Epic™ EMAX-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05415067045478), received between Mar 15, 2024 and Sep 11, 2026 — classified as 5 injuries, 3 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. 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 8 most recent of 8 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) SH Device Registry, Patient Site ID: (b)(6).It was reported that on (b)(6) 2026, a 23mm Epic Max Aortic Valve was chosen for implant. Post-procedure, patient became hypotensive and subsequently received medication. Patient status was reported resolved less than 12 hours post-procedure.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 50734199 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  CRD_1032 - SH Device Registry, Patient Site ID: (b)(6)(R1012345801).It was reported that on (b)(6) 2026, a 23mm Epic Max Aortic Valve was chosen for implant. It was then reported on (b)(6)2026, patient experienced bilateral pleural effusion and subsequently required bilateral thoracentesis procedure.

  Patient problems: Pleural Effusion

  MAUDE report 50099162 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  (b)(4) Device Registry, Patient Site ID: (b)(6). It was reported that on (b)(6) 2026, a 23mm Epic Max Aortic Valve was chosen for implant. It was then reported on (b)(6) 2026, patient experienced heart failure with diffuse hypokinesia, severely dilated left ventricle, and atrial fibrillation with recurrence despite pharmacological cardioversion. Patient was administered medication.

  Patient problems: Atrial Fibrillation; Heart Failure/Congestive Heart Failure; Movement Disorder

  MAUDE report 50099009 ↗
• InjuryMar 28, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM EPIC MAX VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. THE VALVE WAS SIZED USING A SIZER. IT WAS NOTED DURING PROCEDURE, THAT THE LEAFLET OF THE EPIC MAX VALVE WAS NOT COAPTING SPECIFICALLY CLOSING, RESULTING IN SEVERE AORTIC INSUFFICIENCY. THERE WAS NO DIFFICULTY NOTED WITH THE VALVE OPENING COMPLETELY. THE 23MM EPIC MAX VALVE FULLY IMPLANTED/SUTURED AT THIS POINT. THE LEAFLETS OF THE VALVE HAD BEEN VISUALLY INSPECTED DURING DEVICE PREPARATION. THE 23MM EPIC MAX VALVE WAS NOT MISHANDLED OR DAMAGED DURING PREPARATION. THE DECISION WAS MADE TO EXPLANT THE VALVE AND REPLACE IT WITH A 23MM NON-ABBOTT DEVICE. THE PATIENT NEVER CAME OFF CARDIOPULMONARY BYPASS. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. THERE WAS NO INITIAL OR PROLONGED HOSPITALIZATION DUE TO THIS EVENT. THE PATIENT WAS STABLE AND RECOVERED UNEVENTFULLY AT THE TIME OF REPORT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21722387 ↗
• InjuryJul 10, 2024Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON 18 JUNE 2024, A 23MM EPIC MAX VALVE WAS IMPLANTED IN A PATIENT WITH NO APPARENT CONCERN. UPON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) EVALUATION, A PROMINENT LEAK WAS OBSERVED STARTING AT THE CENTER OF THE VALVE WHICH CONTINUED DOWN TOWARD THE LEAFLET. THIS WAS NOT A PARAVALVULAR LEAK. IT WAS THOUGHT THAT THIS LEAK MAY HAVE BEEN LEAFLET RELATED. PATIENT WAS PUT BACK ON BYPASS AND A SECOND 23MM EPIC MAX WAS IMPLANTED. TEE REVEALED NORMAL FLOW AND VALVE APPEARANCE. PATIENT WAS EXTUBATED AND IS RECOVERING IN STABLE CONDITION.

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

  MAUDE report 19716123 ↗
• MalfunctionJun 4, 2024Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2024, AN UNKNOWN EPIC MAX VALVE WAS IMPLANTED IN A PATIENT. AFTER IMPLANT THE PHYSICIAN NOTICED ONE OF THE LEAFLETS WAS NOT FUNCTIONING. HE EXPLANTED THE VALVE AND PUT ANOTHER IN THE PATIENT. THE PATIENT IS STABLE,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19463691 ↗
• MalfunctionApr 4, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 23MM EPIC MAX VALVE WAS CHOSEN FOR IMPLANT FOR A BICUSPID AORTIC VALVE. THE VALVE WAS IMPLANTED AND TIED DOWN. AFTER THE VALVE WAS SEATED AND THE SUTURES WERE TIED, IT WAS NOTED THAT THE RETROGRADE CARDIOPLEGIA WAS NOT COMING FREELY OUT OF THE RIGHT CORONARY ARTERY (RCA), AND THERE WAS CONCERN OF POSSIBLE OBSTRUCTION OF THE OSTIUM TO THE RCA. IT WAS BELIEVED THAT DUE TO THE BICUSPID AORTIC VALVE ANATOMY THE CORONARY OSTIUM FOR THE RCA WAS NOT IN THE TRADITIONAL LOCATION. THE VALVE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A 21MM NON-ABBOTT VALVE WHILE THE PATIENT REMAINED ON CARDIOPULMONARY BYPASS. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19043306 ↗
• MalfunctionMar 15, 2024Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2024, A 23MM EPIC MAX VALVE WAS CHOSEN FOR IMPLANT. THE PATIENT HAD A SIEVERS 0 BICUSPID. ONCE THE SUTURES WERE PLACED, THE VALVE LEAFLETS DID NOT APPEAR TO COAPT CORRECTLY. THE VALVE WAS REMOVED, AND A REPLACEMENT 23MM NON-ABBOTT VALVE WAS IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18915937 ↗