGE PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE STENT WAS BENT. ANOTHER ADVANIX PANCREATIC STENT WAS USED TO SUCCESSFULLY 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 17122472 ↗
• MalfunctionApr 30, 2020Material 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 COMMON BILE DUCT, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTICED THAT THE PANCREATIC STENT PIGTAIL WAS KINKED. 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 Consequences Or Impact To Patient

  MAUDE report 10015327 ↗