Epic™ E200-23ARecalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067033024), received between Dec 14, 2023 and Jul 31, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Stenosis” (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.
Reports received per month
Most reported problems
Device problems
- Device Stenosis1
- Incomplete Coaptation1
- Patient Device Interaction Problem1
Patient problems
- Aortic Valve Insufficiency/ Regurgitation1
- Aortic Valve Stenosis1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 31, 2026Patient Device Interaction Problem; Device Stenosis
It was reported that on (b)(6) 2026, a 23mm Epic Plus Aortic Valve was implanted in the patient. A follow-up was conducted on (b)(6) 2026, the patient was readmitted due to dyspnea. A significant valve stenosis and mild insufficiency were noted and a prosthetic valve thrombosis was noted in transesophageal echocardiogram (TEE) and computed tomography (CT). The clinic's protocol does not involve the use of anticoagulants following implantation¿only antiplatelet therapy. The patient was reported stable.
Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis
MAUDE report 50098122 ↗MalfunctionDec 14, 2023Incomplete Coaptation; Incomplete Coaptation
IT WAS REPORTED THAT ON 13 NOVEMBER 2023, A 23MM EPIC PLUS AORTIC VALVE WAS CHOSEN FOR AN AORTIC VALVE REPLACEMENT. THE VALVE WAS PLACED, AND CALCIFICATION WAS DETECTED IN ONE OF THE LEAFLETS OF THE EPIC VALVE THAT DID NOT ALLOW PROPER MOVEMENT, AND THE LEAFLETS WERE NOT ABLE TO CLOSE COMPLETELY. THE DEVICE WAS REMOVED AND REPLACED WITH A 21MM EPIC PLUS AORTIC VALVE. THE SURGERY TIME WAS INCREASED BY 30 MINUTES, BUT THIS DELAY DID NOT CAUSE ANY PROBLEMS FOR THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR COMPLICATIONS. THE PATIENT STATUS WAS REPORTED AS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18329435 ↗
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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