Advanix™ Pancreatic Stent M00537260Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729856856), received between Oct 17, 2019 and Sep 4, 2026 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Use of Device Problem; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600410 ↗
• MalfunctionNov 24, 2025Positioning Failure; Use of Device Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Use of Device 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 TO TREAT A MALIGNANT PANCREATIC DUCT STRICTURE IN THE PANCREATIC DUCT HEAD REGION DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY. ANOTHER ADVANIX PANCREATIC STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS 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 IFU, "SLIDE THE OUTER ORANGE SLEEVE OVER THE MOST PROXIMAL STENT BARB TO HOLD IT DOWN FOR STENT INSERTION." THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU). NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF STENT KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638985 ↗
• MalfunctionAug 27, 2025Use of Device Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED TO TREAT A STRICTURE IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO ADVANCE THE STENT OVER THE GUIDEWIRE. UPON REACHING THE AMPULLA, IT WAS OBSERVED THAT THE DISTAL PORTION OF THE STENT, SPECIFICALLY BENEATH THE LEADING BARB, APPEARED 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 GUIDEWIRE WAS IN THE PANCREATIC DUCT, DURING THE ATTEMPTED DEPLOYMENT. PER THE INSTRUCTION FOR USE, "IF THE GUIDEWIRE IS NOT COMPLETELY RETRACTED INTO THE DELIVERY SYSTEM, THE STENT CANNOT BE FULLY DEPLOYED.". ADDITIONAL INFORMATION RECEIVED ON AUGUST 15, 2025: IT WAS REPORTED THAT THERE WAS A 10-MINUTE DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22907075 ↗
• MalfunctionJul 9, 2025Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT PIGTAIL LEADING BARB 7F 7CM WAS TO BE IMPLANTED IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PIGTAIL PART OF THE STENT WAS BROKEN, PREVENTING THE ORANGE PUSHER PART FROM ADVANCING DESPITE BEING PUSHED. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JULY 17, 2025. THE REPORTED COMPLAINT OCCURRED OUTSIDE THE BODY, PRIOR TO DEVICE INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22465000 ↗
• MalfunctionSep 5, 2024Component Missing; Component Missing

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED IN THE PANCREATIC DUCT TO TREAT A PANCREATIC STONE DURING A PANCREATIC STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED. HOWEVER, THE ENDOSCOPIC MARKER ON THE DUODENAL SIDE OF THE STENT WAS DIFFICULT TO VIEW. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20152829 ↗
• MalfunctionJun 23, 2023Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE PANCREAS, PERFORMED ON (B)(6) 2023. DURING PREPARATION, IT WAS FOUND THAT THE DISTAL PART OF THE STENT WAS KINKED. ANOTHER ADVANIX PANCREATIC STENT WAS OPENED AND 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 17190143 ↗
• MalfunctionJul 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX DELIVERY SYSTEM AND AN ADVANIX PANCREATIC STENT WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN THE PANCREATIC DUCT PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY A PANCREATIC PIGTAIL TO ENSURE DRAINAGE. WHEN THE NAVIFLEX RX DELIVERY SYSTEM WAS ADVANCED TO THE STENT, THE GUIDE CATHETER BROKE INTO TWO. THE BROKEN PIECE OF GUIDE CATHETER WAS RETRIEVED WITH A SNARE. ALL BROKEN PIECE OF GUIDE CATHETER WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX-NAVIFLEX PANCREATIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THE STENT WAS DAMAGED, THEREFORE THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT FOR THE ADVANIX PANCREATIC STENT. PLEASE SEE FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14911388 ↗
• MalfunctionJun 29, 2021Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING A STENT PLACEMENT PROCEDURE IN THE MAIN PANCREATIC DUCT PERFORMED ON (B)(6) 2021. DURING PROCEDURE, IT WAS NOTED THAT THEY HAD DIFFICULTY RETRACTING THE NAVIFLEX DELIVERY SYSTEM. MORE FORCE WAS APPLIED BUT THE STENT BECAME KINKED AND COULD NOT BE RELEASED. 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 AS "NO PATIENT INJURY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12086142 ↗
• MalfunctionOct 17, 2019Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING A PROCEDURE, PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THEY ATTEMPTED TO LOAD THE STENT ONTO THE NAVIFLEX7FR, IT WAS DIFFICULT FOR THEM TO SET UP OR PREPARE. WHEN REPLACED WITH ANOTHER OF THE SAME DELIVERY SYSTEM, IT MOUNTED SMOOTHLY AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; PANCREATIC STENT KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9202337 ↗