Epic™ E200-25MRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05415067033048), received between Jan 4, 2023 and Mar 20, 2026 — classified as 1 death, 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 reports).

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

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM EPIC PLUS MITRAL VALVE WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, A SEWING RING TEAR WAS NOTED. A NEW 25MM EPIC PLUS MITRAL VALVE WAS CHOSEN AND COMPLETED THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24648939 ↗
• MalfunctionMar 2, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM EPIC PLUS MITRAL VALVE WAS CHOSEN FOR A PROCEDURE. THE ANNULAR DIMENSIONS OF THE NATIVE VALVE WAS APPROXIMATELY 32¿33MM. DURING THE PROCEDURE, A MILD TO MODERATE CENTRAL LEAK WAS IDENTIFIED ON TRANSESOPHAGEAL ECHOCARDIOGRAPHY, AND THE VALVE WAS EXPLANTED AND REPLACED WITH A 25MM SJM MASTERS SERIES VALVE EXPANDED CUFF VALVE WHILE PATIENT ON BYPASS. THERE WAS A DELAY, BUT IT HAD NO IMPACT ON THE PATIENT¿S OUTCOME. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482535 ↗
• MalfunctionFeb 27, 2026Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM EPIC PLUS MITRAL VALVE WAS CHOSEN FOR A PROCEDURE. DURING THE PROCEDURE, THE HANDLE BECAME DETACHED FROM THE HOLDER DURING SUTURE PLACEMENT ON THE CUFF, AND THE VALVE WAS DROPPED. A NON-ABBOTT MITRAL VALVE WAS USED AS A SUBSTITUTE AND COMPLETED THE PROCEDURE WHILE THE PATIENT WAS ON BYPASS. THERE WAS DO DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469367 ↗
• DeathFeb 2, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM EPIC PLUS MITRAL VALVE WAS CHOSEN FOR A PROCEDURE. THE VALVE WAS IMPLANTED. TWO HOURS AFTER THE PROCEDURE, IT WAS NOTED THAT THE LEAFLETS DID NOT WORK PROPERLY AND LOSS OF PATIENT LIFE. THE CAUSE OF DEATH WAS CARDIAC ARREST. THE PHYSICIAN MENTIONED THE CAUSE OF DEATH WAS IMPLANTED DEVICE.

  Patient problems: Cardiac Arrest

  MAUDE report 24241014 ↗
• InjuryDec 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 25MM EPIC PLUS MITRAL VALVE WAS IMPLANTED IN THE PATIENT. ON AN UNKNOWN DATE, A THROMBUS FORMATION WAS NOTED AT THE SAIL POCKETS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23872659 ↗
• InjuryDec 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 25MM EPIC PLUS MITRAL VALVE WAS IMPLANTED IN THE PATIENT. ON AN UNKNOWN DATE, A THROMBUS FORMATION WAS NOTED AT THE SAIL POCKETS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23871250 ↗
• InjuryDec 9, 2025Device Stenosis; Device Stenosis

  CLINICAL INFORMATION: CRD_1032 - SH DEVICE REGISTRY, PATIENT SITE ID: (B)(6) (R958586101). IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM EPIC PLUS MITRAL VALVE WAS IMPLANTED IN THE PATIENT. POST PROCEDURE, A COMPLETE ATRIOVENTRICULAR BLOCK (AV BLOCK) WAS NOTED AND A PACEMAKER WAS ATTEMPTED. BUT SEVERE STENOSIS OF SUPERIOR VENA CAVA WAS IDENTIFIED. ON (B)(6) 2025, THE ENLARGEMENT OF THE STENOTIC ARE WITH A NON-ABBOTT PERICARDIAL PATCH WAS PERFORMED.

  Patient problems: Heart Block; Mitral Valve Stenosis

  MAUDE report 23760628 ↗
• MalfunctionFeb 3, 2025Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2024, A 25MM EPIC PLUS MITRAL VALVE WAS CHOSEN FOR A REDO MITRAL VALVE REPAIR (MVR) PROCEDURE. DURING PROCEDURE, IT WAS UNSUCCESSFUL DUE TO MITRAL ANNULUS CALCIFICATION, WHICH PREVENTED THE ANNULUS AND CUFF FROM APPROXIMATING DURING SUTURING. A HIGH LIKELIHOOD OF PARAVALVULAR LEAK (PVL) WAS NOTED AND A NEW 27MM NON-ABBOTT VALVE WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT WAS REPORTED STABLE AND THERE WAS NO ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21298818 ↗
• InjuryAug 26, 2024Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2024, A 25MM EPIC PLUS MITRAL WAS IMPLANTED IN A PATIENT. AFTER CARDIOPULMONARY BYPASS OPERATION, PVL WAS CONFIRMED, SO THE PHYSICIAN SEWED UP WITH ADDITIONAL STITCHES BUT PVL COULD NOT BE RECOVERED. A NEW 25MM EPIC PLUS MITRAL WAS IMPLANTED DUE TO PERIVALVULAR LEAK. A THE PATIENT IS STABLE, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064506 ↗
• MalfunctionJan 4, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A 25MM EPIC PLUS VALVE WAS CHOSEN FOR IMPLANT. THE DEVICE WAS SIZED USING A E2000 SIZER SET TO BE 25MM. IT WAS NOTED THAT THERE WAS DIFFICULTY ENCOUNTERED WHEN PASSING THE BARREL END OF THE SIZER THROUGH THE ANNULUS. WHEN ATTEMPTING TO IMPLANT THE EPIC VALVE, IT GOT STUCK AND COULD NOT BE ADVANCED TO THE ANNULUS. THE VALVE WAS EXPLANTED AND A 25MM NON-ABBOTT VALVE WAS CHOSEN FOR IMPLANT. WITH SOME RESISTANCE, THE REPLACEMENT DEVICE WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16098890 ↗