Advanix™ Pancreatic Stent M00536880Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729856474), received between Apr 15, 2019 and Sep 17, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 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.

• MalfunctionSep 17, 2026Break

  It was reported to Boston Scientific Corporation that an Advanix Pancreatic stent was attempted to be implanted to treat stones during a stone removal procedure performed on August 25, 2026. During procedure, the stent broke while loading on wire. The procedure was completed using another of the same device. There are no patient complications reported as result of the procedure. There was no patient complications reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805834 ↗
• MalfunctionJan 10, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC PIGTAIL STENT WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS PARTIALLY INSERTED INTO THE BIOPSY VALVE BUT HAD TO BE REMOVED TO REPOSITION THE GUIDEWIRE; HOWEVER, THE STENT BROKE INTO TWO PIECES WHEN IT WAS GRABBED BY HAND TO SLIDE INTO THE GUIDEWIRE. A SECOND STENT WAS USED TO COMPLETE THE PROCEDURE. THERE ARE NO KNOWN PATIENT COMPLICATIONS DUE TO THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21123701 ↗
• MalfunctionJan 8, 2025Break; Entrapment of Device; Use of Device Problem; Break; Entrapment of Device; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS IMPLANTED TO TREAT A BILIARY STENOSIS IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THEY BEGAN INTRODUCING THE GUIDEWIRE INTO THE OPERATING CHANNEL, THE PHYSICIAN LOST THE BILE DUCT GUIDE WIRE. AS A RESULT, THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT FROM THE OPERATING CHANNEL BY PULLING IT UPWARD. HOWEVER, THE STENT BROKE INTO HALF AT THE BIOPSY VALVE. REPORTEDLY, NO STENT WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX PANCREATIC STENT. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE GUIDEWIRE WAS IN THE PANCREATIC DUCT DURING DEPLOYMENT. HOWEVER, THE ADVANIX PANCREATIC STENT INSTRUCTIONS FOR USE (IFU) STATES THAT, "TO FULLY DEPLOY THE STENT, UNLOCK THE GUIDEWIRE FROM THE BOSTON SCIENTIFIC RX LOCKING DEVICE, AND COMPLETELY RETRACT THE GUIDEWIRE INTO PUSHER". HOWEVER, THIS STEP WAS NOT FOLLOWED BY THE USER. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION RECEIVED ON DEC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106908 ↗
• MalfunctionMay 6, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE AMPULLA, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, OUTSIDE THE PATIENT, IT WAS NOTICED THAT THE PIGTAIL OF THE STENT WAS BROKEN. 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 10029249 ↗
• MalfunctionApr 15, 2019Break; Break

  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, THE GUIDEWIRE WAS STIFFED AND PUNCTURED A HOLE IN TO THE STENT. 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 8514957 ↗