Epic™ ESP200-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05415067033130), received between Feb 17, 2023 and Sep 15, 2026 — classified as 2 deaths, 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Incomplete Coaptation” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Patient-Device Incompatibility; Patient Device Interaction Problem; Device Stenosis

  It was reported that on (b)(6) 2025, a 23mm Epic Plus Supra Valve was implanted in the patient. At the one-year postoperative follow-up examination, no abnormalities were detected on echocardiography (ECHO). On (b)(6) 2026, the patient presented with severe aortic stenosis (AS). A routine follow-up ECHO, and computed tomography (CT) examination confirmed a presence of thrombus. The valve got explanted and a new 21mm non-Abbott valve was implanted. The explanted device showed with pannus formation and thrombus on all valve leaflets. The patient was reported stable.

  Patient problems: Aortic Valve Stenosis; Thrombosis/Thrombus

  MAUDE report 50775063 ↗
• MalfunctionJun 26, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2026, A 23MM EPIC SUPRA VALVE WAS CHOSEN FOR A PROCEDURE. THE SIZING WAS PERFORMED WITH THE SIZER, AND SIZER WAS ALSO PASSED. AN INTRAOPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAPHY SHOWED PERIVALVULAR LEAK (PVL). THE VALVE GOT REMOVED AND REPLACED WITH A 21MM EPIC SUPRA VALVE WHILE PATIENT ON BYPASS. AFTER THAT, THE PVL HAD RESOLVED, AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. AFTER THE PRODUCT WAS EXPLANTED AND COMPARED WITH THE REPLICA, IT WAS APPROXIMATELY THE SAME SIZE AS 25 MM. THE PROCEDURE WAS PROLONGED BY APPROXIMATELY ONE HOUR; HOWEVER, THERE WAS NO IMPACT ON THE PATIENT. DURING THE PROCEDURE, A CUFF DAMAGE OCCURRED SPECIFICALLY WHEN THE DEVICE WAS EXPLANTED FROM THE PATIENT AFTER IMPLANTATION FOR REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25634475 ↗
• MalfunctionDec 30, 2025Material Deformation; Material Protrusion/Extrusion; Material Deformation; Material Protrusion/Extrusion

  IT WAS REPORTED THAT ON 08 DEC 2025, A 23MM EPIC PLUS SUPRA VALVE WAS CHOSEN FOR A PROCEDURE. THE ANNULAR DIMENSIONS OF THE NATIVE VALVE WAS APPROXIMATELY 23 MM. THE SIZING WAS PERFORMED AND CUFF WAS SEWN AND RECESSED, BUT USE WAS DISCONTINUED DUE TO A PERCEIVED IRREGULARITY IN THE THREAD ALIGNMENT OF THE CUFF. A NEW 23MM EPIC PLUS SUPRA VALVE WAS THEN SUBSTITUTED, SEWN AGAIN, AND THE PROCEDURE WAS COMPLETED. THERE WERE SOME ADDITIONAL TIME REQUIRED FOR RE-STITCHING DUE TO VALVE REPLACEMENT, THERE WAS NO SIGNIFICANT EXTENSION OF THE PROCEDURE TIME, AND NO IMPACT ON THE PATIENT¿S OUTCOME WAS REPORTED. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926620 ↗
• MalfunctionDec 12, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON 17 NOV 2025, A 23MM EPIC PLUS SUPRA VALVE WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, AFTER IMPLANT IT WAS NOTED THAT THE LEAFLETS WHERE NOT CLOSING PROPERLY UPON TESTING WITH A LEAFLET TESTER. THE VALVE GOT EXPLANTED AND A NEW 21MM NON-ABBOTT VALVE WAS CHOSEN AND COMPLETED THE PROCEDURE WHILE PATIENT ON BYPASS. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED STABLE AND DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790165 ↗
• MalfunctionOct 31, 2025Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM EPIC PLUS SUPRA VALVE WAS CHOSEN FOR A BENTALL PROCEDURE. DURING PROCEDURE, AN INCIDENT OCCURRED IN WHICH THE SUTURE SECURING THE HOLDER BROKE WHILE A 23 MM ESP VALVE AND A 26 MM VALSALVA GRAFT WERE BEING COMPOSITED. OUT OF THE THREE FIXATION POINTS, SUTURES AT TWO LOCATIONS WERE FOUND TO BE BROKEN. IT WAS NOTICED THAT THE VALVE WAS UNSTABLE WHEN IT WAS INSERTED INTO THE GRAFT. ACCORDING TO THE NURSE, THE INSTABILITY WAS NOT APPARENT DURING THE RINSING PROCESS. IT WAS CONSIDERED HIGHLY LIKELY THAT THE SUTURES WERE BROKEN DURING THE COMPOSITE PROCESS WITH THE GRAFT. DUE TO THE ABSENCE OF A HOLDER HANDLE DURING THE BENTALL PROCEDURE, IT WAS DETERMINED THAT SAFE IMPLANTATION WOULD BE DIFFICULT, AND THE NON-ABBOTT VALVE WAS USED INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23440188 ↗
• InjuryOct 31, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM EPIC PLUS SUPRA VALVE WAS CHOSEN FOR AN AORTIC VALVE REPLACEMENT (AVR) PROCEDURE. THE SIZING OF THE ANNULAR DIMENSIONS OF THE NATIVE VALVE WAS 23. THE VALVE WAS SUCCESSFULLY IMPLANTED. AFTER THE PROCEDURE, INTRAOPERATIVE ULTRASOUND SHOWED HIGH DIFFERENTIAL PRESSURE AND JETTING (AORTIC STENOSIS) WERE NOTED. THE CHEST WAS REOPENED, AND A 23MM NON-ABBOTT VALVE WAS IMPLANTED. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 23439233 ↗
• MalfunctionOct 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM EPIC PLUS SUPRA VALVE WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, WHEN THE VALVE WAS ATTEMPTED TO BE INSERTED A LEAFLET TEARING WAS NOTED. THE VALVE WAS REPLACED WITH A NEW 21MM DEVICE WHILE THE PATIENT WAS STILL ON BYPASS. THE PATIENT WAS REPORTED RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23209219 ↗
• MalfunctionSep 11, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM EPIC SUPRA VALVE WAS CHOSEN FOR AORTIC VALVE REPLACEMENT. VALVE WAS IMPLANTED BUT IT WAS NOTED THAT THE LEAFLETS WEREN'T COAPTING PROPERLY. ONE LEAFLET WAS NOT OPENING. THE VALVE WAS EXPLANTED AND REPLACED WITH ANOTHER 23MM EPIC SUPRA WHICH FUNCTIONED NORMALLY. THERE WERE NO PATIENT CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23031431 ↗
• DeathJul 31, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM EPIC VALVE WAS SELECTED FOR IMPLANT. AFTER THE VALVE WAS IMPLANTED AND THE CHEST WAS CLOSED, IT WAS NOTED THAT THERE WAS A SMALL HOLE ON THE LEAFLET. THE DEVICE WAS REMOVED AND REPLACED WITH A 21MM EPIC VALVE TO RESOLVE THE EVENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT WAS NOTED TO HAVE SINCE PASSED AWAY.

  Patient problems: Insufficient Information

  MAUDE report 22680039 ↗
• MalfunctionAug 29, 2024Nonstandard Device; Incomplete Coaptation; Nonstandard Device; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2024, A 23MM EPIC VALVE WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, IT WAS NOTED THAT WHEN THE VALVE WAS IMPLANTED THAT THE LEAFLETS DIDN'T COAPT PROPERLY. THE DEVICE WAS REMOVED AND REPLACED WITH A NON-ABBOTT VALVE, WHILE STILL ON BYPASS, TO RESOLVE THE EVENT. THE PHYSICIAN SAID THAT THE PROFILE OF THE VALVE DOES NOT MATCH THE SIZER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES DUE TO THE PERFORMANCE OF THE DEVICE. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20096580 ↗
• InjuryAug 21, 2024Incomplete Coaptation; Intravalvular regurgitation; Incomplete Coaptation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2024, A 23MM EPIC PLUS SUPRA VALVE WAS CHOSEN FOR A PROCEDURE. THE VALVE SEEMED TO BE COAPTING WHEN SALINE TESTED AND THE VALVE WAS IMPLANTED WITH NO NOTICEABLE ISSUE. THE LEAFLET FUNCTION WAS TESTED WITH A BULB SYRINGE WITH RED RUBBER. WHEN THE PUMP OFF, UPON ECHOCARDIOGRAM (ECHO) REVIEW, IT WAS NOTED THAT THE VALVE DEVELOPED AN ECCENTRIC CENTRAL JET THAT WAS MODERATE TO SEVERE. THE PHYSICIAN WENT BACK IN AND NOTICED THE VALVE DID NOT SEEM TO BE COAPTING AND DECIDED TO REPLACE THE VALVE. A NEW 23MM EPIC PLUS SUPRA VALVE AND COMPLETED THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS SOME DELAY IN THE PROCEDURE BUT IT WAS NOT CLINICALLY SIGNIFICANT AND THE PROCEDURE FINISHED WITHOUT FURTHER INCIDENT. THE PATIENT WAS REPORTED STABLE AND RECOVERING.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 20010390 ↗
• InjuryAug 9, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2024, A 23MM EPIC PLUS SUPRA VALVE WAS IMPLANTED. ON (B)(6) 2024, DURING ROUTINE EXAMINATION OF THE VALVE, LEAFLET TEAR WAS OBSERVED; THE PATIENT ALSO HAD ASSOCIATED SHORTNESS OF BREATH. THE CAUSE OF THE TEAR WAS SUSPECTED AS EITHER "IMPLANTED VALVE OR SOME INFECTIONS." THE INFECTION WAS FURTHER DESCRIBED AS "AR INDUCED INFECTION." THE EPIC VALVE WAS EXPLANTED AND A NON-ABBOTT ONX MECHANICAL VALVE WAS IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 19950032 ↗
• InjuryJul 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 23MM EPIC PLUS SUPRA AND 29MM EPIC PLUS MITRAL WERE ATTEMPTED TO BE IMPLANTED FOR A DOUBLE VALVE REPLACEMENT PROCEDURE. AFTER IMPLANTATION OF THE 23MM EPIC PLUS SUPRA AND 29MM EPIC PLUS MITRAL, MITRAL VALVE ANNULUS WAS NOTED TO BE TORN CONFIRMED BY ECHOCARDIOGRAM DUE TO INFECTIVE ENDOCARDITIS, WHICH CAUSED MITRAL REGURGITATION AND HEAVY AORTIC REGURGITATION. CARDIOPULMONARY BYPASS WAS SET UP AGAIN, AND TWO OF THE DEVICES WERE EXPLANTED. THE TORN VALVE ANNULUS WAS FIXED. THE SAME 29MM EPIC PLUS MITRAL WAS IMPLANTED. AND 21MM EPIC PLUS SUPRA WAS USED INSTEAD DUE TO POSSIBLE CONTACT RISKS WITH THE FIXED VALVE AND THE DEVICE.THEREFORE, THE PROCEDURE IS NOT AN OVERSIZING ISSUE NOR AORTIC REGURGITATION. THE PATIENT IS STABLE.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 19681371 ↗
• DeathFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A 23MM EPIC PLUS VALVE WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2023, THE PATIENT REPORTED TO THE HOSPITAL WITH SHORTNESS OF BREATH AND A NEW YORK HEART ASSOCIATION (NYHA) FUNCTIONAL CLASSIFICATION OF IV. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH AN INFECTION AND VEGETATION. THE PATIENT WAS DIAGNOSED WITH ENDOCARDITIS. INTRAVENOUS ANTIBIOTICS WERE ADMINISTERED, FOLLOWED BY SURGICAL REPLACEMENT. ON AN UNKNOWN DATE, THE PATIENT DIED. NO ADDITIONAL INFORMATION WAS ABLE TO BE PROVIDED BY THE HOSPITAL.

  Patient problems: Dyspnea; Endocarditis; Heart Failure/Congestive Heart Failure

  MAUDE report 16395704 ↗