Epic™ ESP200-19Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05415067033116), received between Feb 2, 2023 and Jul 27, 2026 — classified as 1 death, 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Stenosis” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Device Stenosis

  It was reported that on (b)(6) 2026, a 19mm Epic Plus Supra Valve was chosen for a procedure. The valve was implanted as per the standard surgical protocol. Following weaning from cardiopulmonary bypass (CPB), intraoperative transesophageal echocardiogram TEE demonstrated persistently high transvalvular gradients across the prosthesis (PPG/MPG: 70/46 mmHg). After a thorough evaluation, no technical, anatomical, or surgical cause, including left ventricular outflow tract obstruction (LVOTO), was identified. The patient was placed back on CPB, the valve was explanted, and a non-Abbott mechanical valve was implanted. Repeat TEE showed satisfactory valve function with acceptable gradients (PPG/MPG: 30/17 mmHg). The patient was subsequently weaned off CPB successfully, and the remainder of the procedure was uneventful. The patient was shifted to the intensive care unit (ICU) with stable hemodynamics. There was no delay in the procedure. The patient was reported discharged.

  Patient problems: Aortic Valve Stenosis; Obstruction/Occlusion

  MAUDE report 50011375 ↗
• InjuryJul 27, 2026Material Split, Cut or Torn

  It was reported that on (b)(6)2026, a 19mm Epic Plus Supra Valve and 27mm Epic Plus Mitral Valve were implanted in the patient for double valve replacement (DVR) procedure. On (b)(6)2026, the patient presented with breathless & nauseous. After the echocardiogram, it was noted that both the valves have leaflet tears. A redo-surgery was performed on (b)(6) 2026 with 19mm Epic Plus Supra Valve and 27mm Epic Plus Mitral Valve. The patient was reported stable.

  Patient problems: Nausea

  MAUDE report 50009838 ↗
• DeathNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 23556077 ↗
• InjuryMar 13, 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 PLUS SUPRA VALVE WAS CHOSEN FOR A PROCEDURE. THE DEVICE WAS SIZED CORRECTLY AND IMPLANTED. POST IMPLANTATION, IT WAS OBSERVED THAT THE VALVE WAS TOO TIGHT AND OBSTRUCTING THE OSTIA. THE SURGEON DECIDED TO EXPLANT THE VALVE. THE VALVE WAS EXPLANTED AND A NEW 17MM NON-ABBOTT VALVE WAS IMPLANTED. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Coronary obstruction/occlusion

  MAUDE report 21598979 ↗
• MalfunctionFeb 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2025, A 19MM EPIC VALVE WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, WHILE THE SUTURE NEEDLE WAS BEING USED ON THE CUFF, THE OUTER/DISTAL SIDE OF THE NCC CUFF HAD BECAME TORN. THE VALVE WASN'T USED, THE ANNULUS WAS ENLARGED, AND A 21MM EPIC VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS A 30 MINUTE DELAY ASSOCIATED WITH THE ANNULUS DILATION, BUT THERE WERE NO PATIENT CONSEQUENCES. THE PATIENT'S CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21422874 ↗
• InjuryDec 30, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2024, A 19MM EPIC PLUS SUPRA VALVE WAS SELECTED FOR IMPLANT. DURING PROCEDURE, THE EPIC VALVE WAS SEATED WELL. HOWEVER, POST-IMPLANT, THE VALVE APPEARED TOO TIGHT AND CAUSED HIGH GRADIENTS. THE VALVE WAS EXPLANTED AND A NEW 17MM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS SUCCESSFULLY IMPLANTED. THERE ARE NO ALLEGATION OF MALFUNCTION WITH THE 19MM EPIC VALVE. THE USER ALLEGED THAT THE CAUSE OF THE HIGH GRADIENTS WAS THAT THE 19MM EPIC WAS TOO SMALL. HIGH GRADIENT DID NOT PERSIST AFTER THE 19MM EPIC WAS EXPLANTED. THE PATIENT WAS REPORTED TO HAVE BEEN DISCHARGED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21038289 ↗
• MalfunctionAug 29, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 19MM EPIC PLUS SUPRA VALVE WAS CHOSEN FOR IMPLANT. AFTER SIZING, THE VALVE WAS ATTEMPTED TO BE DEPLOYED. HOWEVER, DURING STITCHING, THE PHYSICIAN FELT RESISTANCE. THERE WAS NO ISSUE WITH THE VALVE CUFF OR THE SUTURE. THE VALVE WAS CHANGED TO ANOTHER 19MM EPIC PLUS SUPRA VALVE, WHICH WAS SUCCESSFULLY IMPLANTED. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20103304 ↗
• InjurySep 25, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17808132 ↗
• MalfunctionFeb 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2023, A 19MM EPIC PLUS SUPRA VALVE WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, WHILE IMPLANTING THE VALVE, THE SUTURES CAME OUT FROM ONE SIDE OF THE HOLDER. THE SURGEON EVENTUALLY MANAGED TO IMPLANT THE SAME VALVE WITH NO CONSEQUENCE TO THE PATIENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16305278 ↗
• InjuryFeb 2, 2023Patient-Device Incompatibility; Device Stenosis; Patient-Device Incompatibility; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2023 A 19MM EPIC PLUS VALVE WAS IMPLANTED INTO A PATIENT. ON (B)(6) 2023 IT WAS NOTED THAT THE PATIENT HAD A HIGH GRADIENT OF 62; THE PATIENT WAS ASYMPTOMATIC. NO STENOSIS WAS OBSERVED. BLOOD THINNERS WAS PROVIDED. THE PATIENT WAS REPORTED TO HAVE BEEN DISCHARGED.

  Patient problems: Valvular Stenosis

  MAUDE report 16287642 ↗