Advanix™ Pancreatic Stent M00537290Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729856887), received between Apr 27, 2020 and Mar 25, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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.

• MalfunctionMar 25, 2025Entrapment of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ADVANIX PANCREATIC STENTS WERE TO BE IMPLANTED TO TREAT AN UNKNOWN INDICATION IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). DURING THE PROCEDURE, BOTH STENTS WERE UNABLE TO BE ADVANCED OVER THE GUIDEWIRE. BOTH STENTS GOT STUCK AND BENT SLIGHTLY AT THE TIPS. A THIRD ADVANIX PANCREATIC STENT 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 21687015 ↗
• MalfunctionMar 21, 2025Entrapment of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS IMPLANTED TO TREAT AN UNKNOWN INDICATION IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). NOTE: BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. DURING THE PROCEDURE, THEY WERE UNABLE TO ADVANCE THE STENT OVER THE WIRE. BOTH STENTS STUCK AND BENT SLIGHTLY AT THE TIPS. ANOTHER ADVANIX PANCREATIC STENT 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 21664892 ↗
• MalfunctionJul 18, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING A PROCEDURE IN THE PANCREATIC DUCT, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY FROM THE PUSHER. ANOTHER ADVANIX PANCREATIC STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF PANCREATIC STENT DEFORMED AND DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15045992 ↗
• MalfunctionNov 18, 2020Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING UNPACKING, THE BARB SLEEVE COVER OF THE ADVANIX PANCREATIC STENT WAS LOOSE FROM THE SEALED PLASTIC THERMOFORMED BLISTER TRAY AND WAS FOUND IN THE PLASTIC POUCH. THE STERILITY OF THE DEVICE WAS CONFIRMED TO BE COMPROMISED SO THE PHYSICIAN DISCONTINUED USE OF THIS DEVICE. ANOTHER ADVANIX PANCREATIC STENT WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT ISSUES. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED SHOWING THE BARB SLEEVE COVER OUT OF ITS ORIGINAL POSITION WITHIN THE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10862592 ↗
• InjuryAug 5, 2020Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS PLACED IN THE BILE DUCT OF A PATIENT DURING AN ENDOSCOPIC BILIARY DRAINAGE PROCEDURE. THE EXACT IMPLANT DATE WAS NOT REPORTED, HOWEVER, THE STENT WAS REPORTED TO HAVE BEEN INDWELL FOR APPROXIMATELY ONE MONTH. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2020 THE ADVANIX PANCREATIC STENT WAS NOTED TO HAVE MIGRATED OUT OF THE BILE DUCT, CAUSING A PERFORATION OF THE COLON. THE PATIENT REQUIRED ADDITIONAL OPEN SURGERY TO TREAT THE PERFORATION. THE MIGRATED STENT WAS EXPLANTED FROM THE PATIENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE SURGERY WAS REPORTED TO BE STABLE.

  Patient problems: No Code Available; Perforation

  MAUDE report 10367446 ↗
• MalfunctionApr 27, 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 THE PROCEDURE, INSIDE THE PATIENT, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE STENT COULD NOT PASS THROUGH THE STRICTURE SITE OF THE ANATOMY. ANOTHER ADVANIX PANCREATIC STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. 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 OF PANCREATIC STENT BENT/KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10000784 ↗