CoreValve Evolut PRORecalls & reported problems across all models
Medtronic Corevalve LLC · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,421
- Deaths reported
- 89
- Injuries reported
- 1,176
- Recalls
- 0
We found 6 models of CoreValve Evolut PRO by Medtronic Corevalve LLC in the FDA's device registry (GUDID). Together they are named in 1,421 adverse event reports in the FDA's MAUDE database, received between Apr 26, 2017 and Sep 29, 2026 — classified as 89 deaths, 1,176 injuries, 156 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (359 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 PRO problems
Device problems
- Adverse Event Without Identified Device or Use Problem380
- Device Dislodged or Dislocated359
- Perivalvular Leak288
- Patient Device Interaction Problem212
- Intravalvular regurgitation166
- Insufficient Device Problem Information161
- Device Stenosis156
- Gradient Increase115
Patient problems
- No Known Impact Or Consequence To Patient228
- No Clinical Signs, Symptoms or Conditions178
- Aortic Valve Insufficiency/ Regurgitation176
- Non specific EKG/ECG Changes162
- Valvular Insufficiency/ Regurgitation144
- Complete Heart Block131
- Aortic Valve Stenosis104
- Heart Block74
CoreValve Evolut PRO models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CoreValve™ Evolut™ PRO EVOLUTPRO-29-USAortic valve, prosthesis, percutaneously delivered30 deaths596 reports
- CoreValve™ Evolut™ PRO EVOLUTPRO-26-USAortic valve, prosthesis, percutaneously delivered26 deaths305 reports
- CoreValve™ Evolut™ PRO EVOLUTPRO-29-USAortic valve, prosthesis, percutaneously delivered17 deaths276 reports
- CoreValve™ Evolut™ PRO EVOLUTPRO-26-USAortic valve, prosthesis, percutaneously delivered10 deaths164 reports
- CoreValve™ Evolut™ PRO EVOLUTPRO-23-USAortic valve, prosthesis, percutaneously delivered4 deaths55 reports
- CoreValve™ Evolut™ PRO EVOLUTPRO-23-USAortic valve, prosthesis, percutaneously delivered2 deaths25 reports
Recent CoreValve Evolut PRO adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Patient Device Interaction Problem; Device Stenosis
Patient problems: Aortic Valve Stenosis; Heart Failure/Congestive Heart Failure
MAUDE report 50936820 ↗InjurySep 28, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50923972 ↗MalfunctionSep 23, 2026Gradient Increase; Device Stenosis; Unspecified Valve Regurgitation
It was reported that approximately 7 years and 11 months following the implant of a transcatheter aortic valve, the valve failed due to aortic stenosis and a mean pressure gradient of 53 millimeters of mercury (mmHg). No patient complications were reported as a result of this event.
Patient problems: Aortic Valve Stenosis; Transvalvular Pressure Gradient Increased; Valvular Insufficiency/ Regurgitation
MAUDE report 50873660 ↗MalfunctionSep 22, 2026Perivalvular Leak; Insufficient Device Problem Information
It was reported that approximately 6 years and 8 months following the implant of a transcatheter aortic valve, the valve failed due to unspecified degenerative changes. Trace paravalvular leak (PVL) and dyspnea on exertion were also observed. Per the physician, the initial depth of implant contributed to this event. No patient complications were reported as a result of this event.
Patient problems: Dyspnea; Valvular Insufficiency/ Regurgitation
MAUDE report 50858734 ↗InjurySep 21, 2026Gradient Increase; Patient Device Interaction Problem; Intravalvular regurgitation
Patient problems: Aortic Valve Insufficiency/ Regurgitation; Heart Failure/Congestive Heart Failure; Hemodynamic instability
MAUDE report 50847547 ↗InjurySep 21, 2026Device Stenosis
It was reported that approximately eight years and one month following the implant of an Evolut PRO transcatheter valve, stenosis was identified. It was noted that an intervention was required, and the patient was undergoing evaluation to determine a treatment plan for the valve stenosis.
Patient problems: Aortic Valve Stenosis
MAUDE report 50839178 ↗InjurySep 18, 2026Intravalvular regurgitation
Patient problems: Aortic Valve Insufficiency/ Regurgitation
MAUDE report 50829256 ↗MalfunctionSep 18, 2026Intravalvular regurgitation
Patient problems: Aortic Valve Insufficiency/ Regurgitation; No Clinical Signs, Symptoms or Conditions
MAUDE report 50826031 ↗InjuryAug 30, 2026Perivalvular Leak; Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation
Patient problems: Aortic Valve Insufficiency/ Regurgitation; Heart Failure/Congestive Heart Failure; Insufficient Information; Valvular Insufficiency/ Regurgitation
MAUDE report 50512954 ↗MalfunctionAug 26, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50461346 ↗InjuryAug 7, 2026Perivalvular Leak
It was reported that following the implant of a transcatheter aortic valve, moderate paravalvular leak (PVL) was identified. Subsequently, a second valve was implanted valve-in-valve.
Patient problems: Valvular Insufficiency/ Regurgitation
MAUDE report 50174911 ↗InjuryAug 5, 2026Intravalvular regurgitation; Unspecified Valve Regurgitation
It was reported that approximately 7 years following the implant of a transcatheter aortic valve, the valve failed due to regurgitation of unspecified type and severity. It was noted that a valve-in-valve procedure will be required to treat the regurgitation.
Patient problems: Aortic Valve Insufficiency/ Regurgitation; Valvular Insufficiency/ Regurgitation
MAUDE report 50145564 ↗InjuryJul 30, 2026Intravalvular regurgitation
It was reported that approximately 7 years and 7 months following the implant of a transcatheter aortic valve, the valve failed due to severe central aortic regurgitation. The patient was scheduled for a valve-in-valve replacement for the same day as the onset of the regurgitation.
Patient problems: Aortic Valve Insufficiency/ Regurgitation
MAUDE report 50086518 ↗InjuryJul 30, 2026Insufficient Device Problem Information; Intravalvular regurgitation
It was reported that following the implant of a transcatheter aortic valve, a second valve was implanted valve-in-valve for an unspecified reason. Following the implant of the second valve, it was inactivated for an unspecified reason.
Patient problems: Aortic Valve Insufficiency/ Regurgitation; Foreign Body In Patient; Insufficient Information
MAUDE report 50086494 ↗InjuryJul 27, 2026Patient Device Interaction Problem
It was reported that during the attempted implant of a transcatheter aortic valve, upon deployment of the valve to 80%, ventricular fibrillation was observed, secondary to coronary vasospasms. Medication was administered, however the medication was unsuccessful. Subsequently, the patient was referred to surgery.
Patient problems: Vasospasm; Ventricular Fibrillation
MAUDE report 50011282 ↗
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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