Advanix™ Pancreatic Stent M00537010Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729856726), received between Nov 1, 2021 and Aug 3, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50112116 ↗
• MalfunctionAug 28, 2025Material Deformation; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22918629 ↗
• MalfunctionJun 24, 2025Material Deformation; Adverse Event Without Identified Device or Use Problem; 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 DURING AN UNSPECIFIED PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS NOT POSSIBLE FOR THE STENT TO BE SET ON THE IMPLANTING GUIDEWIRE BECAUSE THE PIGTAIL TIP WAS KINKED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22319634 ↗
• MalfunctionJun 10, 2024Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT PIGTAIL WAS TO BE IMPLANTED TO TREAT STENOSIS IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, AFTER THE STENT WAS IMPLANTED, IT WAS NOTED THAT THE STENT WAS KINKED AND WAS UNABLE TO DRAIN NORMALLY. THE PROCEDURE WAS 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 TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19499878 ↗
• MalfunctionJun 10, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT PIGTAIL WAS TO BE IMPLANTED IN THE PANCREATIC DUCT TO TREAT CHOLEDOCHOLITHIASIS WITH JAUNDICE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE STENT WAS DEPLOYED, IT WAS NOTED THAT THE PIGTAIL OF THE STENT COULD NOT CURVE NORMALLY AND WAS UNABLE TO BE FIXED. THE PROCEDURE WAS 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 TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19499349 ↗
• MalfunctionNov 1, 2021Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE PANCREATIC DUCT ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THEY HAD DIFFICULTY DEPLOYING THE STENT. 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 TO BE STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING THAT THE STENT WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12727514 ↗