Epic™ ESP200-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05415067033147), received between Mar 9, 2022 and Aug 7, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Incomplete Coaptation” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Intravalvular regurgitation

  It was reported that on (b)(6) 2026, a 25mm Epic Plus Supra Valve was implanted in the patient. Three days after the procedure, the patient presented with valve insufficiency and a central regurgitation was noted on the follow up imaging. A transcatheter aortic valve implantation (TAVI) procedure was performed on (b)(6) 2026. The patient was reported stable.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50176727 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: CRD_1032 - SH DEVICE REGISTRY, PATIENT SITE (B)(6)- (B)(4). IT WAS REPORTED THAT ON (B)(6) 2025, A 15MM EPIC PLUS SUPRA VALVE WAS IMPLANTED IN THE PATIENT. AFTER THE PROCEDURE, THE PATIENT HAD A HEART BLOCK AND PACING WAS NEEDED. THE PATIENT WAS RETURNED BACK TO SINUS RHYTHM. DURING THE EARLY POSTOPERATIVE PHASE DUE TO POST-IMPLANT EDEMA/SWELLING IN THE ANNULAR REGION CAUSING CONDUCTION PROBLEMS ¿ RESOLVED AFTER EDEMA REGRESSION WITHOUT THE NEED FOR INTERVENTION. THE PATIENT HAD PNEUMONIA AND TREATED WITH ANTIBIOTICS. DURING THE POSTOPERATIVE COURSE, POTENTIALLY DUE TO HYPOVOLEMIA RESULTING IN TEMPORARY ACUTE ON CHRONIC (MILD) KIDNEY FAILURE. PNEUMONIA OCCURRED DUE TO SUPERINFECTION AND CLINICAL SYMPTOMS. ON (B)(6) 2026, THE PATIENT PRESENTED WITH A PAROXYSMAL ATRIAL FIBRILLATION (AF) AND GOT TREATED WITH AMIODARONE AND BETABLOCKER. FIVE DAYS AFTER THE PROCEDURE, THE PATIENT HAD AN ACUTE KIDNEY INJURY AND TREATED WITH VOLUME REPLACEMENT. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: Atrial Fibrillation; Heart Block; Pneumonia; Pulmonary Edema; Renal Failure

  MAUDE report 25225599 ↗
• MalfunctionApr 10, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM EPIC PLUS SUPRA VALVE WAS CHOSEN FOR A VALVE REPLACEMENT SURGERY. DURING PROCEDURE, A FAILURE IN LEAFLET COAPTATION HAD OCCURRED, ALLOWING VALVULAR INSUFFICIENCY. A NEW VALVE WAS OPENED AND COMPLETED THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845061 ↗
• InjurySep 18, 2025Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25 MM EPIC PLUS SUPRA VALVE WAS IMPLANTED IN THE PATIENT. ON AN UNKNOWN DATE, THE PATIENT SHOWED INCREASED PRESSURE GRADIENT AND A REGURGITATION WAS CONFIRMED BY ECHOCARDIOGRAPHY. THE LEAK OBSERVED FROM THE CUFF. THE VALVE WAS EXPLANTED AND A NEW 25 MM NON-ABBOTT VALVE WAS IMPLANTED. THE PATIENT WAS REPORTED DISCHARGED.

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

  MAUDE report 23084414 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON 11 DECEMBER 2024, A 25MM EPIC PLUS SUPRA VALVE WAS SELECTED FOR IMPLANT. THE VALVE WAS IMPLANTED. HOWEVER, "OWING TO FRAILITY OF AORTA PATIENTS AORTIC ANNULUS WAS GIVING AWAY IT MIGHT BE DUE TO STENTTRAMIC STIFFNESS," CARDIOPLEGIA WAS ADMINISTERED AND THE VALVE WAS EXPLANTED. IT WAS FURTHER DESCRIBED THAT THE PATIENT'S AORTA WAS FOUND TO BE TOO FRAGILE TO STITCH THE EPIC VALVE INTO PLACE. THE PATIENT THEN UNDERWENT PERICARDIAL RE-CONSTRUCTION OF THE ANNULUS IN A CONTINUOUS FASHION WITH A 5-0 PROLENE SUTURE. THEN, A NEW 10MM EPIC PLUS SUPRA VALVE WAS SUCCESSFULLY IMPLANTED. A DELAY IN OVERALL PROCEDURE TIME WAS REPORTED. THE PATIENT STATUS WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21068731 ↗
• InjurySep 20, 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 25MM EPIC PLUS VALVE WAS IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. ON (B)(6) 2024, THE VALVE WAS EXPLANTED AS THERE WAS CONCOMITANT BLEEDING FROM THE VALSALVA DAMAGE AFTER THE CARDIOPULMONARY BYPASS OPERATION. IT WAS BELIEVED THAT SINCE THERE WAS CALCIFICATION AND THE TISSUE WAS FRAGILE, THE VALSALVA MAY HAVE BEEN DAMAGED IN THE IMPLANT PROCESS. WHEN THE VALVE WAS EXPLANTED, THE CUFF WAS SLIGHTLY DAMAGED AT THE TIME OF RETRIEVAL. A BENTALL OPERATION WAS PERFORMED, AND A 25MM NON-ABBOTT VALVE WAS IMPLANTED INSTEAD. THE PATIENT WAS REPORTED AS RECOVERING. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20270830 ↗
• InjuryMar 9, 2022Incomplete Coaptation; Insufficient Device Problem Information; Incomplete Coaptation; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2022, A 25 MM EPIC PLUS SUPRA VALVE WAS SUCCESSFULLY IMPLANTED WITHOUT ISSUE. INTRAOPERATIVE ECHO PREFORMED REVEALED MODERATE AORTIC INSUFFICIENCY FROM THE DEVICE. THE PATIENT WAS PLACED BACK ON BYPASS, THE VALVE REMOVED, AND REPLACED WITH A 23 MM EPIC PLUS SUPRA VALVE TO RESOLVE THE EVENT. THERE WAS NO CLEAR CAUSE FOR THE MODERATE AORTIC INSUFFICIENCY. THE PROCEDURE WAS EXTENDED LONGER THAN IS CLINICALLY SIGNIFICANT, HOWEVER THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. THE PATIENT IS STABLE AND IS RECOVERING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 13712329 ↗