Epic™ ESP200-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05415067033123), received between Nov 29, 2022 and Sep 25, 2026 — classified as 2 deaths, 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Incomplete Coaptation” (6 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Fracture

  It was reported that on (b)(6)2026, a 21mm Epic Plus Supra Valve was chosen for a procedure. Upon opening the package, no issues were found with the device, and the suture was not broken. During the procedure, the fixation suture at the connection between the valve holder and the stent post was found to be broken. The connection between the holder and the Epic Supra was detached due to a broken suture. A non-Abbott valve was chosen and completed the procedure. The patient was reported stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897732 ↗
• MalfunctionJul 31, 2026Incomplete Coaptation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50098120 ↗
• MalfunctionJul 21, 2026Incomplete Coaptation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25895647 ↗
• DeathApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 21MM EPIC PLUS SUPRA VALVE WAS IMPLANTED IN THE PATIENT. AFTER THE IMPLANT, THE OUTCOME WAS NOT FAVORABLE, GRADIENT WAS TOO HIGH. THE VALVE GOT EXPLANTED AND A NEW NON-ABBOTT VALVE WAS IMPLANTED INTRA-PROCEDURALLY WHILE THE PATIENT REMAINED ON CARDIOPULMONARY BYPASS. AFTER THE IMPLANT UNFORTUNATELY THE PATIENT DIDN¿T SURVIVE. THE EXACT CAUSE OF THE DEATH WAS NOT SPECIFIED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 24778661 ↗
• MalfunctionFeb 27, 2026Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2026, A 21MM EPIC PLUS SUPRA VALVE WAS CHOSEN FOR A PROCEDURE. DURING IMPLANTATION, IT WAS CLEARLY EVIDENT THAT ONE FLAP APPEARED TO HAVE BEEN SEWN OR FOLDED, RESULTING IN A DISTINCT ASYMMETRY IN FLAP MOVEMENT AND CONSEQUENTLY UNSATISFACTORY FLAP FUNCTION. THE VALVE GOT EXPLANTED AND A NON-ABBOTT VALVE WAS IMPLANTED WHILE THE PATIENT ON BYPASS. THERE WAS SOME DELAY IN THE PROCEDURE BUT NO PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469952 ↗
• MalfunctionJan 6, 2026Material Deformation; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 21MM EPIC PLUS SUPRA VALVE WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, THE SIZING WAS PERFORMED, AND THE VALVE CUFF WAS SEWN AND INSERTED; HOWEVER, THE USE WAS DISCONTINUED DUE TO DISCOMFORT FELT IN THE THREAD ALIGNMENT OF THE CUFF. THERE WAS SOME RESISTANCE WAS FELT. THE VALVE REPLACED WITH A NON-ABBOTT DEVICE, SEWN AGAIN, AND THE PROCEDURE WAS COMPLETED WHILE PATIENT ON BYPASS. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23980033 ↗
• MalfunctionDec 12, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 21MM EPIC PLUS SUPRA VALVE WAS CHOSEN FOR A PROCEDURE. DURING IMPLANT, THE PHYSICIAN CHECKED THE LEAFLET MOVEMENT WITH LEAFLET RUBBER TASTER IT WAS COAPTING WELL HOW EVER AFTER CLOSER OF THE AORTA THERE IS AORTIC REGURGITATION (AR) SEEN ON TRANSTHORACIC ECHOCARDIOGRAM (TEE) DUE TO POOR LEAFLET COAPTATION. THE VALVE WAS EXPLANTED A NEW 21MM NON-ABBOTT VALVE WAS IMPLANTED WHILE PATIENT ON BYPASS. THE PATIENT REMAINED HEMODYNAMICALLY STABLE HOW EVER IT CAUSES THE DELAY IN OVERALL PROCEDURE. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791069 ↗
• InjurySep 30, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AORTIC VALVE REPLACEMENT (AVR) PROCEDURE WITH A 21MM EPIC PLUS SUPRA VALVE AND CORONARY ARTERY BYPASS GRAFT SURGERY (CABG). THE ANNULAR DIAMETER OF THE NATIVE VALVE WAS 21MM. IMMEDIATE POST-OPERATIVE, THE PATIENT HAD EXERTIONAL ANGINA AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED MILD AORTIC REGURGITATION (AR). ON (B)(6) 2025, TTE DEMONSTRATED PROGRESSION TO MODERATE AR. SUBSEQUENT TTE PERFORMED ON (B)(6) 2025 CONFIRMED MODERATELY SEVERE AR (3+) WITH STABLE HEMODYNAMICS. THERE WAS NO INTERVENTION PERFORMED FOR MID AORTIC REGURGITATION (AR). THE PATIENT WAS REPORTED STABLE AND DISCHARGED.

  Patient problems: Angina; Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23184128 ↗
• MalfunctionJun 27, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 21MM EPIC SUPRA VALVE WAS SELECTED FOR IMPLANT. IMMEDIATELY POST-IMPLANT, THE LEAFLETS DID NOT CLOSE PROPERLY UPON TESTING WITH A LEAFLET TESTER. THE VALVE HAD DIFFICULTY CLOSING COMPLETELY, HOWEVER DID NOT HAVE DIFFICULTLY OPENING COMPLETELY. THE EPIC VALVE WAS EXPLANTED AND EXCHANGED FOR A NEW 19MM EPIC SUPRA VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350470 ↗
• MalfunctionJun 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 21MM EPIC PLUS SUPRA VALVE WAS CHOSEN FOR A MICS-AVR (MINIMALLY INVASIVE CARDIAC SURGERY - AORTIC VALVE REPLACEMENT) PROCEDURE. DURING PROCEDURE, THE VALVE COULD NOT PASS THROUGH THE SINO-TUBULAR JUNCTION (STJ). USING THE E2000 SIZER'S REPLICA SIZER, IT WAS CONFIRMED THAT THE STJ COULD BE PASSED, AND ANNULAR SIZING WAS PERFORMED. BASED ON THAT, THE EPIC PLUS SUPRA 21 MM VALVE WAS SELECTED. WHEN ATTEMPTING TO PARACHUTE THE 21MM EPIC PLUS SUPRA VALVE INTO THE ANNULUS, IT FAILED TO PASS THROUGH THE STJ AND THERE WAS A RESISTANCE NOTED WHILE PARACHUTING. DUE TO THE LIMITED SURGICAL FIELD IN THE MICS-AVR APPROACH AND THE RISK OF DISSECTION IF FORCED IMPLANTATION WAS ATTEMPTED, THE 21 MM VALVE WAS REMOVED. A ONE-SIZE SMALLER 19 MM EPIC PLUS SUPRA VALVE WAS RE-IMPLANTED SUCCESSFULLY INTRA-PROCEDURALLY. THE PROCEDURE TIME WAS ONLY EXTENDED BY THE TIME TAKEN TO REDO THE SUTURING (NO SIGNIFICANT EXTENSION). THERE WAS NO IMPACT ON THE PATIENT'S PROGNOSIS. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22145325 ↗
• MalfunctionFeb 28, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 21MM EPIC PLUS SUPRA VALVE WAS CHOSEN FOR IMPLANT. AFTER SIZING WAS PERFORMED, THE 21MM EPIC PLUS SUPRA VALVE COULD NOT PASS THROUGH THE SINO-TUBULAR JUNCTION. A DECISION WAS MADE TO REPLACE THE 21MM EPIC PLUS SUPRA VALVE WITH A 21MM NON-ABBOTT VALVE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21492148 ↗
• InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM EPIC PLUS SUPRA WAS CHOSEN FOR IMPLANTATION AS A AORTIC VALVE REPLACEMENT. THE PATIENT PRESENTED WITH LOWER CORONARY OSTIA HEIGHT. THE VALVE WAS IMPLANTED, BUT THE STENT POST OBSTRUCTED/IMPINGED THE CORONARY OSTIA, CAUSING BLOOD PRESSURE TO LOWER. THE VALVE WAS EXPLANTED AND A NON-ABBOTT 19MM VALVE WAS IMPLANTED AT AN INTRA-ANNULAR POSITION SUCCESSFULLY. BLOOD PRESSURE RETURNED TO NORMAL. THE PATIENT REMAINED ON CARDIO-PULMONARY BYPASS THROUGHOUT THE PROCEDURE. THERE WAS A 40 MINUTE DELAY TO REPLACE THE VALVE, WHICH RESULTED IN NO PATIENT EFFECTS OR INTERVENTION. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: Low Blood Pressure/ Hypotension; Obstruction/Occlusion

  MAUDE report 18209166 ↗
• MalfunctionNov 7, 2023Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM EPIC PLUS VALVE (SERIAL: (B)(6)) WAS CHOSEN FOR IMPLANTATION INTO A 23MM NATIVE VALVE. DURING IMPLANTATION, AFTER COMPLETING THE SUPRA ANNULAR SUTURES, WHEN THE VALVE HOLDER CAP WAS REMOVED AND VALVE WAS TESTED, ONE OF THE LEAFLETS WAS NOT ATTACHED PROPERLY. THERE WAS A GAP IN THE LEAFLET JUST BEYOND ITS ATTACHMENT. THERE WAS NO TEAR IN THE LEAFLET OR CUSP. LEAFLET TISSUE HAD NOT BEEN MANUALLY MANIPULATED OR HANDLED WITH ANY UNPROTECTED FORCEPS OR SHARP INSTRUMENTS THE VALVE WAS REMOVED AND REPLACED WITH ANOTHER 21MM EPIC PLUS VALVE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND IS REPORTED TO BE STABLE. THERE WERE NO PATIENT CONSEQUENCES AND NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18086060 ↗
• InjuryOct 26, 2023Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM EPIC PLUS SUPRA WAS IMPLANTED IN A PATIENT. ON (B)(6) 2023, THE DEVICE WAS EXPLANTED DUE TO A PARAVALVULAR LEAK OF 8 MMHG AND AVERAGE GRADIENT OF 35 MMHG. A 19MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS IMPLANTED AS A REPLACEMENT. POST IMPLANT, IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE CAUSE AND DATE OF THE DEATH IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18014074 ↗
• DeathSep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DAY IN (B)(6) 2022, A 21MM EPIC TISSUE HEART VALVE WAS IMPLANTED IN A PATIENT. AFTER A YEAR ON AN UNKNOWN DATE, THE PATIENT HAD THROMBOSIS OF THE VALVE THAT CAUSED ITS DETERIORATION WHICH WAS SEEN ON CORONARY ANGIOTAC AND ECHOCARDIOGRAM. THE PATIENT DID NOT HAVE ANY HEMATOLOGIC DISORDERS OR SYSTEMIC ILLNESS THAT COULD CONTRIBUTE TO A HYPERCOAGULABILITY. ON (B)(6) 2023 AN EXPLANT PROCEDURE OF THE DEVICE WAS CARRIED OUT AND A 21MM EPIC PLUS SUPRA WAS IMPLANTED AS A REPLACEMENT. IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO VENTRICULAR DYSFUNCTION POST EXPLANT.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 17703892 ↗
• MalfunctionAug 22, 2023Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM EPIC PLUS SUPRA AORTIC VALVE WAS CHOSEN FOR IMPLANT. AFTER IMPLANTING THE VALVE, THE PHYSICIAN NOTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) THE VALVE "APPEARED TO LEAK" AND HAD DIFFICULTLY CLOSING. A DECISION WAS MADE TO EXPLANT THE VALVE. THE 21MM EPIC PLUS SUPRA AORTIC VALVE WAS REPLACED WITH A 19MM EPIC PLUS SUPRA AORTIC VALVE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17599042 ↗
• MalfunctionNov 29, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, A 21MM EPIC PLUS SUPRA AORTIC VALVE WAS IMPLANTED INTO A PATIENT. ON (B)(6) 2022, THE PATIENT HAD AN ECHOCARDIOGRAM, AND A GRADIENT OF 34MMHG WAS DISCOVERED. THE VALVE REMAINS IMPLANTED. THE PATIENT'S STATUS AT THE TIME OF REPORT WAS NOTED AS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 15880781 ↗