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Advanix™ Pancreatic Stent M00536430Recalls & 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 08714729857372), received between Apr 30, 2018 and Apr 30, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Packaging Compromised” (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 Packaging Compromised1

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.

  • MalfunctionApr 30, 2018Device Packaging Compromised; Device Packaging Compromised

    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 UNPACKING, THE SEAL OF THE PACKING WAS NOT FIXED ENOUGH AND IT HAD A GAP/OPENING. THE PLASTIC BAG OF THE PRODUCT GOT DAMAGE/TORN. NO FURTHER ISSUES WERE REPORTED WITH THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7472501 ↗

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Sources and updates

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