Epic™ E200-27MRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05415067033062), received between Nov 20, 2023 and Sep 18, 2026 — classified as 1 death, 10 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Incomplete Coaptation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Perivalvular Leak

  It was reported that on (b)(6) 2026, a 27mm Epic Plus Mitral Valve was implanted in the mitral valve position. Due to perivalvar leak (PVL), it was reimplanted, but no improvement was achieved. Subsequently, a 25mm Epic Plus Mitral Valve was implanted, and the procedure was completed. The patient was reported stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817186 ↗
• MalfunctionSep 14, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50762763 ↗
• MalfunctionSep 14, 2026Incomplete Coaptation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50762694 ↗
• InjuryJul 27, 2026Material Split, Cut or Torn

  It was reported that on (b)(6) 2026, a 19mm Epic Plus Supra Valve and 27mm Epic Plus Mitral Valve were implanted in the patient for double valve replacement (DVR) procedure. On (b)(6) 2026, the patient presented with breathless & nauseous. After the echocardiogram, it was noted that both the valves have leaflet tears. A redo-surgery was performed on (b)(6) 2026 with 19mm Epic Plus Supra Valve and 27mm Epic Plus Mitral Valve. The patient was reported stable.

  Patient problems: Nausea

  MAUDE report 50009837 ↗
• InjuryJul 13, 2026Patient-Device Incompatibility

  It was reported that on (b)(6) 2025, a 27mm Epic Plus Mitral Valve was implanted in the patient. On (b)(6) 2026, a dizziness was observed in the patient prior to resection. A mass-like attachment was found on the valve. The valve got explanted and a new 27mm Epic Plus Mitral Valve was implanted. The explanted valve had a slight pannus-like structure was attached to the commissural area. There was no tear was observed in the leaflets and suture cuff. The patient was reported stable and hospitalized.

  Patient problems: Movement Disorder

  MAUDE report 25803164 ↗
• MalfunctionApr 10, 2026Material Protrusion/Extrusion

  IT WAS REPORTED THAT ON (B)(6) 2026, A 27MM EPIC PLUS MITRAL VALVE WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, THE ANNULUS WAS SIZED, BUT THE VALVE COULD NOT BE IMPLANTED, ONE OF THE STRUTS WAS CATCHING ON SOME EXCESS TISSUE. A NEW 27MM EPIC PLUS MITRAL VALVE WAS CHOSEN AND COMPLETED THE PROCEDURE WHILE PATIENT ON BYPASS. THERE WAS SOME ADDITIONAL TIME IN THE PROCEDURE AND IT WAS UNKNOWN IF THERE WAS A PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839285 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: CRD_1032 - SH DEVICE REGISTRY, PATIENT SITE (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 27MM EPIC PLUS MITRAL VALVE WAS IMPLANTED IN THE PATIENT. AFTER THE PROCEDURE, THE PATIENT OBSERVED ANEMIA. FOUR DAYS OF THE PROCEDURE, THE PATIENT HAD HYPOKALEMIA. SOME POTASSIUM SUPPLEMENTS WERE GIVEN ON (B)(6) 2025. DUE TO PLEURAL EFFUSION AND RESPIRATORY FAILURE A THORACENTESIS WAS PERFORMED. THE PATIENT DEVELOPED A DELIRIUM AND WAS TREATED WITH MEDICATION. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: Anemia; Electrolyte Imbalance; Movement Disorder; Pleural Effusion; Respiratory Insufficiency

  MAUDE report 24548563 ↗
• MalfunctionFeb 16, 2026Material Deformation

  IT WAS REPORTED THAT ON EPIC PLUS MITRAL, 27MM EPIC PLUS MITRAL VALVE WAS CHOSEN FOR A MITRAL VALVE REPLACEMENT PROCEDURE. DURING PROCEDURE, A PART OF ONE LEAFLET WAS FOUND TO BE THIN AND TRANSLUCENT. DUE TO CONCERNS REGARDING DURABILITY, THE VALVE WAS NOT USED AND A NEW 27MM EPIC PLUS MITRAL VALVE WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24349064 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (b)(4) - SH DEVICE REGISTRY, PATIENT SITE ID: (b)(6).IT WAS REPORTED THAT ON (b)(6) 2025, A 27MM EPIC PLUS MITRAL VALVE AND 23MM EPIC MAX VALVE WERE IMPLANTED IN THE PATIENT. DURING POST OPERATIVE HOURS, PATIENT HAD A STROKE AND MEDIATIONS WERE GIVEN. AFTER IMPLANT, THE PATIENT HAD A COMPLETE ATRIOVENTRICULAR (AV) BLOCK. ON (b)(6) 2025, A PERMANENT PACEMAKER WAS IMPLANTED.

  Patient problems: Heart Block

  MAUDE report 24332077 ↗
• InjuryDec 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 27MM 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 23872145 ↗
• InjuryDec 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 27MM 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 23871557 ↗
• DeathDec 12, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 27MM EPIC PLUS MITRAL VALVE WAS CHOSEN FOR A MITRAL VALVE REPLACEMENT (MVR) SURGERY PERFORMED DUE TO MITRAL VALVE STENOSIS (MS). AFTER IMPLANTING THE VALVE, A LEFT VENTRICULAR RUPTURE WAS CONFIRMED. THE VALVE WAS REMOVED AND A NEW SJM MASTERS SERIES VALVE EXPANDED CUFF WAS IMPLANTED. AFTER THE PROCEDURE, THE HEART RATE AND BLOOD PRESSURE DID NOT RECOVER AND THE PATIENT WAS SUBSEQUENTLY DIED. AT THE TIME OF CONFIRMING THE LEFT VENTRICULAR RUPTURE, MULTIPLE TEARS WERE OBSERVED IN THE VENTRICULAR WALL. ALTHOUGH DEFINITIVE EVIDENCE WAS LACKING, IT WAS POSSIBLE THAT THE STENT POST OF 27MM EPIC PLUS MITRAL VALVE WAS STRUCK THE WALL AND CAUSED THE RUPTURE. THE CAUSE OF DEATH WAS LEFT VENTRICULAR RUPTURE.

  Patient problems: Perforation

  MAUDE report 23791141 ↗
• MalfunctionDec 2, 2025Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2025, A 27MM EPIC PLUS MITRAL VALVE WAS CHOSEN FOR A PROCEDURE. THE ANNULAR DIMENSIONS OF THE NATIVE VALVE WAS APPROXIMATELY 35 MM. DURING PROCEDURE, PROPER SIZING WAS PERFORMED, AND THE DEVICE PASSED THROUGH THE SIZER WITHOUT ISSUES. AFTER IMPLANTATION, DURING TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) ECHOCARDIOGRAM (ECHO) EVALUATION A MILD TO MODERATE PERIUVULAR LEAK (PVL) WAS OBSERVED, AND THE DEVICE WAS EXPLANTED. SUBSEQUENTLY, A NEW 25MM EPIC PLUS MITRAL VALVE WAS RE-IMPLANTED WHILE PATIENT ON BYPASS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23699304 ↗
• InjuryDec 5, 2024Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2024, A 27MM EPIC VALVE WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, SUTURES WERE PLACED ON THE MITRAL RING AND THE 27MM EPIC VALVE WAS PARACHUTED DOWN INTO THE ANNULUS AND THE SUTURES WERE TIED. LEFT ARTERIORRHAPHY WAS THEN PERFORMED FOLLOWED BY MANEUVERS TO REMOVE AIR, AND REMOVAL OF THE AORTIC CLAMP. THE FIRST ATTEMPT TO TO TAKE THE PATIENT OFF OF CARDIOPULMONARY BYPASS WAS HALTED DUE TOT HE PATIENT GOING INTO CARDIAC ARREST. CUSTODIOL WAS ADMINISTERED AND THE PROSTHESIS WAS CHECKED. ECHOCARDIOGRAM REVEALED THAT ONE OF THE LEAFLETS SHOWED RESTRICTED MOBILITY, REDUCING THE FLOW OF BLOOD FROM THE ATRIUM TO THE LEFT VENTRICLE. ANOTHER ATTEMPT TO TAKE THE PATIENT OFF CARDIOPULMONARY BYPASS, BUT AGAIN WAS NOT POSSIBLE. CUSTODIOL WAS ADMINISTERED AGAIN AND THE VALVE WAS REPLACED WITH 29MM EPIC VALVE. THE SAME RESULT OCCURRED WHILE TRYING TO TAKE THE PATIENT OFF OF CARDIOPULMONARY BYPASS. THERE WAS POOR MOBILITY OF THE PROTHESIS LEAFLETS WITH BIVENTRICULAR DYSFUNCTION. A 40MM INTRA-AORTIC BALLOON PUMP WAS IMPLANTED IN THE LEFT FEMORAL ARTERY, ALL SUPPORTS WERE ADJUSTED, AND ANOTHER ATTEMPT TO COME OFF CARDIOPULMONARY BYPASS WAS MADE WITHOUT SUCCESS. TH

  Patient problems: Cardiac Arrest

  MAUDE report 20854647 ↗
• MalfunctionOct 18, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 27MM EPIC PLUS VALVE WAS CHOSEN FOR IMPLANT. DURING PROCEDURE, THE PHYSICIAN HAD A DIFFICULTY IN ROTATING THE HANDLE TO SLIGHTLY BRING IN THE POSTS, THE VALVE WAS PARACHUTED DOWN BUT COULD NOT SEAT IT PROPERLY, HAD DIFFICULTY IN GETTING THE POSTS INTRA ANNULAR. THE VALVE WAS PULLED OUT AND A NEW 25MM EPIC VALVE WAS IMPLANTED WHILE THE PATIENT WAS STILL ON BYPASS THE PATIENT WAS REPORTED STABLE. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20481586 ↗
• MalfunctionSep 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE AND YEAR, A 27MM EPIC PLUS MITRAL WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, THE HOLDER ON VALVE FELL APART ON THE FIELD BEFORE BEING CUT FREE. THE VALVE ITSELF WAS APPARENTLY INTACT AND ABLE TO BE SUCCESSFULLY IMPLANTED. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20145782 ↗
• InjuryAug 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2024, A 27MM EPIC PLUS MITRAL VALVE WAS CHOSEN FOR MITRAL VALVE REPLACEMENT. HOWEVER, DURING IMPLANT, HOLDER HANDLE WAS UNSTABLE (WOBBLING). IN ADDITION, THE RELEASE BUTTON ON THE VALVE HOLDER WAS ACCIDENTALLY PRESSED, AND THE DEVICE WAS SEPARATED. THE PHYSICIAN ATTEMPTED TO ATTACH THE HOLDER AND THE DEVICE AGAIN, BUT IT WAS NOT SUCCESSFUL. THE DEVICE HAS BEEN SUCCESSFULLY IMPLANTED USING RATCHET MECHANISM OF THE DEVICE, AND RESULT OF CARDIAC SCINTIGRAPHY INDICATED NO ISSUES. HOWEVER, THE PHYSICIAN COMMENTED IT WAS VERY STRESSFUL EXPERIENCE SINCE THE HOLDER HANDLE AND THE DEVICE WERE UNSTABLE (WOBBLING). THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THE PATIENT CONDITION IS STABLE. THE RED CIRCLE IN THE ATTACHED PHOTO IS UNSTABLE/WOBBLING PART

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20056916 ↗
• InjuryJul 26, 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 27MM EPIC PLUS VALVE WAS IMPLANTED. AFTER THE CARDIOPULMONARY BYPASS OPERATION, THE PATIENT EXPERIENCED A DECREASE IN LEFT VENTRICULAR CONTRACTILE FORCE, AND IT WAS DISCOVERED THAT THE LEFT HEART HAD RUPTURED. IT WAS BELIEVED THAT THE CAUSE OF THE HEART RUPTURE WAS DUE TO WEAKNESS OF THE FREE WALL OF THE LEFT VENTRICLE. THE PATIENT WAS RETURNED TO SURGERY TO HAVE THE EPIC VALVE REMOVED. THE VALVE WAS REPLACED WITH ANOTHER 27MM EPIC PLUS VALVE. A PERICARDIAL PATCH WAS APPLIED TO THE FREE WALL OF THE LEFT VENTRICLE. AFTER THE SECOND OPERATION, THE PATIENT AGAIN EXPERIENCED A DECREASE IN LEFT VENTRICULAR CONTRACTILE FORCE, AND IT WAS DISCOVERED THAT THE CARDIAC RUPTURE HAD RECURRED. THE PATIENT WAS RETURNED TO SURGERY, AND THE SECOND VALVE WAS REMOVED. THE PHYSICIAN BELIEVED THAT THE CAUSE OF THE HEART RUPTURING AGAIN WAS DUE TO NOT ENOUGH REINFORCEMENT FROM THE PERICARDIAL PATCH. THE VALVE WAS REPLACED WITH A 25MM EPIC PLUS MITRAL VALVE, AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS REPORTED TO BE RECOVERING. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: Heart Failure/Congestive Heart Failure; Perforation

  MAUDE report 19841453 ↗
• InjuryJul 26, 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 27MM EPIC PLUS VALVE WAS IMPLANTED. AFTER THE CARDIOPULMONARY BYPASS OPERATION, THE PATIENT EXPERIENCED A DECREASE IN LEFT VENTRICULAR CONTRACTILE FORCE, AND IT WAS DISCOVERED THAT THE LEFT HEART HAD RUPTURED. IT WAS BELIEVED THAT THE CAUSE OF THE HEART RUPTURE WAS DUE TO WEAKNESS OF THE FREE WALL OF THE LEFT VENTRICLE. THE PATIENT WAS RETURNED TO SURGERY TO HAVE THE EPIC VALVE REMOVED. THE VALVE WAS REPLACED WITH ANOTHER 27MM EPIC PLUS VALVE. A PERICARDIAL PATCH WAS APPLIED TO THE FREE WALL OF THE LEFT VENTRICLE. AFTER THE SECOND OPERATION, THE PATIENT AGAIN EXPERIENCED A DECREASE IN LEFT VENTRICULAR CONTRACTILE FORCE, AND IT WAS DISCOVERED THAT THE CARDIAC RUPTURE HAD RECURRED. THE PATIENT WAS RETURNED TO SURGERY, AND THE SECOND VALVE WAS REMOVED. THE PHYSICIAN BELIEVED THAT THE CAUSE OF THE HEART RUPTURING AGAIN WAS DUE TO NOT ENOUGH REINFORCEMENT FROM THE PERICARDIAL PATCH. THE VALVE WAS REPLACED WITH A 25MM EPIC PLUS MITRAL VALVE, AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS REPORTED TO BE RECOVERING. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: Heart Failure/Congestive Heart Failure; Perforation

  MAUDE report 19841424 ↗
• MalfunctionNov 20, 2023Incomplete Coaptation; Incomplete Coaptation

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18177928 ↗