Epic™ E200-31MRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 05415067033093), received between Aug 9, 2023 and Sep 25, 2026 — classified as 2 deaths, 20 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (6 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  CRD_1032 - SH Device Registry, Patient Site ID: (b)(6).It was reported that on (b)(6) 2026, a 31mm Epic Plus Mitral Valve was chosen for implant. Post-procedure on (b)(6) 2026, patient experienced atrial fibrillation as well as repeated bradycardic episodes with asymptomatic pauses on 13 August 2026. Atrial fibrillation transitioned to a brief episode of asystole on 15 August 2026. There was also a pause on bradycardia followed by tachycardic conduction. Patient symptoms were consistent with sick sinus syndrome. Patient was administered medication and underwent two sessions of electrical cardioversions with no result. No further significant pauses occurred until discharge. On 19 August 2026, patient had an ejection fraction of 35% and subsequently received a life vest for three months. It was also reported patient experienced a urinary tract infection on (b)(6) 2026 and was treated with antibiotics same day.

  Patient problems: Atrial Fibrillation; Bradycardia; Cardiac Arrest; Heart Failure/Congestive Heart Failure; Tachycardia; Unspecified Infection

  MAUDE report 50897780 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Anemia; Arrhythmia; Atrial Fibrillation; Bradycardia; Cardiac Arrest; Low Blood Pressure/ Hypotension; Respiratory Insufficiency; Tachycardia

  MAUDE report 50175468 ↗
• MalfunctionJul 31, 2026Perivalvular Leak; Material Deformation

  It was reported on (b)(6) 2026, a 31mm Epic Plus Mitral Valve was chosen for a procedure. After ligation, the cuff and shield sections were generally sewn together with uniform stitching; however, a portion was found to have non-uniform spacing, with a gap of approximately 1.5 stitch intervals. There was Para leak was noted. The valve remains implanted and has not been explanted. The patient was reported stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50098430 ↗
• InjuryJul 27, 2026Patient-Device Incompatibility

  CRD_(b)(4) - SH Device Registry, Patient Site ID: (b)(6). It was reported that on (b)(6) 2025, a 31mm Epic Plus Mitral Valve was chosen for implant. On (b)(6) 2026, patient presented to emergency department due to episodes compatible with transient ischemic attack. Computed tomography scan ruled out data of acute intracranial pathology. It was later reported on (b)(6) 2026, patient presented with a fever of 38C and chills of approximately three weeks duration. Patient was diagnosed with late prosthetic valve endocarditis of the Epic Plus Mitral Valve caused by streptococcus mutans. Antibiotic medication was initiated. During hospitalization, patient was also evaluated by neurology and diagnosed with left hemispheric ischemic stroke of cardioembolic etiology in context of endocarditis on biological prosthetic valve and anticoagulated atrial fibrillation.

  Patient problems: Endocarditis; Stroke/CVA; Transient Ischemic Attack

  MAUDE report 50019833 ↗
• InjuryJul 27, 2026Patient-Device Incompatibility

  (b)(4) - SH Device Registry, Patient Site ID: (b)(6).It was reported that on (b)(6) 2025, a 31mm Epic Plus Mitral valve was chosen for implant. It was then reported on (b)(6) 2026, a large, mobile 20mm vegetation was noted, indicative of endocarditis. An urgent decision was made to perform redo-surgical mitral valve replacement with a 29mm Epic Plus Mitral valve on (b)(6) 2026.

  Patient problems: Endocarditis

  MAUDE report 50019131 ↗
• InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem

  CRD (B)(4) SH DEVICE REGISTRY, PATIENT SITE ID: (B)(6).IT WAS REPORTED THAT ON (B)(6) 2026, A 31MM EPIC PLUS MITRAL VALVE WAS CHOSEN FOR IMPLANT. POST-PROCEDURE, PATIENT EXPERIENCED SEVERAL EPISODES OF POST-OPERATIVE BLEEDING AND HEMOTHORAX. PATIENT WAS GIVEN BLOOD TRANSFUSIONS. REOPERATION WAS PERFORMED ON (B)(6) 2026 FOR REMOVAL OF LARGE CLOT. IT WAS THEN REPORTED ON (B)(6) 2026, PATIENT EXPERIENCED PERSISTENT ATRIAL FIBRILLATION. AN ELECTROCARDIOVERSION WAS PERFORMED ON (B)(6) 2026 AND PATIENT WAS SUCCESSFULLY CONVERTED TO SINUS RHYTHM. PATIENT WAS ALSO ADMINISTERED POTASSIUM AND MAGNESIUM ON (B)(6) 2026.

  Patient problems: Atrial Fibrillation; Hemorrhage/Blood Loss/Bleeding; Hemothorax

  MAUDE report 25780487 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  CRD_(B)(4) - SH DEVICE REGISTRY, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2026, A 31MM EPIC PLUS MITRAL VALVE WAS CHOSEN FOR IMPLANT. POST-PROCEDURE ON (B)(6) 2026, PATIENT EXPERIENCED INTERMITTENT ATRIAL FIBRILLATION. CARDIOVERSION THERAPY WAS PROVIDED ON (B)(6) 2026, AND THE PATIENT WAS CONVERTED TO SINUS RHYTHM.

  Patient problems: Atrial Fibrillation

  MAUDE report 25682253 ↗
• MalfunctionMar 30, 2026No Apparent Adverse Event; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2026, A 31MM EPIC PLUS MITRAL VALVE WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, THE YELLOW PLASTIC VALVE CONNECTION PREMATURELY FELL OFF WHILE SURGEON WAS ABOUT TO IMPLANT. THE VALVE FELL ON THE FLOOR AS A RESULT AND ONE-CUT SUTURE DISCONNECTED WITHOUT BEING CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24737093 ↗
• MalfunctionMar 6, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2025, A 31MM EPIC PLUS MITRAL VALVE WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, IT WAS NOTED THAT THE VALVE PROSTHESIS GOT INJURED DURING THE SEATING PROCESS. A NEW 31MM EPIC PLUS VALVE WAS CHOSEN AND COMPLETED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24530988 ↗
• MalfunctionFeb 20, 2026Calcified

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401853 ↗
• MalfunctionFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 31MM EPIC PLUS VALVE WAS IMPLANTED INTO THE PATIENT. AFTER THE PROCEDURE, THE GRADIENT IN THE OPERATIVE ROOM (OR) WAS 6. THE PHYSICIAN MENTIONED THERE WAS MODERATE STENOSIS. THERE WAS INTERVENTION PERFORMED. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Mitral Valve Stenosis

  MAUDE report 24307596 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Atrial Fibrillation

  MAUDE report 24020606 ↗
• InjuryDec 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 31MM 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 23872472 ↗
• InjuryDec 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 31MM 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 23872271 ↗
• InjuryDec 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 31MM 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 23871684 ↗
• InjuryDec 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 31MM 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 23871420 ↗
• MalfunctionNov 21, 2025Intravalvular regurgitation; Intravalvular regurgitation

  N/A.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23617954 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(6), PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 31MM EPIC PLUS MITRAL VALVE WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2025, THE PATIENT HAD BRADYCARDIA-TACHYCARDIA SYNDROME AND MEDICATIONS ADMINISTRATED. A EPICARDIAL PACEMAKER WAS IMPLANTED.

  Patient problems: Bradycardia; Tachycardia

  MAUDE report 23427826 ↗
• MalfunctionOct 10, 2025Incomplete Coaptation; Material Split, Cut or Torn; Incomplete Coaptation; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2025, A 31MM EPIC PLUS MITRAL VALVE WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, AN ISSUE WAS NOTED WHILE OPENING ON THE CUFF. THE VALVE WAS REPLACED WITH A 29MM EPIC PLUS MITRAL VALVE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE BUT THE PATIENT STAYED ON CARDIOPULMONARY BYPASS FOR A LONGER TIME. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23266015 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: CRD_1032 - SH DEVICE REGISTRY, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON 11 JUNE 2025, A 31MM EPIC PLUS MITRAL VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. POST-PROCEDURE, IT WAS NOTED THAT THE PATIENT DEVELOPED CARDIOGENIC SHOCK THAT REQUIRED THE PATIENT BE PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). AFTER A POSITIVE OUTCOME THE PATIENT WAS ABLE TO WEAN OFF ECMO AFTER 7 DAYS. THERE WERE NO FURTHER INCIDENTS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure/Congestive Heart Failure; Shock

  MAUDE report 22927035 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(6) - SH DEVICE REGISTRY, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 31MM EPIC PLUS MITRAL VALVE WAS SUCCESSFULLY IMPLANTED A PATIENT. NO DIFFICULTY WAS ENCOUNTERED DURING THE IMPLANTATION OF THE 31 MM EPIC PLUS MITRAL VALVE. IN THE FIRST FEW HOURS POST-SURGERY, THE PATIENT EXPERIENCED HYPERTENSION WITH SYSTOLIC BLOOD PRESSURE PEAKS OF 180¿220 MMHG, LEADING TO ELEVATED MEDIASTINAL DRAINAGE OUTPUT (1,100 ML IN 7 HOURS). SURGICAL REVISION WAS PERFORMED, REVEALING DIFFUSE BLEEDING FROM THE STERNAL AREA, LIKELY DUE TO THE HYPERTENSIVE EMERGENCY, BUT NO ACTIVE BLEEDING AT CARDIAC SUTURES. A MODERATE 18MM PERICARDIAL EFFUSION WAS ALSO NOTED TO HAVE DEVELOPED, WHICH IMPROVED AFTER MEDICATION ADJUSTMENT. DUE TO THE SEVERITY OF BLEEDING, HEPARIN WAS NOT ADMINISTERED, AND ACTIVATED CLOTTING TIME (ACT) LEVELS WERE NOT AVAILABLE. AT THE TIME OF RE-OPERATION, THE INTERNATIONAL NORMALIZED RATIO (INR) WAS 1.25, AND AT DISCHARGE, IT WAS 1.22. ONE POOL OF PLATELETS WAS TRANSFUSED IN THE INTENSIVE CARE UNIT (ICU) BEFORE REINTERVENTION, WITH NO FURTHER TRANSFUSIONS REQUIRED. THERE IS NO ALLEGATION OF MALFUNCTION AGAINST THE ABBOTT DEVICE OR PROCEDURE. THE

  Patient problems: Fatigue; Hemorrhage/Blood Loss/Bleeding; High Blood Pressure/ Hypertension; Pericardial Effusion

  MAUDE report 22749322 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(4) DEVICE REGISTRY, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 31MM EPIC PLUS MITRAL VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. THE PATIENT¿S BASELINE RHYTHM WAS ATRIAL FIBRILLATION WITH A CONTROLLED VENTRICULAR RESPONSE OF APPROXIMATELY 60 BPM. POST-PROCEDURE, IT WAS NOTED THAT THE PATIENT DEVELOPED A COMPLETE HEART BLOCK THERE WAS NO DIFFICULTY EXPERIENCED DURING THE IMPLANTATION OF THE 31MM EPIC PLUS MITRAL VALVE. COMPLETE HEART BLOCK WAS CONFIRMED BY ELECTROCARDIOGRAPHIC EVIDENCE SHOWING A VENTRICULAR RATE OF 30 BPM, WITH NO IMPROVEMENT OBSERVED 10 DAYS POST-SURGERY, ON (B)(6) 2025, THE DECISION WAS MADE TO IMPLANT A PERMANENT PACEMAKER. NO ALLEGATIONS OF MALFUNCTION WERE MADE AGAINST THE ABBOTT DEVICE OR PROCEDURE. THE PATIENT DID NOT EXHIBIT ANY OTHER CLINICAL SIGNS OR SYMPTOMS DURING OR AFTER THE EVENT. THE PATIENT UNDERWENT AORTIC AND MITRAL VALVE REPLACEMENT, WHICH THE IMPLANTING PHYSICIAN BELIEVES CAUSED THE COMPLETE HEART BLOCK. THE PATIENT WAS DISCHARGED ON THE 13TH POSTOPERATIVE DAY AND IS CURRENTLY IN GOOD CLINICAL CONDITION.

  Patient problems: Heart Block

  MAUDE report 22710825 ↗
• DeathApr 22, 2025Nonstandard Device; Patient-Device Incompatibility; Nonstandard Device; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, A 31MM EPIC VALVE WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, AFTER PARACHUTING THE VALVUE DOWN INTO THE ANNULUS, AND REMOVING THE VALVE FROM THE HOLDER, IT WAS NOTED THAT THERE WAS A BENT LEAFLET ON THE VALVE. THE FOLD WAS NOTED ON THE FREE EDGE OF THE VEIL, NEAR ITS JUNCTION WITH THE POLE. IT WAS ATTRIBUTED THAT THIS WAS DUE TO THE CALCIFICATION OF THE NATIVE VALVE. THE VALVE WAS REMOVED AND ANOTHER ABBOTT VALVE WAS USED TO COMPLETE THE PROCEDURE. THE PHYSICIAN ALLEGED THAT THERE WAS "HARDENING" ON THE ABBOTT VALVE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PHYSICIAN DOESN'T BELIEVE THE PATIENT OR USER EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT. ON THE SAME DAY, THE PATIENT PASSING AWAY. THE PHYSICIAN CLASSIFIES THIS DEATH AS BEING RELATED TO THE PROCEDURE AND THE PATIENT¿S COMORBIDITIES. THE IMPLANTER DOES NOT CLASSIFY THAT THE DEATH IS RELATED TO THE FUNCTION/PERFORMANCE OF THE IMPLANTED DEVICE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 21885752 ↗
• InjuryDec 20, 2024Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2024, A 31MM EPIC MITRAL VALVE WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, ONCE THE VALVE WAS IMPLANTED AND THE PATIENT WAS TAKEN OFF OF BYPASS, IT WAS NOTED VIA ECHO THAT THERE WAS PARAVALVULAR LEAK. THE PATIENT WAS PLACED BACK ON BYPASS AND TAKEN BACK TO THE OPERATING ROOM FOR REPAIR. THE SURGERY WAS TIME WAS EXTENDED DUE TO THE ISSUE AND WAS DONE UNDER EXTRACORPOREAL CIRCULATION. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20989318 ↗
• InjuryNov 27, 2024Incomplete Coaptation; Intravalvular regurgitation; Incomplete Coaptation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2024, A 31M EPIC MITRAL VALVE (SERIAL: (B)(6)) WAS CHOSEN FOR IMPLANTATION. PRE PROCEDURE MITRAL REGURGITATION WAS GRADE 3+. AFTER IMPLANT AND IMMEDIATELY AFTER REVERSING CARDIOPLEGIA, A SMALL LEAFLET PROLAPSE WAS OBSERVED RESULTING IN MITRAL REGURGITATION GRADE 1+. NO INTERVENTION WAS PERFORMED AND PATIENT WAS DISCHARGED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 20796846 ↗