Evolut FXRecalls & reported problems across all models

We found 14 models of Evolut FX by Medtronic Corevalve LLC in the FDA's device registry (GUDID). Together they are named in 3,745 adverse event reports in the FDA's MAUDE database, received between Jul 28, 2022 and Sep 30, 2026 — classified as 346 deaths, 2,158 injuries, 1,241 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1,428 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

Most reported Evolut FX problems

Evolut FX models

14 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Evolut™ FX EVOLUTFX-29

  Aortic valve, prosthesis, percutaneously delivered
  47 deaths564 reports
• Evolut™ FX EVOLUTFX-34

  Aortic valve, prosthesis, percutaneously delivered
  22 deaths563 reports
• Evolut™ FX D-EVOLUTFX-2329

  Aortic valve, prosthesis, percutaneously delivered
  79 deaths555 reports
• Evolut™ FX+ EVFXPLUS-29

  Aortic valve, prosthesis, percutaneously delivered
  30 deaths465 reports
• Evolut™ FX EVOLUTFX-26

  Aortic valve, prosthesis, percutaneously delivered
  51 deaths382 reports
• Evolut™ FX+ EVFXPLUS-34

  Aortic valve, prosthesis, percutaneously delivered
  7 deaths344 reports
• Evolut™ FX+ EVFXPLUS-26

  Aortic valve, prosthesis, percutaneously delivered
  46 deaths279 reports
• Evolut™ FX D-EVOLUTFX-2329

  Aortic valve, prosthesis, percutaneously delivered
  25 deaths216 reports
• Evolut™ FX D-EVOLUTFX-34

  Aortic valve, prosthesis, percutaneously delivered
  16 deaths142 reports
• Evolut™ FX EVOLUTFX-23

  Aortic valve, prosthesis, percutaneously delivered
  11 deaths106 reports
• Evolut™ FX+ EVFXPLUS-23

  Aortic valve, prosthesis, percutaneously delivered
  12 deaths88 reports
• Evolut™ FX D-EVOLUTFX-34

  Aortic valve, prosthesis, percutaneously delivered
  38 reports
• Evolut™ FX L-EVOLUTFX-2329

  Aortic valve, prosthesis, percutaneously delivered
  2 reports
• Evolut™ FX L-EVOLUTFX-2329

  Aortic valve, prosthesis, percutaneously delivered
  1 report

Recent Evolut FX 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 ↗
• 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 ↗
• 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 ↗
• InjurySep 28, 2026Intravalvular regurgitation

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50924020 ↗
• InjurySep 28, 2026Patient Device Interaction Problem

  It was reported that following the implant of a transcatheter aortic valve, the patient suffered a stroke. No further details were provided.

  Patient problems: Stroke/CVA

  MAUDE report 50915466 ↗
• InjurySep 25, 2026Device Dislodged or Dislocated

  It was reported that during implant of a transcatheter aortic bioprosthetic valve, the implant depth was 3mm at the non-coronary cusp and 5mm at the left coronary cusp. A post-implant balloon aortic valvuloplasty (BAV) was performed. During the BAV, valve dislodgement occurred. The valve dislodged to the sinus at the level of the sinotubular junction and was snared into the ascending aorta. A second Medtronic valve was implanted at the annulus level. The procedure was delayed by approximately one hour.

  Patient problems: Foreign Body In Patient

  MAUDE report 50897186 ↗
• MalfunctionSep 24, 2026Material Invagination; Appropriate Device Problem Term/Code Not Available

  It was reported that prior to the implant of a transcatheter aortic bioprosthetic valve, the valve was loaded into the delivery catheter system and upon fluoroscopic inspection of the valve load, frame overlap was observed extending to approximately the fourth node. During initial deployment to 80%, the infold did not resolve and extended to the top of the valve frame. The valve was recaptured and withdrawn from the patient. A replacement valve was loaded, screened, and successfully implanted. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50887528 ↗
• InjurySep 23, 2026Patient Device Interaction Problem

  It was reported that prior to the attempted implant of a transcatheter aortic valve in a patient with a recent history of 1st degree atrio-ventricular (AV) block, hospitalization due to paroxysmal atrial fibrillation with electrical cardioversion, and an active left bundle branch block (LBBB), a wide QRS complex was noted upon performance of a pre-implant balloon aortic valvuloplasty (BAV) and insertion of the guidewire. The valve was ultimately implanted successfully, and a bi-ventricular permanent pacemaker was implanted the following day.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 50871590 ↗
• InjurySep 22, 2026Insufficient Device Problem Information

  It was reported that approximately 3 years and 3 months following the implant of a transcatheter aortic valve, the valve was explanted for an unspecified reason. Subsequently, a surgical aortic valve was implanted.

  Patient problems: Insufficient Information

  MAUDE report 50856312 ↗
• DeathSep 22, 2026Insufficient Device Problem Information

  It was reported that following the implant of a transcatheter aortic valve into an indwelling surgical aortic valve, the patient died on the operating table due to an unspecified cause.

  Patient problems: Insufficient Information

  MAUDE report 50856075 ↗
• InjurySep 22, 2026Patient Device Interaction Problem

  It was reported that approximately three months following the implant of a transcatheter bioprosthetic valve, a permanent pacemaker was implanted due to complete heart block.

  Patient problems: Heart Block

  MAUDE report 50854356 ↗

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