Evolut PRO+Recalls & 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
1 open recall names at least one Evolut PRO+ model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2,532
- Deaths reported
- 232
- Injuries reported
- 1,985
- Recalls
- 1
We found 8 models of Evolut PRO+ by Medtronic Corevalve LLC in the FDA's device registry (GUDID). Together they are named in 2,532 adverse event reports in the FDA's MAUDE database, received between Oct 16, 2019 and Sep 30, 2026 — classified as 232 deaths, 1,985 injuries, 315 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (728 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Evolut PRO+ recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 11, 2021Open, Classified
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Z-2043-2021 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗
Most reported Evolut PRO+ problems
Device problems
- Adverse Event Without Identified Device or Use Problem769
- Device Dislodged or Dislocated728
- Patient Device Interaction Problem522
- Perivalvular Leak429
- Insufficient Device Problem Information217
- Activation Failure187
- Device Stenosis176
- Intravalvular regurgitation155
Patient problems
- No Clinical Signs, Symptoms or Conditions545
- Non specific EKG/ECG Changes439
- Valvular Insufficiency/ Regurgitation399
- Heart Block337
- Aortic Valve Insufficiency/ Regurgitation211
- Low Blood Pressure/ Hypotension178
- No Consequences Or Impact To Patient159
- Insufficient Information138
Evolut PRO+ models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Evolut™ PRO+ EVPROPLUS-29USAortic valve, prosthesis, percutaneously delivered57 deaths869 reports
- Evolut™ PRO+ EVPROPLUS-34USAortic valve, prosthesis, percutaneously delivered43 deaths613 reports
- Evolut™ PRO+ EVPROPLUS-26USAortic valve, prosthesis, percutaneously delivered66 deaths578 reports
- Evolut™ PRO+ D-EVPROP2329USAortic valve, prosthesis, percutaneously delivered1 recall40 deaths281 reports
- Evolut™ PRO+ EVPROPLUS-23USAortic valve, prosthesis, percutaneously delivered17 deaths134 reports
- Evolut™ PRO+ D-EVPROP34USAortic valve, prosthesis, percutaneously delivered1 recall9 deaths54 reports
- Evolut™ PRO+ L-EVPROP2329USAortic valve, prosthesis, percutaneously delivered2 reports
- Evolut™ PRO+ L-EVPROP34USAortic valve, prosthesis, percutaneously delivered1 report
Recent Evolut PRO+ adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
DeathSep 30, 2026Patient Device Interaction Problem; Unspecified Valve Regurgitation
Patient problems: Pulmonary Edema; Valvular Insufficiency/ Regurgitation
MAUDE report 50949854 ↗MalfunctionSep 29, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50936624 ↗MalfunctionSep 29, 2026Gradient Increase; Device Stenosis
Patient problems: Aortic Valve Stenosis; Insufficient Information; Transvalvular Pressure Gradient Increased
MAUDE report 50935308 ↗MalfunctionSep 28, 2026Device Stenosis
It was reported that approximately 5 years and 6 months following the implant of a transcatheter aortic valve, the valve failed due to severe aortic stenosis. No patient complications were reported as a result of this event.
Patient problems: Aortic Valve Stenosis
MAUDE report 50917341 ↗InjurySep 25, 2026Device Dislodged or Dislocated; Patient Device Interaction Problem
Patient problems: Foreign Body In Patient
MAUDE report 50902647 ↗InjurySep 25, 2026Device Dislodged or Dislocated
Additional information was received that surgical treatment was performed where both valves were explanted and a surgical valve was implanted.
Patient problems: Foreign Body In Patient
MAUDE report 50902616 ↗MalfunctionSep 23, 2026Insufficient Device Problem Information
It was reported that approximately 6 years and 3 months following the implant of a transcatheter aortic valve, the valve failed due to an unspecified cause. No patient complications were reported as a result of this event.
Patient problems: Insufficient Information
MAUDE report 50871881 ↗InjurySep 4, 2026Patient Device Interaction Problem; Intravalvular regurgitation
Patient problems: Aortic Valve Insufficiency/ Regurgitation; Heart Failure/Congestive Heart Failure; Hemodynamic instability
MAUDE report 50616614 ↗MalfunctionSep 3, 2026Device Stenosis; Unspecified Valve Regurgitation
Patient problems: Valvular Insufficiency/ Regurgitation; Valvular Stenosis
MAUDE report 50591682 ↗InjuryAug 30, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50514781 ↗MalfunctionAug 24, 2026Intravalvular regurgitation
Patient problems: Aortic Valve Insufficiency/ Regurgitation
MAUDE report 50410351 ↗MalfunctionAug 10, 2026Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
It was reported that prior to the attempted implant of a transcatheter aortic valve into an indwelling surgical aortic valve (SAV), a pre-implant balloon aortic valvuloplasty (BAV) was performed with a non-Medtronic 26 millimeter (mm) balloon in order to fracture the indwelling SAV frame. Subsequently, a 29 mm valve was attempted, however the valve would not anchor to the SAV. Subsequently, the valve was recaptured into the delivery catheter system (DCS). 4 subsequent deployment attempts and recaptures were performed, however the valve remained unable to anchor to the SAV. Following the 5th attempt, it was decided to withdraw the system from the patient. The valve was upsized to a 34 mm valve, which was subsequently loaded into a new DCS. The 34 mm valve implant was ultimately successful.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50196198 ↗MalfunctionAug 7, 2026Gradient Increase; Patient Device Interaction Problem
Patient problems: Thrombosis/Thrombus; Transvalvular Pressure Gradient Increased
MAUDE report 50177972 ↗InjuryAug 7, 2026Device Stenosis
Additional information was received that a probable implant of a non-Medtronic transcatheter aortic bioprosthetic valve (TAV) was pl anned.
Patient problems: Aortic Valve Stenosis
MAUDE report 50175405 ↗InjuryJul 31, 2026Gradient Increase; Patient Device Interaction Problem; Material Split, Cut or Torn; Intravalvular regurgitation
It was reported that approximately 6 years and 2 months following the implant of a transcatheter aortic valve, the valve failed due to severe central aortic regurgitation and a thrombus on the valve leaflets. The patient suffered from shortness of breath and dyspnea as a result. Subsequently, the valve was explanted, and a surgical aortic valve was implanted.
Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea; Heart Failure/Congestive Heart Failure; Thrombosis/Thrombus
MAUDE report 50103006 ↗
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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