Advanix™ Pancreatic Stent M00536870Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729856467), received between May 17, 2019 and Dec 30, 2025 — classified as 1 injury, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 23926910 ↗
• MalfunctionOct 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 TO BE IMPLANTED IN THE PANCREATIC DUCT (HEAD REGION) TO TREAT A MALIGNANT PANCREATIC DUCT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS TIGHT PRIOR TO STENT PLACEMENT. DURING PREPARATION, IT WAS REPORTED THAT THE STENT WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 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 IFU; THEREFORE, THIS COMPLAINT HAS BEEN ASSIGNED AR CODE 5191: 2457 TO CAPTURE USER ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302778 ↗
• MalfunctionJul 18, 2025Material Deformation; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22545962 ↗
• MalfunctionJul 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED INTO A TIGHT STRICTURE 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 22543677 ↗
• InjuryFeb 26, 2025Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS IMPLANTED FOR PANCREATIC DUCT DRAINAGE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THEY HAD DIFFICULTY REMOVING THE GUIDEWIRE, WHICH RESULTED IN DAMAGE TO THE GUIDE WIRE WITHIN THE STENT. THE DISTAL PART OF THE STENT ALSO BROKE AND WAS REMOVED USING FORCEPS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE ORIGINAL METHOD AND/OR DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21470173 ↗
• MalfunctionNov 23, 2022Material 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) 2022. DURING PROCEDURE, IT WAS NOTED THAT THE DISTAL PIGTAIL OF THE STENT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15852356 ↗
• MalfunctionMay 17, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE PANCREATIC DUCT PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO BACK-LOAD THE ADVANIX PANCREATIC STENT OVER A GUIDEWIRE, THE GUIDEWIRE PUNCTURED A HOLE THROUGH THE STENT. THE PHYSICIAN CONFIRMED THAT THE GUIDEWIRE DID NOT GO THROUGH ONE OF THE FENESTRATION HOLES OF THE STENT. THE PROCEDURE WAS COMPLETED WITH THIS ADVANIX PANCREATIC STENT IN PLACE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8621846 ↗