CoreValve EvolutRecalls & reported problems across all models
Medtronic Corevalve LLC · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 149
- Deaths reported
- 3
- Injuries reported
- 133
- Recalls
- 0
We found 9 models of CoreValve Evolut by Medtronic Corevalve LLC in the FDA's device registry (GUDID). Together they are named in 149 adverse event reports in the FDA's MAUDE database, received between Jun 22, 2015 and May 15, 2026 — classified as 3 deaths, 133 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (28 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
Reports received per month, all models
Most reported CoreValve Evolut problems
Device problems
- Adverse Event Without Identified Device or Use Problem58
- Insufficient Device Problem Information28
- Patient Device Interaction Problem22
- Device Stenosis21
- Perivalvular Leak20
- Gradient Increase17
- Intravalvular regurgitation16
- Calcified8
Patient problems
- Aortic Valve Stenosis26
- Non specific EKG/ECG Changes23
- Aortic Valve Insufficiency/ Regurgitation22
- No Clinical Signs, Symptoms or Conditions16
- Insufficient Information15
- Dyspnea13
- Complete Heart Block10
- No Known Impact Or Consequence To Patient10
CoreValve Evolut models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CoreValve™ Evolut™ MCS-P3-31-AOA-USAortic valve, prosthesis, percutaneously delivered65 reports
- CoreValve™ Evolut™ MCS-P3-29-AOA-USAortic valve, prosthesis, percutaneously delivered24 reports
- CoreValve™ Evolut™ MCS-P3-26-AOA-USAortic valve, prosthesis, percutaneously delivered19 reports
- CoreValve™ Evolut™ MCS-P3-29-AOAAortic valve, prosthesis, percutaneously delivered2 deaths15 reports
- CoreValve™ Evolut™ MCS-P3-31-AOAAortic valve, prosthesis, percutaneously delivered13 reports
- CoreValve™ Evolut™ MCS-P3-26-AOAAortic valve, prosthesis, percutaneously delivered5 reports
- CoreValve™ Evolut™ MCS-P4-23-AOA-USAortic valve, prosthesis, percutaneously delivered5 reports
- CoreValve™ Evolut™ MCS-P4-23-AOAAortic valve, prosthesis, percutaneously delivered1 death2 reports
- CoreValve™ Evolut™ MCS-P3-29-AOA-USAortic valve, prosthesis, percutaneously delivered1 report
Recent CoreValve Evolut adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 15, 2026Patient Device Interaction Problem; Device Stenosis
IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 4 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO STENOSIS. THE PATIENT WAS HOSPITALIZED AND SUFFERED FROM HEART FAILURE AND HEMODYNAMIC INSTABILITY AS A RESULT. SUBSEQUENTLY, THE VALVE WAS EXPLANTED, AND A SURGICAL AORTIC VALVE WAS IMPLANTED.
Patient problems: Aortic Valve Stenosis; Heart Failure/Congestive Heart Failure; Hemodynamic instability
MAUDE report 25191616 ↗MalfunctionApr 10, 2026Calcified; Device Stenosis
IT WAS REPORTED THAT 11 YEARS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, VALVULAR STENOSIS AND CALCIFICATION WAS IDENTIFIED.
Patient problems: Aortic Valve Stenosis; Calcium Deposits/Calcification
MAUDE report 24842053 ↗InjuryMar 23, 2026Patient Device Interaction Problem
INFORMATION WAS RECEIVED WHICH INDICATED THAT APPROXIMATELY 4.5 MONTHS FOLLOWING THE IMPLANT OF THE TRANSCATHETER BIOPROSTHETIC AORTIC VALVE A CARDIAC RESYNCHRONIZATION DEFIBRILLATOR (CRT-D) WAS IMPLANTED DUE TO A LOW EJECTION FRACTION, DYSSYNCHRONY, AND A WIDE QRS COMPLEX.
Patient problems: Cardiovascular Dysfunction/Insufficiency; Non specific EKG/ECG Changes
MAUDE report 24662884 ↗MalfunctionMar 20, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT APPROXIMATELY 10 YEARS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO AN UNSPECIFIED CAUSE. THE PATIENT IS BEING EVALUATED FOR POTENTIAL TREATMENT OPTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24650479 ↗InjuryMar 17, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT APPROXIMATELY 10 YEARS AND 3 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE WAS INACTIVATED FOR AN UNSPECIFIED REASON. SUBSEQUENTLY, A SECOND VALVE WAS IMPLANTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24617743 ↗InjuryFeb 12, 2026Patient Device Interaction Problem; Intravalvular regurgitation
IT WAS REPORTED THAT APPROXIMATELY 11 YEARS AND 9 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO SEVERE CENTRAL AORTIC REGURGITATION. THE PATIENT SUFFERED EXACERBATION OF CONGESTIVE HEART FAILURE (CHF) AS A RESULT, LEADING TO SIDE EFFECTS OF SHORTNESS OF BREATH AND SWELLING.
Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea; Heart Failure/Congestive Heart Failure; Swelling/ Edema
MAUDE report 24323567 ↗InjuryJan 30, 2026Insufficient Device Problem Information
IT WAS REPORTED APPROXIMATELY 8 YEARS AND 1 MONTH FOLLOWING THE IMPLANT OF THIS TRANSCATHETER AORTIC VALVE, THE VALVE WAS EXPLANTED FOR AN UNKNOWN REASON. SUBSEQUENTLY, A SURGICAL TISSUE VALVE WAS IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 24225398 ↗InjuryJan 27, 2026Perivalvular Leak; Patient Device Interaction Problem; Intravalvular regurgitation
IT WAS REPORTED THAT 11 YEARS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, CENTRAL REGURGITATION OF UNKNOWN SEVERITY WAS IDENTIFIED. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED AND EXPERIENCED SYMPTOMS OF HEART FAILURE.
Patient problems: Aortic Valve Insufficiency/ Regurgitation; Heart Failure/Congestive Heart Failure; Thrombosis/Thrombus
MAUDE report 24189249 ↗InjuryJan 26, 2026Device Stenosis
ADDITIONAL INFORMATION WAS RECEIVED THAT A NON-MEDTRONIC VALVE WAS IMPLANTED VALVE-IN-VALVE AS TREATMENT FOR THE STENOSIS.
Patient problems: Valvular Stenosis
MAUDE report 24183476 ↗MalfunctionNov 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT APPROXIMATELY 10 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, UNSPECIFIED VALVE FAILURE WAS OBSERVED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23631485 ↗InjuryOct 29, 2025Gradient Increase; Device Stenosis; Gradient Increase; Device Stenosis
IT WAS REPORTED APPROXIMATELY TEN AND A HALF YEARS FOLLOWING IMPLANT OF A MEDTRONIC TRANSCATHETER AORTIC BIOPROSTHETIC VALVE (TAV), VALVE FAILURE WAS NOTED. THE PRIMARY MODE OF VALVE FAILURE WAS STRUCTURAL VALVE DETERIORATION; PREDOMINANT AORTIC STENOSIS WITH SEVERE HEMODYNAMIC VALVE DETERIORATION. THIS WAS CHARACTERIZED BY AN INCREASE IN MEAN GRADIENT >=20MM HG FROM BASELINE AND MEAN GRADIENT >=30MM HG. THE PATIENT WAS ENROLLED IN A CLINICAL STUDY WITH EXISTING, BASELINE VALVE FAILURE TO DETERMINE WHETHER A REDO-TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE, TAV-IN-TAV, WAS APPROPRIATE. APPROXIMATELY TWO MONTHS, THREE WEEKS AFTER THE VALVE FAILURE WAS NOTED, THE PATIENT WAS TREATED WITH RE-INTERVENTION FOR THE FAILED TAV. A NON-MEDTRONIC (EDWARDS) VALVE WAS IMPLANTED WITHIN THE MEDTRONIC TAV. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Dyspnea; Fatigue; No Clinical Signs, Symptoms or Conditions; Peripheral Edema
MAUDE report 23417842 ↗InjuryAug 28, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, VENTRICULAR FIBRILLATION WAS REPORTED AND CARDIOVERSION WAS PERFORMED ONCE. FOLLOWING THE VALVE IMPLANT PROCEDURE, LEFT BUNDLE BRANCH BLOCK (LBBB) AND SINUS BRADYCARDIA WERE NOTED. A TEMPORARY PACING WIRE WAS PLACED AND MEDICATION WAS ADJUSTED. HYPOTENSION WAS REPORTED DUE TO VOLUME DEPLETION AND PRESSORS WERE PRESCRIBED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS REPORTED THAT NO TREATMENT WAS PROVIDED FOR THE LBBB. PER THE PHYSICIAN, THE LBBB WAS RELATED TO THE VALVE AND VALVE IMPLANT PROCEDURE. APPROXIMATELY SIX MONTHS FOLLOWING ONSET, THE LBBB RESOLVED, WITHOUT SEQUELAE. ADDITIONAL INFORMATION WAS REPORTED THAT A PERMANENT PACEMAKER WAS IMPLANTED THREE DAYS FOLLOWING THE IMPLANT OF THE VALVE FOR BRADYCARDIA. BRADYCARDIA RESOLVED WITH NO SEQUELAE ONE DAY FOLLOWING THE IMPLANT OF THE PERMANENT PACEMAKER. PER THE PHYSICIAN, THE BRADYCARDIA EVENT WAS RELATED TO THE VALVE AND THE VALVE IMPLANT PROCEDURE.
Patient problems: Bradycardia; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes; Ventricular Fibrillation
MAUDE report 22915018 ↗InjuryAug 1, 2025Gradient Increase; Gradient Increase
ADDITIONAL INFORMATION RECEIVED INDICATED THAT EIGHT DAYS FOLLOWING THE IDENTIFICATION OF THE FAILED VALVE, A REDO VALVE-IN-VALVE PROCEDURE OCCURRED AND REQUIRED HOSPITALIZATION. THE SECOND VALVE IMPLANTED WAS A NON-MEDTRONIC AORTIC VALVE. THE PATIENT WAS DISCHARGED TWO DAYS AFTER THE VALVE-IN-VALVE PROCEDURE.
Patient problems: Transvalvular Pressure Gradient Increased
MAUDE report 22687427 ↗MalfunctionJul 25, 2025Device Stenosis; Device Stenosis
IT WAS REPORTED THAT APPROXIMATELY 10 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO AORTIC STENOSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Aortic Valve Stenosis
MAUDE report 22611125 ↗InjuryJun 13, 2025Fluid/Blood Leak; Gradient Increase; Perivalvular Leak; Fluid/Blood Leak; Gradient Increase; Perivalvular Leak
ADDITIONAL INFORMATION RECEIVED INDICATED THAT UNSPECIFIED REGURGITATION WAS ALSO PRESENT. AN UNSPECIFIED VALVE INTERVENTION OCCURRED APPROXIMATELY 2 MONTHS FOLLOWING ONSET OF THIS EVENT. HOSPITALIZATION WAS REQUIRED.
Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea; Transvalvular Pressure Gradient Increased
MAUDE report 22202491 ↗
Other Medtronic Corevalve LLC products
All Medtronic Corevalve LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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