Advanix™ Pancreatic Stent Kit M00537350Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729856344), received between Mar 5, 2019 and Mar 5, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Entrapment of Device” (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
- Entrapment of Device1
- Problem with Sterilization1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 5, 2019Entrapment of Device; Problem with Sterilization; Entrapment of Device; Problem with Sterilization
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE DUODENUM ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2019, UPON DEPLOYING THE ADVANIX PANCREATIC STENT IN THE DUODENUM, THE PHYSICIAN WAS UNABLE TO VIEW THE STENT THROUGH THE ENDOSCOPE AND UNDER FLUOROSCOPY. THE PHYSICIAN LOOKED AROUND AND COULD NOT LOCATE THE STENT, SO IT WAS ASSUMED THAT THE STENT WAS LOST AND THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT. AFTER THE PROCEDURE, THE ENDOSCOPE UNDERWENT THE CYCLE OF DECONTAMINATION AND DISINFECTION. A FEW DAYS LATER, ON AN UNKNOWN DATE, THE SAME ENDOSCOPE WAS USED DURING A NEW ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE ON A DIFFERENT PATIENT. A TOME WAS PASSED THROUGH THE SCOPE AND IT WAS NOTICED THAT THE STENT FROM THE PREVIOUS PROCEDURE BEGAN TO EXIT THE DISTAL END OF THE SCOPE INTO THE NEW PATIENT. ONCE THIS WAS VISUALIZED, THE SCOPE WAS WITHDRAWN FROM THE PATIENT AND THE STENT WAS REMOVED COMPLETELY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8392593 ↗
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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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