Advanix™ Pancreatic Stent M00537130Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729856603), received between Sep 3, 2024 and Apr 24, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Difficult to Advance; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED IN THE PANCREATIC DUCT TO TREAT A MASS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE STENT FAILED TO CROSS THE STENOSIS, AND THE PHYSICIAN FOUND A TEAR IN THE FRONT OF THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND 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 24990365 ↗
• MalfunctionSep 3, 2024Positioning Failure; Use of Device Problem; Material Deformation; Positioning Failure; Use of Device Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED IN THE COMMON BILE DUCT TO TREAT PAIN CAUSED BY DUODENAL PAPILLARY STENOSIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT COULD NOT OPEN AND DEPLOY WHEN IT ENTERED THE STENOSIS AREA ALONG THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX PANCREATIC STENT. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: IT WAS REPORTED THAT THE BARB FLAP COVER WAS NOT USED TO INSERT THE DEVICE THROUGH THE BIOPSY CAP. PER THE ADVANIX PANCREATIC STENT INSTRUCTIONS FOR USE (IFU), "SLIDE THE STENT BARB COVER SECURELY INTO THE BIOPSY CAP". THE USER DID NOT FOLLOW THE IFU. THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE BASED ON THE INVESTIGATION RESULT WHICH REVEALED THAT THE PANCREATIC STENT TIP WAS BENT. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20129658 ↗