Medtronic Evolut TAVRRecalls & reported problems across all models
Medtronic Corevalve LLC · 45 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Medtronic Evolut TAVR model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 9,600
- Deaths reported
- 785
- Injuries reported
- 6,987
- Recalls
- 1
We found 45 models of Medtronic Evolut TAVR by Medtronic Corevalve LLC in the FDA's device registry (GUDID). Together they are named in 9,600 adverse event reports in the FDA's MAUDE database, received between Jun 22, 2015 and Sep 30, 2026 — classified as 785 deaths, 6,987 injuries, 1,828 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2,442 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
Medtronic Evolut TAVR 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 Medtronic Evolut TAVR problems
Device problems
- Device Dislodged or Dislocated2,442
- Patient Device Interaction Problem2,397
- Adverse Event Without Identified Device or Use Problem2,136
- Perivalvular Leak1,743
- Insufficient Device Problem Information830
- Material Invagination770
- Activation Failure741
- Intravalvular regurgitation668
Patient problems
- No Clinical Signs, Symptoms or Conditions2,498
- Valvular Insufficiency/ Regurgitation1,228
- Non specific EKG/ECG Changes1,164
- Heart Block952
- Aortic Valve Insufficiency/ Regurgitation824
- No Known Impact Or Consequence To Patient649
- Low Blood Pressure/ Hypotension598
- Insufficient Information508
Medtronic Evolut TAVR models
45 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
- CoreValve™ Evolut™ PRO EVOLUTPRO-29-USAortic valve, prosthesis, percutaneously delivered30 deaths596 reports
- Evolut™ PRO+ EVPROPLUS-26USAortic valve, prosthesis, percutaneously delivered66 deaths578 reports
- Evolut™ FX EVOLUTFX-29Aortic valve, prosthesis, percutaneously delivered47 deaths564 reports
- Evolut™ FX EVOLUTFX-34Aortic valve, prosthesis, percutaneously delivered22 deaths563 reports
- Evolut™ FX D-EVOLUTFX-2329Aortic valve, prosthesis, percutaneously delivered79 deaths555 reports
- Evolut™ FX+ EVFXPLUS-29Aortic valve, prosthesis, percutaneously delivered30 deaths465 reports
- CoreValve™ Evolut™ R EVOLUTR-34-USAortic valve, prosthesis, percutaneously delivered24 deaths442 reports
- CoreValve™ Evolut™ R EVOLUTR-34-USAortic valve, prosthesis, percutaneously delivered21 deaths436 reports
- Evolut™ FX EVOLUTFX-26Aortic valve, prosthesis, percutaneously delivered51 deaths382 reports
- Evolut™ FX+ EVFXPLUS-34Aortic valve, prosthesis, percutaneously delivered7 deaths344 reports
- Evolut™ PRO+ D-EVPROP2329USAortic valve, prosthesis, percutaneously delivered1 recall40 deaths281 reports
- CoreValve™ Evolut™ PRO EVOLUTPRO-26-USAortic valve, prosthesis, percutaneously delivered26 deaths305 reports
- CoreValve™ Evolut™ R EVOLUTR-29-USAortic valve, prosthesis, percutaneously delivered22 deaths300 reports
- Evolut™ FX+ EVFXPLUS-26Aortic valve, prosthesis, percutaneously delivered46 deaths279 reports
- CoreValve™ Evolut™ PRO EVOLUTPRO-29-USAortic valve, prosthesis, percutaneously delivered17 deaths276 reports
- Evolut™ FX D-EVOLUTFX-2329Aortic valve, prosthesis, percutaneously delivered25 deaths216 reports
- CoreValve™ Evolut™ R EVOLUTR-26-USAortic valve, prosthesis, percutaneously delivered11 deaths187 reports
- CoreValve™ Evolut™ PRO EVOLUTPRO-26-USAortic valve, prosthesis, percutaneously delivered10 deaths164 reports
- Evolut™ FX D-EVOLUTFX-34Aortic valve, prosthesis, percutaneously delivered16 deaths142 reports
- Evolut™ PRO+ EVPROPLUS-23USAortic valve, prosthesis, percutaneously delivered17 deaths134 reports
- CoreValve™ Evolut™ R EVOLUTR-26-USAortic valve, prosthesis, percutaneously delivered10 deaths107 reports
- Evolut™ FX EVOLUTFX-23Aortic valve, prosthesis, percutaneously delivered11 deaths106 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
- Evolut™ PRO+ D-EVPROP34USAortic valve, prosthesis, percutaneously delivered1 recall9 deaths54 reports
- Evolut™ FX+ EVFXPLUS-23Aortic valve, prosthesis, percutaneously delivered12 deaths88 reports
- CoreValve™ Evolut™ R EVOLUTR-29-USAortic valve, prosthesis, percutaneously delivered6 deaths72 reports
- CoreValve™ Evolut™ MCS-P3-31-AOA-USAortic valve, prosthesis, percutaneously delivered65 reports
- CoreValve™ Evolut™ PRO EVOLUTPRO-23-USAortic valve, prosthesis, percutaneously delivered4 deaths55 reports
- Evolut™ FX D-EVOLUTFX-34Aortic valve, prosthesis, percutaneously delivered38 reports
- CoreValve™ Evolut™ PRO EVOLUTPRO-23-USAortic valve, prosthesis, percutaneously delivered2 deaths25 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
- Evolut™ PRO+ L-EVPROP2329USAortic valve, prosthesis, percutaneously delivered2 reports
- Evolut™ FX L-EVOLUTFX-2329Aortic valve, prosthesis, percutaneously delivered2 reports
- CoreValve™ Evolut™ MCS-P3-29-AOA-USAortic valve, prosthesis, percutaneously delivered1 report
- Evolut™ PRO+ L-EVPROP34USAortic valve, prosthesis, percutaneously delivered1 report
- Evolut™ FX L-EVOLUTFX-2329Aortic valve, prosthesis, percutaneously delivered1 report
Recent Medtronic Evolut TAVR adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Packaging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952129 ↗MalfunctionSep 30, 2026Material Invagination
It was reported that prior to the attempted implant of a transcatheter aortic valve, a pre-implant balloon aortic valvuloplasty (BAV) was performed due to the patient's calcified anatomy. Upon the first deployment attempt, an infold was identified at a target implant depth of 3 millimeters (mm) on the non-coronary cusp (NCC) and 3 mm on the left coronary cusp (LCC). Subsequently, the valve was recaptured into the delivery catheter system (DCS), and the system was withdrawn from the patient. A new valve and DCS were then opened and used. A 6-minute procedural delay occurred as a result.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951581 ↗DeathSep 30, 2026Patient Device Interaction Problem; Unspecified Valve Regurgitation
Patient problems: Pulmonary Edema; Valvular Insufficiency/ Regurgitation
MAUDE report 50949854 ↗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 30, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50949195 ↗MalfunctionSep 30, 2026Activation Failure; Thickening of Material
It was reported that the day following the implant of this transcatheter bioprosthetic aortic valve within a pre-existing non-Medtronic transcatheter valve, a computed tomography (CT) was performed. The CT identified a fusiform thickening of the transcatheter aortic valve leaflets. This was consistent with Grade 2-3 hypoattenuated leaflet thickening (HALT). A transthoracic echocardiogram (TTE) was also performed. Baseline medication included anti-coagulation medication. Eliquis and aspirin would continue. The event was reported as resolving. No symptoms occurred due to HALT. The physician indicated the event was causal related to the transcatheter valve and the redo transcatheter valve implant procedure. Additional information indicated that prior to the implant of this transcatheter aortic bioprosthetic valve (TAV), a pre-implant dilatation of the non-Medtronic TAV was performed. During the valve-in-valve procedure, the second TAV was deployed and underexpansion of the Medtronic TAV occurred. A post-implant dilatation was performed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946641 ↗MalfunctionSep 29, 2026Patient Device Interaction Problem; Device Stenosis
Patient problems: Aortic Valve Stenosis; Heart Failure/Congestive Heart Failure
MAUDE report 50936820 ↗MalfunctionSep 29, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50936624 ↗InjurySep 29, 2026Patient Device Interaction Problem
It was reported that prior to the attempted implant of a transcatheter aortic valve, a pre-implant balloon aortic valvuloplasty (BAV) was performed with a non-Medtronic 23 millimeter (mm) balloon due to the patient's calcified and bicuspid native valve. Upon deployment of the first 3-4 nodes of the valve, it was identified that the valve was positioned too high relative to the target implant depth of 2 mm on the non-coronary cusp (NCC) and 3 mm on the left coronary cusp (LCC). Subsequently, the valve was recaptured into the delivery catheter system (DCS). Upon the second deployment attempt, an infold was identified. Subsequently, the valve was recaptured, and the system was withdrawn from the patient. An additional pre-implant BAV was performed with a non-Medtronic 25 mm balloon, and a new valve and DCS were opened and prepped. The second valve was implanted successfully, however the patient went into complete heart block (CHB) following the release of the valve. The following day, a permanent pacemaker was implanted for the CHB. Per the physician, the patient's bicuspid native valve and calcified anatomy contributed to the infold. A 10 minute procedural delay occurred as a result.
Patient problems: Heart Block
MAUDE report 50936256 ↗MalfunctionSep 29, 2026Material Invagination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936157 ↗InjurySep 29, 2026Unintended Collision
Patient problems: Foreign Body In Patient
MAUDE report 50935813 ↗MalfunctionSep 29, 2026Gradient Increase; Device Stenosis
Patient problems: Aortic Valve Stenosis; Insufficient Information; Transvalvular Pressure Gradient Increased
MAUDE report 50935308 ↗InjurySep 29, 2026Insufficient Device Problem Information; Unspecified Valve Regurgitation
Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information
MAUDE report 50934459 ↗InjurySep 28, 2026Intravalvular regurgitation
Patient problems: Aortic Valve Insufficiency/ Regurgitation
MAUDE report 50924020 ↗InjurySep 28, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50923972 ↗
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, combining the brand names used for this product line.
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page