CoreValve Evolut RRecalls & reported problems across all models
Medtronic Corevalve LLC · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,753
- Deaths reported
- 115
- Injuries reported
- 1,535
- Recalls
- 0
We found 8 models of CoreValve Evolut R by Medtronic Corevalve LLC in the FDA's device registry (GUDID). Together they are named in 1,753 adverse event reports in the FDA's MAUDE database, received between Nov 30, 2016 and Sep 30, 2026 — classified as 115 deaths, 1,535 injuries, 103 malfunctions.
The most frequently reported specific device problem is “Perivalvular Leak” (490 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 R problems
Device problems
- Perivalvular Leak490
- Adverse Event Without Identified Device or Use Problem480
- Device Dislodged or Dislocated329
- Patient Device Interaction Problem213
- Intravalvular regurgitation203
- Insufficient Device Problem Information190
- Device Stenosis163
- Gradient Increase148
Patient problems
- No Known Impact Or Consequence To Patient387
- Aortic Valve Insufficiency/ Regurgitation235
- Non specific EKG/ECG Changes183
- Valvular Insufficiency/ Regurgitation158
- Complete Heart Block138
- Aortic Valve Stenosis124
- Insufficient Information104
- No Clinical Signs, Symptoms or Conditions100
CoreValve Evolut R models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CoreValve™ Evolut™ R EVOLUTR-34-USAortic valve, prosthesis, percutaneously delivered24 deaths442 reports
- CoreValve™ Evolut™ R EVOLUTR-34-USAortic valve, prosthesis, percutaneously delivered21 deaths436 reports
- CoreValve™ Evolut™ R EVOLUTR-29-USAortic valve, prosthesis, percutaneously delivered22 deaths300 reports
- CoreValve™ Evolut™ R EVOLUTR-26-USAortic valve, prosthesis, percutaneously delivered11 deaths187 reports
- CoreValve™ Evolut™ R EVOLUTR-26-USAortic valve, prosthesis, percutaneously delivered10 deaths107 reports
- CoreValve™ Evolut™ R EVOLUTR-23-USAortic valve, prosthesis, percutaneously delivered15 deaths105 reports
- CoreValve™ Evolut™ R EVOLUTR-23-USAortic valve, prosthesis, percutaneously delivered6 deaths104 reports
- CoreValve™ Evolut™ R EVOLUTR-29-USAortic valve, prosthesis, percutaneously delivered6 deaths72 reports
Recent CoreValve Evolut R adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Calcified; Gradient Increase; Device Stenosis
It was reported that approximately 7 years and 7 months following the implant of a transcatheter aortic valve, the valve failed due to aortic stenosis, a mean gradient of 55 millimeters of mercury (mmHg) and calcification of the valve. The patient suffered from progressive dyspnea and fatigue as a result. The patient was screened for a possible valve-in-valve procedure.
Patient problems: Aortic Valve Stenosis; Calcium Deposits/Calcification; Dyspnea; Fatigue; Transvalvular Pressure Gradient Increased
MAUDE report 50949370 ↗InjurySep 29, 2026Insufficient Device Problem Information; Unspecified Valve Regurgitation
Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information
MAUDE report 50934459 ↗MalfunctionSep 28, 2026Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918258 ↗MalfunctionSep 17, 2026Device Stenosis
Patient problems: Aortic Valve Stenosis
MAUDE report 50808709 ↗InjurySep 17, 2026Patient Device Interaction Problem; Intravalvular regurgitation; Unspecified Valve Regurgitation
It was reported that approximately 7 years and 3 months following the implant of a transcatheter aortic valve, the valve failed due to moderate to severe aortic insufficiency. The patient suffered from hemodynamic instability as a result. It was also noted that the patient is suffering from mitral regurgitation of unspecified severity. It was noted that the patient's stage IV kidney disease, the patient's calcified anatomy, and the initial depth of implant may be contributing factors to the aortic insufficiency. The patient is currently being evaluated for potential treatment options including a valve-in-valve procedure or an explant/surgical aortic valve implant.
Patient problems: Hemodynamic instability; Mitral Valve Insufficiency/ Regurgitation; Valvular Insufficiency/ Regurgitation
MAUDE report 50806402 ↗MalfunctionSep 4, 2026Perivalvular Leak; Insufficient Device Problem Information; Thickening of Material
Additional information was received which indicated approximately 6 years and 11 months following the valve implant, at the 7-year follow-up clinic visit a transthoracic echocardiogram (TTE) showed suspect mild to moderate posterior paravalvular regurgitation. The physician indicated this was defined as not serious. A computed tomography angiogram (CTA) was ordered to further evaluate the valve. The CT identified grade-1 hypoattenuated leaflet thickening (HALT). Patient symptoms were not reported. Treatment was not required. The event was reported as resolving with a causal relationship to the transcatheter valve.
Patient problems: Insufficient Information
MAUDE report 50616098 ↗MalfunctionSep 4, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50611772 ↗InjuryAug 17, 2026Perivalvular Leak; Device Stenosis; Intravalvular regurgitation
Additional information was received that the patient was admitted to the hospital two days prior to the valve-in-valve procedure and discharged four days later.
Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Valvular Insufficiency/ Regurgitation
MAUDE report 50278043 ↗InjuryAug 7, 2026Patient Device Interaction Problem; Unspecified Valve Regurgitation
It was reported that approximately 8 years following the implant of a transcatheter aortic valve, the valve failed due to severe aortic insufficiency. The patient suffered hemodynamic instability and congestive heart failure (CHF) as a result. It was reported that the patient was planned for a valve-in-valve with a non-Medtronic valve on the evening of the onset of the valve failure.
Patient problems: Heart Failure/Congestive Heart Failure; Hemodynamic instability; Valvular Insufficiency/ Regurgitation
MAUDE report 50178188 ↗InjuryAug 6, 2026Device Stenosis
It was reported that approximately 9 years and 4 months following the implant of a transcatheter aortic valve, the valve failed due to aortic stenosis.
Patient problems: Aortic Valve Stenosis
MAUDE report 50160360 ↗InjuryJul 31, 2026Patient Device Interaction Problem
It was reported that approximately 5 days following the implant of a transcatheter aortic valve, a permanent pacemaker was implanted for an atrio-ventricular (AV) block of unspecified severity.
Patient problems: Non specific EKG/ECG Changes
MAUDE report 50105619 ↗InjuryJul 30, 2026Perivalvular Leak; Patient Device Interaction Problem
It was reported that approximately 6 years and 7 months following the implant of a transcatheter aortic valve, the valve failed due to severe paravalvular leak (PVL). As a result, the patient was hospitalized due to congestive heart failure (CHF), low grade cardiogenic shock, hypotension, global hypokinesis, and an ejection fraction of 25.3%. The patient was administered norepinephrine to treat the hypotension.
Patient problems: Cardiogenic Shock; Heart Failure/Congestive Heart Failure; Low Blood Pressure/ Hypotension; Valvular Insufficiency/ Regurgitation
MAUDE report 50082932 ↗InjuryJul 30, 2026Device Stenosis
It was reported that 9 years and 11 months following implantation of a transcatheter aortic valve into a previously implanted surgical valve, aortic stenosis was identified and the patient was hospitalized.
Patient problems: Aortic Valve Stenosis
MAUDE report 50082534 ↗InjuryJul 28, 2026Insufficient Device Problem Information
It was reported that approximately 7 years and 7 months following the implant of a transcatheter aortic valve, the valve was explanted. Subsequently, a surgical aortic valve was implanted.
Patient problems: Insufficient Information
MAUDE report 50063751 ↗DeathJul 20, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 8 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE PATIENT DIED DUE TO AN UNSPECIFIED CAUSE.
Patient problems: Insufficient Information
MAUDE report 25882248 ↗
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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