Epic™ EMAX-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05415067045447), received between Feb 28, 2024 and Sep 11, 2026 — classified as 2 deaths, 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 13 most recent of 13 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: (b)(6).It was reported that on (b)(6) 2026, a 21mm Epic Max Aortic Valve was chosen for implant. The patient also received a 25mm Epic Plus Mitral Valve for a concomitant double valve replacement procedure. The procedure was uneventful. Following protamine administration, patient developed severe left ventricular dysfunction and was placed on extracorporeal membranous oxygenation (ECMO). It was then reported on (b)(6) 2026, patient presented with respiratory failure of multifactorial origin, initially secondary to acute pulmonary edema and subsequently secondary to ventilator-associated pneumonia. A tracheostomy was performed and patient was administered antibiotics. Patient was weaned off of ECMO on post-op day 8, (b)(6) 2026. On (b)(6) 2026, patient experienced a slow awakening, An urgent computed tomography (CT) scan revealed findings consistent with ischemic stroke of subacute evolution in the territory of the right posterior cerebral artery. A magnetic resonance imaging (MRF) performed 5 days later showed signs of hemorrhagic transformation. It was reported the patient had a good neurological outcome and was discharged with the need

  Patient problems: Arrhythmia; Pulmonary Edema; Respiratory Insufficiency; Stroke/CVA

  MAUDE report 50733677 ↗
• InjuryApr 10, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Device Stenosis

  CLINICAL INFORMATION: (B)(4) - SH DEVICE REGISTRY, PATIENT SITE ID: SITE ID- (B)(6) ((B)(4)). IT WAS REPORTED THAT ON (B)(6) 2025, A 21MM EPIC MAX VALVE WAS IMPLANTED IN THE PATIENT. ON THE 5TH POST OPERATIVE DAY, THE PATIENT PRESENTED WITH PERSISTENT ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSES THAT WAS DIFFICULT TO CONTROL. THE PATIENT REQUIRED COMBINATION OF HIGH DOSE BETA BLOCKERS AND MEDICATIONS. THE PATIENT SUBSEQUENTLY PROGRESSED TO COMMON ATRIAL FLUTTER. THE PATIENT GOT DISCHARGED WITH ANTICOAGULATION AND A ELECTRICAL CARDIOVERSION WAS CONSIDERED. THE FLUTTER RESOLVED SPONTANEOUSLY.

  Patient problems: Aortic Valve Stenosis; Atrial Fibrillation; Atrial Flutter; Cardiac Arrest; Dyspnea; Endocarditis; Fever; Low Blood Pressure/ Hypotension; Pseudoaneurysm

  MAUDE report 24844277 ↗
• InjuryMar 10, 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) 2026, A 21MM EPIC MAX VALVE WAS CHOSEN FOR A PROCEDURE. POST PROCEDURE, LEFT APICAL PNEUMOTHORAX WAS NOTED. PREOPERATIVE ACTIVATED CLOTTING TIME (ACT) WAS 106. HEPARIN WAS ADMINISTERED AT 300 IU/KG. AFTER THE IMPLANT, IN THE OPERATING ROOM, THE PATIENT PRESENTED WITH CARDIAC TAMPONADE AND REQUIRING RE-STERNOTOMY. A BLEEDING WAS NOTED IN THE AORTOTOMY AREA AND A BLOOD TRANSFUSION WAS PERFORMED. THE REASON FOR POST OPERATIVE APICAL PNEUMOTHORAX PROBABLY DUE TO ACCIDENTAL INTEROPERATIVE OPENING OF THE RIGHT PLEURA. FINAL ACT WAS 126. BASELINE INTERNATIONAL NORMALIZED RATIO (INR) WAS 1.08. IT WAS NOT MEASURED INTRAOPERATIVELY. POSTOPERATIVELY, IT WAS AROUND 1.36¿1.20. IN THE MOST RECENT LAB TEST ON (B)(6) 2026, THE INR WAS 1.10. THE BLEEDING FROM THE AORTOTOMY, WHICH WAS REINFORCED WITH ADDITIONAL SUTURES. THE PATIENT ALSO HAD A FIBRINOGEN AND PLATELET DEFICIENCY. THEY KEPT PLEURAL DRAINAGE TUBE PAVED INTRAOPERATIVELY FOR ONE MORE DAY.

  Patient problems: Cardiac Tamponade; Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 24562683 ↗
• MalfunctionJan 9, 2026Incomplete Coaptation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 21MM EPIC MAX VALVE WAS CHOSEN FOR A AORTIC VALVE REPLACEMENT (AVR) PROCEDURE. THE SIZING WAS PERFORMED CONFIRMED THAT THERE WERE NO ISSUES. THE ANNULAR DIMENSIONS OF THE NATIVE VALVE WAS 23MM. WHEN THE BIOPROSTHETIC VALVE WAS DEPLOYED, ONE OF THE LEAFLETS WAS FOUND TO BE FLIPPED. THE HOLDER WAS REMOVED, AND THE LEAFLET WAS TOUCHED WITH FORCEPS, BUT IT SEEMED TO HAVE TAKEN A SET, SO ITS USE WAS DISCONTINUED. THE VALVE WAS REPLACED WITH A 19 MM EPIC MAX VALVE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WHILE PATIENT ON BYPASS. THE OPERATIVE TIME WAS PROLONGED BUT THE PATIENT WAS FINE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019769 ↗
• InjuryDec 4, 2025Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2025, A 21MM EPIC MAX VALVE WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2025, A FRACTURE OF THE LEAFLET TIP WAS NOTED. THE VALVE WAS EXPLANTED AND A NEW 33MM EPIC MAX VALVE WAS IMPLANTED. THE PATIENT WAS ORIGINALLY IN CRITICAL CONDITION BUT IS NOW SHOWING SIGNS OF RECOVERY AND IS PREPARING FOR DISCHARGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716540 ↗
• InjuryOct 21, 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). IT WAS REPORTED THAT ON (B)(6) 2025, A 21MM EPIC MAX VALVE WAS CHOSEN FOR IMPLANT. DURING PROCEDURE, AN AORTIC WALL TEAR WAS NOTED. A PERICARDIUM PATCH WAS PLACED IN NON-CORONARY SINUS. ON (B)(6) 2025, PRE-ACUTE PULMONARY EDEMA VS PNEUMONIA WAS NOTED AND IT GOT RESOLVED WITH DIURETICS, ANTIBIOTICS AND NEBULIZATION. THE PATIENT WAS DISCHARGED 15 DAYS AFTER SURGERY WITH MINIMAL PERICARDIAL EFFUSION WITHOUT SIGNS OF HEMODYNAMIC COMPROMISE AND CLINICALLY STABLE.

  Patient problems: Pneumonia; Pulmonary Edema; Vascular Dissection

  MAUDE report 23352790 ↗
• InjurySep 8, 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). IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM EPIC MAX VALVE WAS SELECTED FOR IMPLANT. THE AORTIC VALVE AREA WAS 210 CM2. IT WAS NOTED THAT AFTER AORTIC MEASUREMENT THE 23MM EPIC MAX VALVE SHOULD HAVE FIT, BUT WAS ULTIMATELY UNABLE TO BE IMPLANTED. THERE WAS NO ALLEGATION OF MALFUNCTION AGAINST THE EPIC VALVE OTHER THAT MIS-SIZING. THE DECISION WAS MADE TO REPLACE THE 23MM EPIC MAX VALVE WITH A 21MM EPIC MAX VALVE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THERE WAS NO DELAY IN THE PROCEDURE. ON (B)(6) 2025, IT WAS NOTED THAT THE PATIENT HAD A THIRD DEGREE HEART BLOCK AND A PERMANENT PACEMAKER WAS IMPLANTED. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Heart Block

  MAUDE report 22994191 ↗
• MalfunctionJul 1, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2025, A , 21MM EPIC MAX VALVE WAS CHOSEN FOR A PROCEDURE. THE HATIVE ANNULUS DIAMETER WAS 21 MM. AFTER THE VALVE WAS IMPLANTED, DURING A WATER TEST, IT WAS FOUND THAT THERE WAS A SLIT-LIKE HOLE IN THE VALVE LEAFLET. THE VALVE WAS REPLACED WITH A NEW 21MM EPIC MAX VALVE INTRA-PROCEDURALLY, WHILE THE PATIENT WAS STILL ON BYPASS. THE PATIENT WAS REPORTED RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22375303 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 21MM EPIC MAX VALVE WAS SELECTED FOR IMPLANT. THE VALVE WAS SIZED USING AN EPIC MAX SIZER SET. IT WAS NOTED DURING PROCEDURE, THAT THERE WAS DIFFICULTY CLOSING THE AORTA DUE TO THE BULKY STENT POSTS, EVEN AFTER USING THE DOUBLE-ENDED SIZERS. THE DECISION WAS MADE TO ENLARGE THE AORTIC ROOT AND USE NON-ABBOTT PATCHES. THE VALVE WAS ABLE TO BE SUCCESSFULLY IMPLANTED IN THE AORTIC VALVE WITH EXCELLENT RESULTS. THERE WAS NO INITIAL OR PROLONGED HOSPITALIZATION DUE TO THIS EVENT. THERE IS NO ALLEGATION OF MALFUNCTION AGAINST THE 21MM EPIC MAX VALVE OR PROCEDURE. THE PATIENT WAS IN STABLE CONDITION AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22056179 ↗
• InjuryJul 9, 2024Material Deformation; Intravalvular regurgitation; Material Deformation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON 13 JUNE 2024, A 21MM EPIC MAX VALVE WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, THE VALVE WAS IMPLANTED AND WHEN THE PUMP WAS OFF A LEAK WAS NOTED, THEY MENTIONED SOMETHING WRONG WITH THE LEAFLETS. THE PHYSICIAN WENT BACK ON PUMP AND THE VALVE WAS REMOVED AND A NEW 21MM EPIC MAX VALVE WAS IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS A DELAY IN THE PROCEDURE BUT NOT HEMODYNAMICALLY COMPROMISED. THE PATIENT WAS REPORTED STABLE AND DISCHARGED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19698354 ↗
• InjuryMay 24, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT AN UNKNOWN SIZE EPIC MAX VALVE WAS IMPLANTED IN THE FALL OF 2023. THE TRANSVALVULAR GRADIENT OF FOLLOWING IMPLANT WAS LESS THAN 10 MMHG. SEVERAL MONTHS LATER, THE PATIENT UNDERWENT EVALUATION WITH A TRANSTHORACIC ECHOCARDIOGRAM (TTE) DEMONSTRATING AN ELEVATED TRANSVALVULAR GRADIENT. THE PATIENT WAS SCHEDULED FOR A TEE TO FURTHER ASSESS THE VALVE PERFORMANCE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 19395653 ↗
• DeathMar 6, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2024, A 21MM EPIC MAX VALVE WAS CHOSEN FOR IMPLANT IN A 77-YEAR-OLD WOMAN. DURING THE PROCEDURE, IT WAS NOTED THAT THE CORRESPONDING 21MM EPIC MAX REPLICA END OF THE SIZER WAS DIFFICULT TO PASS THROUGH THE SINOTUBULAR JUNCTION (STJ) AND IN THE PROCESS OF FORCING THE SIZER THROUGH THE STJ THERE WAS AN INJURY CAUSED TO THE AORTA. DESPITE THE DIFFICULTIES IN PASSING THE 21MM EPIC MAX REPLICA END OF THE SIZER THROUGH THE STJ THE PHYSICIAN DECIDED TO IMPLANT AN EPIC MAX 21MM VALVE. THE PHYSICIAN HAD DIFFICULTY SEATING THE EPIC MAX 21MM VALVE ON TOP OF THE ANNULUS AND HAD TO PATCH THE AORTA TO FIT THE VALVE. WHEN THE PATIENT WAS TAKEN OFF CARDIOPULMONARY BYPASS, THERE WERE CONCERNS ABOUT A BLOCKED RIGHT CORONARY ARTERY, SO A SAPHENOUS VEIN GRAFT WAS TAKEN AND BYPASSED TO THE RIGHT CORONARY ARTERY. THERE CONTINUED TO BE DIFFICULTY SEPARATING FROM CARDIOPULMONARY BYPASS SO AN INTERNAL MAMMARY ARTERY WAS TAKEN AND BYPASSED TO THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE PATIENT CONTINUED TO HAVE DIFFICULTY SEPARATING FROM CARDIOPULMONARY BYPASS, SO SHE WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND TRANSFERRED TO CARDIOVASCULAR INTENSI

  Patient problems: Obstruction/Occlusion

  MAUDE report 18852506 ↗
• DeathFeb 28, 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 21MM EPIC MAX VALVE WAS CHOSEN FOR IMPLANT IN A 64-YEAR-OLD FEMALE PATIENT) WITH A HISTORY OF AORTIC INSUFFICIENCY, CORONARY ARTERY DISEASE AND HYPERTENSION. THE PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT (AVR) WITH A CONCOMITANT CORONARY ARTERY BYPASS GRAFTING (CABG) TO THE LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) USING THE LEFT INTERNAL MAMMARY ARTERY (LIMA). THE PATIENT HAD A SMALL AORTIC ROOT WITH THIN AORTIC TISSUE AND AN AORTIC ENLARGEMENT WAS REQUIRED. THE AORTIC VALVE WAS SIZED FOR A 21 MM EPIC MAX VALVE USING THE REPLICA SIZER END OF THE EPIC MAX SIZER SET. THE 21 MM SIZER FIT WAS GOOD, AND A DECISION WAS MADE TO IMPLANT THE 21MM EPIC MAX VALVE. THE EPIC MAX 21MM WAS IMPLANTED WITHOUT DIFFICULTY WITH THE SUTURES SECURED USING COR-KNOTS. AFTER COMING OFF CARDIOPULMONARY BYPASS IT WAS NOTED THAT THERE WAS BLEEDING FROM THE BASE OF THE AORTA IN THE NON-CORONARY SINUS WITH VISIBLE PLEDGETS CONSISTENT WITH AN AORTIC-VENTRICULAR SEPARATION. THE PATIENT WAS PLACED BACK ON CARDIOPULMONARY BYPASS AND THE EPIC MAX 21MM VALVE WAS REMOVED TO EXPOSE THE AREA OF BLEEDING. THE AORTIC BLEEDING SITE WAS REPAIRED WITH AUTOLOGOUS PERICARDIAL TI

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 18801100 ↗