Epic™ EMAX-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05415067045454), received between Nov 1, 2024 and Sep 11, 2026 — classified as 13 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Incomplete Coaptation” (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. 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.

• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  CRD (b)(4) Device Registry, Patient Site ID: US0202 - 3851 (b)(6).It was reported that on (b)(6) 2026, a 25mm Epic Max Aortic Valve was chosen for implant. During procedure, patient became hypotensive. Post-procedure, patient experienced bleeding from aortic patch and subsequently received blood product transfusions and protamine. Medication was also administered to treat continued hypotension. It was then reported on (b)(6) 2026, patient complained of increased chest pain. Electrocardiogram reported new onset atrial fibrillation, though patient remained hemodynamically stable. Medication, amiodarone, was administered and patient converted back to normal sinus rhythm. The patient's post-operative course included intermittent in and out atrial fibrillation and a self-limited run of ventricular tachycardia on (b)(6) 2026. Medication was adjusted and metoprolol was increased and replete electrolytes. Patient was discharged home in normal sinus rhythm.

  Patient problems: Angina; Atrial Fibrillation; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 50734352 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  CRD (b)(4)Device Registry, Patient Site ID: (b)(6).It was reported that on (b)(6) 2026, a 25mm Epic Max Aortic Valve was chosen for implant. Intraoperatively, patient experienced multiple episodes of ventricular fibrillation when coming off of cardiopulmonary bypass. Defibrillation was required and patient was put back on bypass. Patient continued to have a few small runs ventricular fibrillation but were self-limited. Post-procedure, patient experienced a bleeding event and over 200cc of fluid drained from chest tube in first hour. Patient was also hypotensive. Medication and 2 units of cryoprecipitate were administered. It was later reported on 25 April 2026, patient cardiac rhythm was going in and out of atrial fibrillation with heart rate in the 90-120 bpm, though remained asymptomatic. Patient self-converted back to normal sinus rhythm and intravenous medication was administered.

  Patient problems: Atrial Fibrillation; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Ventricular Fibrillation

  MAUDE report 50734262 ↗
• InjurySep 11, 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 25mm Epic Max Aortic Valve was chosen for implant. It was then reported post-procedure that patient became hypotensive and was subsequently administered medication. It was then reported on 28 March 2026, patient experienced atrial fibrillation with complaints of shortness of breath, palpitations, and feeling weak/tired. Patient heart rate was reported in the 90-100s. Patient was subsequently administered medication and converted to normal sinus rhythm. No additional or prolonged hospitalization was required. Patient status was reported discharged.

  Patient problems: Arrhythmia; Atrial Fibrillation; Dyspnea; Fatigue; Low Blood Pressure/ Hypotension

  MAUDE report 50733433 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  (b)(4) - SH Device Registry, Patient Site ID: (b)(6). It was reported that on (b)(6) 2026, a 25mm Epic Max valve was chosen for implant. Post-procedure, patient showed good progression the first few hours but subsequently developed non-ventilator associated pneumonia on (b)(6) 2026 due to H. Influenza. Patient had abundant purulent secretions with a significant increase in acute phase reactants and consolidation in the right lung base. Patient was reintubated on (b)(6) 2026. It was reported the patient initially presented with persistent hypoxemia. A bronchoscopy was performed with bronchoalveolar lavage and a positive PCR test for H. Influenza. Medication, including antibiotics, were administered from (b)(6) 2026 through (b)(6) 2026. The patient status was reported recovered and extubated on (b)(6) 2026.

  Patient problems: Anemia; Hypoxia; Pneumonia

  MAUDE report 50099612 ↗
• MalfunctionMar 30, 2026Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM EPIC MAX VALVE WAS CHOSEN FOR A PROCEDURE. A PARAVALVULAR LEAK OCCURRED AFTER IMPLANTATION OF THE VALVE. THE VALVE WAS SUBSEQUENTLY REPLACED WITH A NEW 25MM NON-ABBOTT VALVE WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716280 ↗
• InjuryMar 12, 2026Adverse 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) 2024, THE PATIENT HAD A AORTIC VALVE REPLACEMENT AND CORONARY ARTERY BYPASS SURGERY. A 25MM EPIC MAX VALVE WAS IMPLANTED IN THE PATIENT. THE PATIENT GOT DISCHARGED WITHOUT INCIDENT. THE PATIENT GOT READMITTED 24HRS LATER WITH SYNCOPE WITH COMPLETE ATRIOVENTRICULAR BLOCK. A PERMANENT PACEMAKER WAS IMPLANTED ON (B)(6) 2024.

  Patient problems: Heart Block; Syncope/Fainting

  MAUDE report 24583841 ↗
• InjuryMar 9, 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 25MM EPIC MAX VALVE WAS IMPLANTED IN THE PATIENT. AFTER THE PROCEDURE, AN ATRIAL FIBRILLATION AND R-ON-T PHENOMENON THAT DEVELOPS INTO TORSADES DE POINTES (TDP) TACHYCARDIA HAD OCCURRED. ON (B)(6) 2026, A DEFIBRILLATION WAS PERFORMED. ON (B)(6) 2026, AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IMPLANTED.

  Patient problems: Atrial Fibrillation; Tachycardia

  MAUDE report 24549005 ↗
• MalfunctionFeb 20, 2026Material Protrusion/Extrusion

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400653 ↗
• MalfunctionJan 30, 2026Intravalvular regurgitation

  CLINICAL INFORMATION: (B)(4) - SH DEVICE REGISTRY, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2024, A 25MM EPIC MAX VALVE WAS CHOSEN FOR A PROCEDURE. THE VALVE WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2025, THE VALVE SHOWED SIGNS OF STRUCTURAL PROSTHETIC DEGENERATION, THICKENING OF THE CUSP EDGES. THE IMAGE QUALITY WAS POOR BOTH FOR TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TOE) MAKING IT IMPOSSIBLE TO DETERMINE WHETHER THE THICKENING APPEARS THROMBUS LIKE OR DEGENERATIVE. THE THICKENING SHOWED SOFT APPEARANCE AND THE PROSTHETIC SHOWED MODERATE STENOSIS AND MODERATE INTRAPROSTATIC REGURGITATION. THERE WAS NO TREATMENT REQUIRED FOR REGURGITATION. THE PATIENT IS CURRENTLY BEING MONITORED IN THE SPECIALIZED VALVULAR HEART DISEASE UNIT WITHIN THE CARDIOLOGY DEPARTMENT. DEPENDING ON THE PATIENT'S PROGRESS (PROGRESSION OF GRADIENTS AND/OR SYMPTOMS, ONSET OF VENTRICULAR DYSFUNCTION, ETC.), A NEW SURGICAL PROCEDURE WILL BE CONSIDERED. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis

  MAUDE report 24223550 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Cardiac Tamponade; Hemorrhage/Blood Loss/Bleeding; Transient Ischemic Attack

  MAUDE report 23575509 ↗
• InjurySep 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(4) - SH DEVICE REGISTRY, PATIENT SITE ID: (B)(6) (R936837301). IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM EPIC MAX VALVE WAS IMPLANTED IN THE PATIENT. AFTER THE PROCEDURE, A CARDIAC TAMPONADE WAS NOTED AND A RE-THORACOTOMY WAS PERFORMED. ON (B)(6) 2025, THE PATIENT COULD NOT SPEAK COMPLETE THE SENTENCES AND WAS NOT ORIENTED TO TIME OR PLACE. A BLOOD PRESSURE DROP WAS NOTED AND INCREASED THE DROP NORADRELINE. ON (B)(6) 2025, PAROXYSMAL ATRIAL FIBRILLATION WAS NOTED AND AMIODARONE/POTASSIUM WAS ADMINISTRATED AND AN ELECTRICAL CARDIOVERSION WAS PERFORMED. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Atrial Fibrillation; Cardiac Tamponade; Low Blood Pressure/ Hypotension; Movement Disorder

  MAUDE report 23154746 ↗
• InjuryAug 27, 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 25MM EPIC MAX VALVE WAS SUCCESSFULLY IN A PATIENT WITH PRE-EXISTING SLOW ATRIAL FIBRILLATION (AF). POSTOPERATIVE ELECTROCARDIOGRAPHIC MONITORING SHOWED THE PATIENT HAD A BLOCKED AF RHYTHM REQUIRING EPICARDIAL PACING. THE ESCAPE RHYTHM WAS A RIGHT BUNDLE BRANCH BLOCK (RBBB) (QRS DURATION WAS 132 MS) AT A FREQUENCY RATE OF 35 BPM. THE PATIENT DEVELOPED A COMPLETE HEART BLOCK. THE PATIENT WAS HOSPITALIZED AND ON (B)(6) 2025, THE DECISION WAS MADE TO IMPLANT A PERMANENT PACEMAKER. THE PATIENT WAS IN STABLE CONDITION AT THE TIME OF REPORT.

  Patient problems: Heart Block

  MAUDE report 22909150 ↗
• InjuryAug 22, 2025Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  (B)(4) PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON 10 JULY 2025, A 25MM EPIC MAX AORTIC VALVE WAS CHOSEN FOR IMPLANTATION TO TREAT AORTIC STENOSIS WITH A CONCOMITANT AORTIC ROOT REPLACEMENT PROCEDURE. BASELINE RHYTHM WAS SINUS. THE VALVE WAS IMPLANTED SUPRA ANNULAR WITH NO REPORTED ISSUES. DIRECT ORAL ANTICOAGULANTS WERE PROVIDED POST PROCEDURE. SEVERAL DAYS AFTER THE PROCEDURE, THE PATIENT BEGAN EXPERIENCING FIRST DEGREE ATRIOVENTRICULAR BLOCK AS WELL AS COMPLETE RIGHT BUNDLE BRANCH BLOCK (RBBB). ON (B)(6) 2025 AN ELECTROPHYSIOLOGICAL STUDY WAS PERFORMED SHOWING A FRAGMENT BUNDLE OF HIS POTENTIAL. A PERMANENT PACEMAKER WAS THEN IMPLANTED. IN THE PHYSICIAN'S OPINION, GIVEN THE PATIENT'S SEVERE AORTIC ANNULUS CALCIFICATION, EXTENSIVE DECALCIFICATION TO FACILITATE THE ANNULAR SUTURING OF THE PROSTHETIC CONDUIT MAY HAVE DAMAGED THE CONDUCTION TISSUE.

  Patient problems: Cardiac Tamponade; Endocarditis; Heart Block; Perforation; Pericardial Effusion

  MAUDE report 22876055 ↗
• MalfunctionAug 1, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM EPIC MAX VALVE WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, IT WAS NOTED THAT ONE LEAFLET DISPLAYED A DISTINCT FOLD AND DID NOT CLOSE PROPERLY IN WATER TEST. THEREFORE THE VALVE WAS PUT ASIDE AND A NEW VALVE WAS CHOSEN AND COMPLETED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22689834 ↗
• MalfunctionMar 17, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM EPIC MAX AORTIC VALVE WAS SELECTED FOR IMPLANT. DURING DEVICE PREPARATION WHEN THE VALVE WAS BEING RINSED, "THE NURSE SAW SOMETHING ABNORMAL ON THE LEAFLET." THE VALVE WAS IMPLANTED INTO THE PATIENT AND TAKEN OFF OF BYPASS. AT THIS TIME ON ECHO, THE VALVE CONTINUED TO "LOOK ODD" AND IT WAS BELIEVED THAT THE VALVES DID NOT COAPT. A NEW 25MM EPIC MAX AORTIC VALVE WAS SUCCESSFULLY IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21625869 ↗
• InjuryMar 7, 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) 2024, A 25MM EPIC MAX VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. ON (B)(6) 2024, IT WAS NOTED THAT THE PATIENT DEVELOPED A PERICARDIAL EFFUSION AND A PLEURAL EFFUSION. THE DECISION WAS MADE TO PERFORM A PERICARDIAL DRAINAGE AND PLEURAL PUNCTURE. THE PATIENT WAS IN STABLE CONDITION AT THE TIME OF REPORT.

  Patient problems: Pericardial Effusion; Pleural Effusion

  MAUDE report 21547869 ↗
• InjuryFeb 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(4).) IT WAS REPORTED THAT ON (B)(6) 2024, 25MM EPIC MAX VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. THERE WAS NO DIFFICULTY EXPERIENCED IMPLANTING THE 25MM EPIC MAX VALVE. ON (B)(6) 2024, THE PATIENT WAS FOUND TO HAVE POST-OPERATIVE RENAL INSUFFICIENCY CONFIRMED VIA LAB TESTING. THE DECISION WAS MADE TO ADMINISTER INTRAVENOUS DIURETICS AND ACETYLCYSTEINE. THERE WAS NO INITIAL OR PROLONGED HOSPITALIZATION DUE TO THIS EVENT. THERE IS NO ALLEGATION OF MALFUNCTION AGAINST THE ABBOTT DEVICE OR PROCEDURE. THE DIRECT CAUSE OF THE PATIENT'S RENAL INSUFFICIENCY IS UNKNOWN. THE PATIENT WAS IN STABLE CONDITION AT THE TIME OF REPORT.

  Patient problems: Renal Failure

  MAUDE report 21386076 ↗
• InjuryDec 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LINICAL INFORMATION: CRD_1032 - SH DEVICE REGISTRY, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2024, A 25MM EPIC MAX VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. THERE WAS NO DIFFICULTY IMPLANTING THE VALVE, SUCH AS MULTIPLE MANIPULATIONS. DURING PROCEDURE THE PATIENT HAD A MINIMUM ACTIVATED CLOTTING TIME (ACT) LEVEL OF 164 SECONDS AND MAXIMUM ACT OF OVER 1000 SECONDS. THE PATIENT WAS ALSO ADMINISTERED 450MG OF PROTAMINSULFATE DURING PROCEDURE. THE PATIENT WAS NOT TAKING ANY ANTICOAGULANT OR ANTIPLATELET MEDICATION PRIOR TO PROCEDURE. ON (B)(6) 2024, AN ECHOCARDIOGRAM WAS PERFORMED AND REVEALED A LATERAL RIGHT VENTRICULAR PERICARDIAL EFFUSION. THE PATIENT WAS TAKING 100MG OF ACETYLSALICYLIC ACID AND LOW MOLECULAR WEIGHT HEPARIN AT THE TIME THE PERICARDIAL EFFUSION WAS NOTED. THE PATIENT WAS ADMINISTERED ANTIPHLOGISTIC. THERE WAS NO PERICARDIAL EFFUSION NOTED PRIOR TO PROCEDURE. ON (B)(6) 2024, THE PERICARDIAL EFFUSION WAS NOTED TO HAVE GROWN WITH THE LARGEST DIMENSION OF THE EFFUSION BEING 24MM. THE PATIENT ALSO DEVELOPED CARDIAC TAMPONADE. THE DECISION WAS MADE TO PERFORM A PERICARDIAL PUNCTION FOR DRAINAGE OF THE PERICARDIAL EFFUSION. THE CAUSE OF THE PATIENT'S PER

  Patient problems: Cardiac Tamponade; Hemorrhage/Blood Loss/Bleeding; Pericardial Effusion

  MAUDE report 21003881 ↗
• MalfunctionDec 11, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 25MM EPIC MAX VALVE WAS CHOSEN FOR IMPLANT. DURING PROCEDURE, THE SURGEON SIZED FOR A 25MM VALVE CORRECTLY, BUT THE VALVE DID NOT SEAT ON THE ANNULUS PROPERLY. A NEW 23MM EPIC MAX VALVE WAS CHOSEN AND COMPLETED THE PROCEDURE WHILE THE PATIENT WAS STILL ON BYPASS. THERE WAS NO REPORTED ADVERSE EVENT OCCURRED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20906208 ↗
• MalfunctionNov 1, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2024, A 25MM EPIC MAX VALVE WAS CHOSEN FOR IMPLANT DURING AN AORTIC VALVE REPLACEMENT. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OR THE PRODUCT BOX, AND THE QA SEAL WAS STILL INTACT. THERE WAS NO DAMAGE NOTED TO THE DEVICE DURING DEVICE PREPARATION. DURING THE PROCEDURE, THE VALVE WAS BEING IMPLANTED, AND IT WAS THEN NOTED THAT THE SEWING CUFF WAS DAMAGED. THE VALVE WAS REMOVED AND REPLACED WITH ANOTHER 25MM EPIC MAX VALVE, WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS DISCHARGED WITHOUT ANY COMPLICATIONS OR DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20589863 ↗