EpicRecalls & reported problems across all models

We found 26 models of Epic by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 271 adverse event reports in the FDA's MAUDE database, received between Jan 5, 2017 and Sep 25, 2026 — classified as 23 deaths, 165 injuries, 83 malfunctions.

The most frequently reported specific device problem is “Incomplete Coaptation” (43 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Epic problems

Epic models

26 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Epic™ E200-31M

  heart-valve, non-allograft tissue
  2 deaths30 reports
• Epic™ E200-29M

  heart-valve, non-allograft tissue
  2 deaths26 reports
• Epic™ E200-33M

  heart-valve, non-allograft tissue
  25 reports
• Epic™ E200-27M

  heart-valve, non-allograft tissue
  1 death20 reports
• Epic™ EMAX-25

  heart-valve, non-allograft tissue
  20 reports
• Epic™ ESP200-21

  heart-valve, non-allograft tissue
  2 deaths17 reports
• Epic™ E100-29M-00

  heart-valve, non-allograft tissue
  4 deaths15 reports
• Epic™ E100-31M-00

  heart-valve, non-allograft tissue
  2 deaths15 reports
• Epic™ ESP200-23

  heart-valve, non-allograft tissue
  2 deaths14 reports
• Epic™ EMAX-21

  heart-valve, non-allograft tissue
  2 deaths13 reports
• Epic™ E100-33M-00

  heart-valve, non-allograft tissue
  1 death12 reports
• Epic™ E200-25M

  heart-valve, non-allograft tissue
  1 death10 reports
• Epic™ ESP200-19

  heart-valve, non-allograft tissue
  1 death10 reports
• Epic™ E100-27M-00

  heart-valve, non-allograft tissue
  1 death9 reports
• Epic™ EMAX-23

  heart-valve, non-allograft tissue
  8 reports
• Epic™ ESP200-25

  heart-valve, non-allograft tissue
  7 reports
• Epic™ EMAX-19

  heart-valve, non-allograft tissue
  1 death6 reports
• Epic™ E100-25M-00

  heart-valve, non-allograft tissue
  1 death2 reports
• Epic™ ESP100-23-00

  heart-valve, non-allograft tissue
  2 reports
• Epic™ ESP100-25-00

  heart-valve, non-allograft tissue
  2 reports
• Epic™ E200-23A

  heart-valve, non-allograft tissue
  2 reports
• Epic™ ESP200-27

  heart-valve, non-allograft tissue
  2 reports
• Epic™ E100-23A-00

  heart-valve, non-allograft tissue
  1 report
• Epic™ E100-27A-00

  heart-valve, non-allograft tissue
  1 report
• Epic™ ESP100-21-00

  heart-valve, non-allograft tissue
  1 report
• Epic™ E200-21A

  heart-valve, non-allograft tissue
  1 report

Recent Epic adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  CRD_1032 - SH Device Registry, Patient Site ID: (b)(6).It was reported that on (b)(6) 2026, a 31mm Epic Plus Mitral Valve was chosen for implant. Post-procedure on (b)(6) 2026, patient experienced atrial fibrillation as well as repeated bradycardic episodes with asymptomatic pauses on 13 August 2026. Atrial fibrillation transitioned to a brief episode of asystole on 15 August 2026. There was also a pause on bradycardia followed by tachycardic conduction. Patient symptoms were consistent with sick sinus syndrome. Patient was administered medication and underwent two sessions of electrical cardioversions with no result. No further significant pauses occurred until discharge. On 19 August 2026, patient had an ejection fraction of 35% and subsequently received a life vest for three months. It was also reported patient experienced a urinary tract infection on (b)(6) 2026 and was treated with antibiotics same day.

  Patient problems: Atrial Fibrillation; Bradycardia; Cardiac Arrest; Heart Failure/Congestive Heart Failure; Tachycardia; Unspecified Infection

  MAUDE report 50897780 ↗
• 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 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  (b)(4) - SH Device Registry, Patient Site ID: (b)(6).It was reported that on (b)(6) 2026, a 33mm Epic Plus Mitral Valve was chosen for redo-surgical mitral valve replacement. Post-intervention, patient experienced pleural effusion, requiring a pleural tap on (b)(6) 2026, draining 700 mL of serous fluid, and received two units of red packed blood cells transfusion. Patient also developed subcutaneous emphysema post-intervention, subsequently, bilateral chest tubes were inserted on (b)(6) 2026. It was later reported on 31 May 2026 that patient experienced acute coronary syndrome in a constellation with non-ST elevation myocardial infarction (NSTEMI). Patient had elevated troponin levels. A coronary angiography performed on (b)(6) 2026 revealed no hemodynamically significant stenoses.

  Patient problems: Cardiac Enzyme Elevation; Myocardial Infarction; Pleural Effusion; Unspecified Tissue Injury

  MAUDE report 50897587 ↗
• InjurySep 25, 2026Patient-Device Incompatibility

  CRD_1032 - SH Device Registry, Patient Site ID: (b)(6), (b)(6).It was reported that on (b)(6) 2024, a 33mm Epic Plus Mitral Valve was chosen for implant. It was later reported on (b)(6) 2026, patient had recurrent valvular endocarditis. A decision was made to perform redo-surgical mitral valve replacement with a second 33mm Epic Plus Mitral Valve on (b)(6) 2026.

  Patient problems: Endocarditis

  MAUDE report 50897526 ↗
• MalfunctionSep 18, 2026Perivalvular Leak

  It was reported that on (b)(6) 2026, a 27mm Epic Plus Mitral Valve was implanted in the mitral valve position. Due to perivalvar leak (PVL), it was reimplanted, but no improvement was achieved. Subsequently, a 25mm Epic Plus Mitral Valve was implanted, and the procedure was completed. The patient was reported stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817186 ↗
• InjurySep 15, 2026Patient-Device Incompatibility; Patient Device Interaction Problem; Device Stenosis

  It was reported that on (b)(6) 2025, a 23mm Epic Plus Supra Valve was implanted in the patient. At the one-year postoperative follow-up examination, no abnormalities were detected on echocardiography (ECHO). On (b)(6) 2026, the patient presented with severe aortic stenosis (AS). A routine follow-up ECHO, and computed tomography (CT) examination confirmed a presence of thrombus. The valve got explanted and a new 21mm non-Abbott valve was implanted. The explanted device showed with pannus formation and thrombus on all valve leaflets. The patient was reported stable.

  Patient problems: Aortic Valve Stenosis; Thrombosis/Thrombus

  MAUDE report 50775063 ↗
• MalfunctionSep 14, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50762763 ↗
• MalfunctionSep 14, 2026Incomplete Coaptation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50762694 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  CRD (b)(4) Device Registry, Patient Site ID: US0202 - 3851 (b)(6).It was reported that on (b)(6) 2026, a 25mm Epic Max Aortic Valve was chosen for implant. During procedure, patient became hypotensive. Post-procedure, patient experienced bleeding from aortic patch and subsequently received blood product transfusions and protamine. Medication was also administered to treat continued hypotension. It was then reported on (b)(6) 2026, patient complained of increased chest pain. Electrocardiogram reported new onset atrial fibrillation, though patient remained hemodynamically stable. Medication, amiodarone, was administered and patient converted back to normal sinus rhythm. The patient's post-operative course included intermittent in and out atrial fibrillation and a self-limited run of ventricular tachycardia on (b)(6) 2026. Medication was adjusted and metoprolol was increased and replete electrolytes. Patient was discharged home in normal sinus rhythm.

  Patient problems: Angina; Atrial Fibrillation; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 50734352 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  CRD (b)(4)Device Registry, Patient Site ID: (b)(6).It was reported that on (b)(6) 2026, a 25mm Epic Max Aortic Valve was chosen for implant. Intraoperatively, patient experienced multiple episodes of ventricular fibrillation when coming off of cardiopulmonary bypass. Defibrillation was required and patient was put back on bypass. Patient continued to have a few small runs ventricular fibrillation but were self-limited. Post-procedure, patient experienced a bleeding event and over 200cc of fluid drained from chest tube in first hour. Patient was also hypotensive. Medication and 2 units of cryoprecipitate were administered. It was later reported on 25 April 2026, patient cardiac rhythm was going in and out of atrial fibrillation with heart rate in the 90-120 bpm, though remained asymptomatic. Patient self-converted back to normal sinus rhythm and intravenous medication was administered.

  Patient problems: Atrial Fibrillation; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Ventricular Fibrillation

  MAUDE report 50734262 ↗
• 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 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  CRD (b)(4) Device Registry, Patient Site ID: (b)(6).It was reported that on (b)(6) 2026, a 21mm Epic Max Aortic Valve was chosen for implant. The patient also received a 25mm Epic Plus Mitral Valve for a concomitant double valve replacement procedure. The procedure was uneventful. Following protamine administration, patient developed severe left ventricular dysfunction and was placed on extracorporeal membranous oxygenation (ECMO). It was then reported on (b)(6) 2026, patient presented with respiratory failure of multifactorial origin, initially secondary to acute pulmonary edema and subsequently secondary to ventilator-associated pneumonia. A tracheostomy was performed and patient was administered antibiotics. Patient was weaned off of ECMO on post-op day 8, (b)(6) 2026. On (b)(6) 2026, patient experienced a slow awakening, An urgent computed tomography (CT) scan revealed findings consistent with ischemic stroke of subacute evolution in the territory of the right posterior cerebral artery. A magnetic resonance imaging (MRF) performed 5 days later showed signs of hemorrhagic transformation. It was reported the patient had a good neurological outcome and was discharged with the need

  Patient problems: Arrhythmia; Pulmonary Edema; Respiratory Insufficiency; Stroke/CVA

  MAUDE report 50733677 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  CRD_1032 - SH Device Registry, Patient Site ID: (b)(6) It was reported that on (b)(6) 2026, a 25mm Epic Max Aortic Valve was chosen for implant. It was then reported post-procedure that patient became hypotensive and was subsequently administered medication. It was then reported on 28 March 2026, patient experienced atrial fibrillation with complaints of shortness of breath, palpitations, and feeling weak/tired. Patient heart rate was reported in the 90-100s. Patient was subsequently administered medication and converted to normal sinus rhythm. No additional or prolonged hospitalization was required. Patient status was reported discharged.

  Patient problems: Arrhythmia; Atrial Fibrillation; Dyspnea; Fatigue; Low Blood Pressure/ Hypotension

  MAUDE report 50733433 ↗
• InjuryAug 24, 2026Intravalvular regurgitation

  It was reported that on (b)(6) 2022, a 27mm Epic Valve was implanted in the patient. It was reported that on (b)(6) 2026, the patient presented with shortness of breath and an increase in mitral regurgitation (MR) was noted. A redo procedure was scheduled. The excision date is unknown because it was performed at another hospital. The patient is stable and under observation.

  Patient problems: Dyspnea; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 50420817 ↗
• 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 ↗

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