Advanix™ Pancreatic Stent Kit M00537360Recalls & reported problems
Boston Scientific Corporation · Pancreatic Stent Kit · Class 2 · Implant
All models of Advanix Pancreatic Stent Kit (13)
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 08714729856351), received between Feb 17, 2017 and Jul 22, 2021 — 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 Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2021Material Deformation; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE PANCREATIC DUCT PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE STENT WAS TRIED TO INSERT INTO THE SCOPE CHANNEL OF THE ENDOSCOPE, IT WAS NOTED THAT THE STENT WAS SLIGHTLY KINKED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DIFFERENT DEVICE MODEL. 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 12210858 ↗MalfunctionFeb 17, 2017Material Deformation; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING PANCREATIC DUCT STENT PLACEMENT PROCEDURE PERFORMED IN THE PANCREATIC DUCT ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THE STENT FLAP WAS DEFORMED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 "NO COMPLICATION".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6338739 ↗
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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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