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Advanix™ Pancreatic Stent M00536290Recalls & 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 08714729857235), received between Dec 15, 2020 and Dec 15, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unsealed Device Packaging” (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

  • Unsealed Device Packaging1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 15, 2020Unsealed Device Packaging; Unsealed Device Packaging

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS RECEIVED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, UPON INSPECTION, IT WAS FOUND THAT THE DEVICE PACKAGE WAS RIPPED. THERE WERE NO PATIENT INVOLVEMENT AS REPORTED IN THIS EVENT. A PHOTO OF THE DEVICE WAS PROVIDED, SHOWING THAT THE STENT PACKAGE WAS TORN.

    Patient problems: No Patient Involvement

    MAUDE report 11013311 ↗

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Sources and updates

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