Advanix™ Pancreatic Stent M00536410Recalls & reported problems
Boston Scientific Corporation · Pancreatic Stent · Class 2 · Implant
All models of Advanix Pancreatic Stent (48)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729857358), received between Nov 11, 2019 and Jun 29, 2020 — 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
Device problems
- Material Deformation2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2020Material Deformation; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING A PROCEDURE IN THE PANCREAS, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, THE PHYSICIAN NOTICED THAT THE STENT WAS KINKED AND COULD NOT BE INSERTED. A 4FR 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 10207007 ↗MalfunctionNov 11, 2019Material Deformation; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING A PROCEDURE. THE EXACT EVENT DATE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GUIDE WIRE WAS STUCK INSIDE THE STENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS. INVESTIGATION RESULTS REVEALED THAT THE STENT WAS KINKED AND SEVERELY DAMAGED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9305676 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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