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Epic™ E200-21ARecalls & reported problems

St. Jude Medical, Inc. · Stented Tissue 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 05415067033017), received between Apr 7, 2023 and Apr 7, 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.

  • MalfunctionApr 7, 2023Incomplete Coaptation; Incomplete Coaptation

    IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM EPIC PLUS AORTIC VALVE WAS CHOSEN FOR IMPLANT. THE PATIENT ANNULUS WAS SIZED USING A 21MM BARREL END SIZER. WHILE ATTEMPTING TO THREAD THE VALVE, IT WAS DETERMINED THAT THE VALVE LEAFLET WAS NOT MOVING. THE 21MM VALVE WAS REMOVED AND A 19MM SJM MASTERS SERIES VALVE EXPANDED CUFF WAS INSERTED. THE 19MM SIZER WAS ABLE TO ENTER THE ANNULUS WELL. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT WAS REPORTED AS STABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16704739 ↗

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Sources and updates

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