Advanix™ Pancreatic Stent Kit M00537500Recalls & 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 08714729856276), received between Jan 6, 2017 and May 30, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Kinked” (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
- Kinked1
- Material Deformation1
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.
MalfunctionMay 30, 2018Material Deformation; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX¿ PANCREATIC STENT WAS USED DURING PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO USE THE DEVICE, IT WAS NOTICED THAT THERE WAS A ROUGH SPOT ON THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 "GOOD."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7554447 ↗MalfunctionJan 6, 2017Kinked; Kinked
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX¿ RX PANCREATIC STENT WAS USED IN STENT PLACEMENT PROCEDURE IN PANCREAS(EXACT DATE NOT REPORTED). ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THE ADVANIX¿ RX PANCREATIC STENT WAS BENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED ANOTHER ADVANIX¿ RX PANCREATIC STENT. 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 PROBLEM".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6229911 ↗
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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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