Epic™ E100-25M-00Recalls & reported problems
St. Jude Medical, Inc. · St. Jude Medical Porcine Mitral Bioprosthetic · Class 3 · Implant
All models of Epic (26)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734055550), received between Sep 23, 2018 and Mar 8, 2022 — classified as 1 death, 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
- Patient-Device Incompatibility1
Patient problems
- Death1
- Mitral Valve Stenosis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 8, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT IMPLANT OF A 25 MM EPIC TISSUE HEART VALVE ON (B)(6) 2017, REQUIRED AN EXPLANT OF THE SAME VALVE ON (B)(6) 2022 DUE TO REPORTED MITRAL STENOSIS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Mitral Valve Stenosis
MAUDE report 13698891 ↗DeathSep 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
INFORMATION RECEIVED FROM THE FAMILY TO THE ABBOTT PATIENT DEVICE TRACKING IT INDICATED ON (B)(6) 2018 THE PATIENT DIED DURING THE PROCEDURE TO IMPLANT A 25 MM EPIC VALVE. THIS INTRA-PROCEDURAL DEATH IS BEING CONSERVATIVELY REPORTED AS ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.
Patient problems: Death
MAUDE report 7900680 ↗
Other heart-valve, non-allograft tissue devices
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- PERCEVAL PVS23Corcym Canada Corp · heart-valve, non-allograft tissue26 deaths337 reports
- MOSAIC® 305C23Medtronic, Inc. · heart-valve, non-allograft tissue327 reports
- MOSAIC® 305C25Medtronic, Inc. · heart-valve, non-allograft tissue2 deaths324 reports
- FREESTYLE® FR995-27Medtronic, Inc. · heart-valve, non-allograft tissue2 deaths318 reports
- FREESTYLE® FR995-29Medtronic, Inc. · heart-valve, non-allograft tissue288 reports
- FREESTYLE® FR99525Medtronic, Inc. · heart-valve, non-allograft tissue2 deaths280 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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