Advanix™ Pancreatic Stent M00537230Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729856825), received between Apr 6, 2021 and Apr 6, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).
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
- Device Difficult to Setup or Prepare1
- Material Deformation1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2021Device Difficult to Setup or Prepare; Material Deformation; Device Difficult to Setup or Prepare; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE ADVANIX PANCREATIC STENT WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY FOR STENT PLACEMENT PROCEDURE. THE ADVANIX PANCREATIC STENT KINKED AT THE PIGTAIL DESPITE ITS PLACEMENT WITH THE APPROPRIATE NAVIFLEX PUSHER. THE KINKED PANCREATIC STENT WAS SUCCESFULLY IMPLANTED INTO THE PATIENT. THERE WERE NO PATIENT ISSUES.
Patient problems: Insufficient Information
MAUDE report 11624888 ↗
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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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