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Epic™ E100-27A-00Recalls & reported problems

St. Jude Medical, Inc. · St. Jude Medical Porcine Aortic Bioprosthetic Heart Valve · Class 3 · Implant

All models of Epic (26)

Data updated Oct 16, 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 05414734055567), received between Feb 28, 2023 and Feb 28, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incomplete Coaptation” (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 16, 2026.

Most reported problems

Device problems

  • Incomplete Coaptation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionFeb 28, 2023Incomplete Coaptation; Incomplete Coaptation

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 27MM EPIC AORTIC STENTED PORCINE VALVE WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, THE SURGEON OBSERVED THAT LEAFLETS APPEARED "STUCK" AND WOULDN'T OPEN. IT IS UNKNOWN IF A NEW DEVICE WAS IMPLANTED. THE PATIENT STATUS IS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16455436 ↗

Other heart-valve, non-allograft tissue devices

All heart-valve, non-allograft tissue devices →

Sources and updates

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