Epic™ EMAX-19Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05415067045461), received between Jul 26, 2024 and Jul 21, 2026 — classified as 1 death, 5 injuries.

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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 19MM EPIC MAX VALVE WAS IMPLANTED IN THE PATIENT. AFTER IMPLANTATION, AN ELEVATED PRESSURE GRADIENT WAS OBSERVED CONFIRMED BY ECHOCARDIOGRAPHY (ULTRASOUND EXAMINATION). THERE WAS NO PERIVALVULAR LEAK (PVL) WAS DETECTED. THE VALVE GOT EXPLANTED AND A NON-ABBOTT VALVE WAS IMPLANTED. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 25895514 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 19MM EPIC MAX VALVE WAS CHOSEN FOR A MINIMALLY INVASIVE AORTIC VALVE REPLACEMENT (MICS AVR) PROCEDURE. DURING PROCEDURE, THE VALVE WAS SEATED INTO THE ANNULUS AND THE OPERATION WAS COMPLETED USING A NON-ABBOTT SUTURE DEVICE. ON(B)(6) 2026, DURING FOLLOW-UP A BLEEDING WAS IDENTIFIED BECAUSE THE TIP OF THE NON-ABBOTT SUTURE DEVICE HAD PENETRATED THE AORTIC WALL, AND THEREFORE A REOPERATION WAS PERFORMED WITH A NEW 21MM EPIC MAX VALVE. TO MANAGE BLEEDING THE AORTIC WALL WAS REINFORCED USING A BOVINE PERICARDIAL PATCH. THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVELS WERE 480S AND THE INTERNATIONAL NORMALIZED RATIO (INR) WAS 2.0. A REDO AVR (WITH ANNULAR ENLARGEMENT) WAS CONDUCTED, AND THE PROCEDURE WAS COMPLETED. THE CAUSE OF BLEEDING REMAINS UNCLEAR WHETHER THE ADVERSE EVENT RESULTED FROM OVERSIZING OF THE EPIC MAX VALVE OR FROM THE ORIENTATION OF THE NON-ABBOTT DEVICE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24349417 ↗
• InjuryJan 19, 2026Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: CRD_1032 - SH DEVICE REGISTRY, PATIENT SITE ID: (B)(6), (B)(4). IT WAS REPORTED THAT ON (B)(6) 2025, A 19MM EPIC MAX VALVE WAS IMPLANTED IN THE PATIENT. DURING FIRST OPERATIVE HOURS, THE PATIENT HAD BRADYCARDIA AND NEEDED FOR TEMPORARY PACEMAKER. ON (B)(6) 2025, THE PATIENT PRESENTED WITH PAROXYSMAL ATRIAL FIBRILLATION AND REQUIRED MEDICAL TREATMENT. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: Atrial Fibrillation; Bradycardia

  MAUDE report 24111538 ↗
• DeathJun 30, 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 19MM EPIC MAX VALVE WAS SELECTED FOR IMPLANT IN A PATIENT WHO HAD UNDERGONE A PRIOR TAVI PROCEDURE. POST-PROCEDURE, THE PATIENTS CORONARY ARTERY WAS NOTED TO HAVE BECOME OCCLUDED. THE PATIENT PASSED AWAY AS A RESULT. THE PHYSICIAN BELIEVES THAT THE ARTERY WAS BLOCKED DUE TO OVERSIZING OF THE BIOPROSTHETIC AND BECAUSE THE TAVI WAS REMOVED. IT WAS ALSO NOTED AS A POSSIBILITY THAT TISSUE FRAGMENTS MAY HAVE ENTERED THE CORONARY ARTERY DURING THE REMOVAL OF THE TAVI. THE PHYSICIAN BELIEVES THAT THE EPIC DEVICE FUNCTIONED AS INTENDED AND THAT THE DEATH WAS NOT RELATED TO A PRODUCT MALFUNCTION.

  Patient problems: Coronary obstruction/occlusion

  MAUDE report 22360167 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 19MM EPIC MAX VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. THERE WAS NO DIFFICULTY EXPERIENCED IMPLANTING THE 19MM EPIC MAX VALVE. ON 14 APRIL 2025, IT'S NOTED THAT THE PATIENT SUFFERED AND ISCHEMIC STROKE TO THE POSTERIOR INFERIOR CEREBELLAR ARTERY. THERE WERE MULTIPLE LACUNAR LESIONS. IT'S NOTED THAT THE PATIENT HAD DEVELOPED ATRIAL FIBRILLATION PRIOR TO THE ISCHEMIC STROKE. THE PATIENT WAS RECEIVING SUBTHERAPEUTIC DOSES OF LOW-MOLECULAR-WEIGHT HEPARIN. THE PATIENT REPORTED SOME WEAKNESS. A BRAIN COMPUTED TOMOGRAPHY SCAN CONFIRMED THE ISCHEMIC STROKE. THE PATIENT MOTOR FUNCTION HAVE BEGUN TO IMPROVE, BUT THE PATIENT IS STILL RECOVERING. THE PATIENT WAS SWITCHED TO FONDAPARINUX DUE TO SUSPECTED HEPARIN INDUCED THROMBOCYTOPENIA. DESPITE THIS, THE PATIENT DEVELOPED THROMBOCYTOPENIA (<20,000) AND ANTI HEPARIN ANTIBODIES WERE CONFIRMED. ANALYSIS OF THE MEDICAL HISTORY REVEALED THAT THE PATIENT IMPROVED CLINICALLY ON POST-OPERATIVE DAY 16, BECOMING MUCH MORE ALERT, ALTHOUGH STILL HAD DIFFICULTY WALKING WITHOUT ASSISTANCE. THE PATIENT DID NOT EXPERIENCE A PERMANENT INJURY OR DISABILITY, WITH THEIR CONDITION HAVING GR

  Patient problems: Atrial Fibrillation; Fatigue; Movement Disorder; Stroke/CVA; Thrombocytopenia

  MAUDE report 22203738 ↗
• InjuryJul 26, 2024Incomplete Coaptation; Intravalvular regurgitation; Incomplete Coaptation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2024, A 19MM EPIC MAX VALVE WAS CHOSEN FOR A PROCEDURE. THE BODY SURFACE AREA (BSA) WAS 1.83 AND THE AORTIC VALVE WAS SUITABLE FOR EPIC MAX VALVE. THE VALVE WAS IMPLANTED ACCORDING INSTRUCTIONS FOR USE (IFU). AFTER CLOSING, THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED UNPREDICTABLE SEVERE CENTRAL JET FROM NEWLY IMPLANTED VALVE. THE JET WAS CLINICALLY UNACCEPTABLE FROM HEART TEAM AND THEY DECIDED TO EXPLANT THE VALVE. THE VALVE WAS EXPLANTED AND A NEW 19MM EPIC MAX VALVE WAS IMPLANTED. THE CENTRAL JET WAS MILD AFTER THE PROCEDURE AND HEART TEAM WAS SATISFIED WITH THE RESULT. AFTER THE PROCEDURE, HEART TEAM CHECKED THE EXPLANTED VALVE AND THEY CLAIMED ONE LEAFLET OF BIOLOGICAL VALVE WAS SHORT AND COAPTATION DEFECT. THERE WAS SOME DELAY IN THE EXPLANATION AND REIMPLANTATION PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS REPORTED IN INTENSIVE CARE UNIT (ICU).

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 19844653 ↗