Evolut™ PRO+ EVPROPLUS-29USRecalls & reported problems

Summary

The FDA's MAUDE database contains 869 adverse event reports that list this exact device (DI 00763000211127), received between Oct 23, 2019 and Sep 30, 2026 — classified as 57 deaths, 740 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (212 reports).

4 other recalls cover devices cleared under the same FDA submission (P130021); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 869 reports, 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 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 4, 2026Patient Device Interaction Problem; Intravalvular regurgitation

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Heart Failure/Congestive Heart Failure; Hemodynamic instability

  MAUDE report 50616614 ↗
• MalfunctionAug 24, 2026Intravalvular regurgitation

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50410351 ↗
• MalfunctionAug 7, 2026Gradient Increase; Patient Device Interaction Problem

  Patient problems: Thrombosis/Thrombus; Transvalvular Pressure Gradient Increased

  MAUDE report 50177972 ↗
• InjuryJul 30, 2026Gradient Increase; Perivalvular Leak; Patient Device Interaction Problem; Thickening of Material; Device Stenosis; Unspecified Valve Regurgitation

  It was reported that 4 years following implantation of a transcatheter aortic valve, a computed tomography angiogram (CTA) was obtained which indicated severe hypoattenuated leaflet thickening (HALT). The patient was then prescribed Warfarin and Eliquis, both of which they did not tolerate. Eventually, the patient was transitioned to Pradaxa. 5 years and 5 months following implantation of the valve, a transthoracic echocardiogram (TTE) was obtained which showed a ejection fraction of 55-60%. 5 years and 6 months following implantation of the valve, a second TTE was obtained that showed an ejection fraction of 35-40% and mild to moderate aortic valve regurgitation. The patient then presented to the emergency department 5 years and 7 months following implantation of the valve for dyspnea and generalized weakness. Subsequently, a third TTE was obtained, which reflected an ejection fraction of 28% and a high aortic valve mean gradient of 71 millimeters of mercury (mm Hg). Subsequently, the patient was admitted to the intensive care unit (ICU) and was intubated due to acute hypoxic and hypercapnic respiratory failure. Additionally, the patient was started on a Heparin drip due to suspec

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Dyspnea; Heart Failure/Congestive Heart Failure; Thrombosis/Thrombus; Transvalvular Pressure Gradient Increased

  MAUDE report 50083011 ↗
• InjuryJul 30, 2026Material Split, Cut or Torn

  It was reported that 6 years and 2 months following implantation of a transcatheter aortic valve, a tear in the leaflet of the valve was identified. Subsequently, the patient experienced shortness of breath and fatigue. In response, the transcatheter aortic valve was explanted and a non-Medtronic surgical aortic valve was implanted. Per the physician, the valve did cause or contribute to the patient symptoms.

  Patient problems: Cusp Tear; Dyspnea; Fatigue

  MAUDE report 50082834 ↗
• InjuryJul 28, 2026Intravalvular regurgitation

  It was reported that, approximately 6 years following the implant of a transcatheter aortic valve (TAV), severe central aortic regurgitation was observed. Treatment was subsequently planned. Additional information was received to report one day after the regurgitation was observed the patient underwent reintervention with a 23mm non-Medtronic (Edwards Sapien S3) valve implanted TAV-in-TAV. No patient complications were reported as a result of this event.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50060526 ↗
• InjuryJun 17, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC BIOPROSTHETIC VALVE IN A PATIENT WITH A BICUSPID AORTIC VALVE, THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION AND CARDIAC ARREST. THE NEXT DAY, AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS IMPLANTED.

  Patient problems: Cardiac Arrest; Ventricular Fibrillation

  MAUDE report 25536710 ↗
• InjuryJun 12, 2026Patient Device Interaction Problem; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 7 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE STENOSED AND THE PATIENT EXPERIENCED HEMODYNAMIC INSTABILITY AS A RESULT. SUBSEQUENTLY, A BALLOON AORTIC VALVULOPLASTY WAS PLANNED TO TREAT THE STENOSIS, HOWEVER UPON THE PERFORMANCE OF THE BAV, THE BALLOON GOT STUCK INSIDE OF THE VALVE FRAME. SUBSEQUENTLY THE VALVE WAS EXPLANTED.

  Patient problems: Aortic Valve Stenosis; Hemodynamic instability

  MAUDE report 25487074 ↗
• InjuryJun 8, 2026Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT 6 YEARS AND 6 MONTHS FOLLOWING IMPLANTATION OF A TRANSCATHETER AORTIC VALVE, MODERATE TO SEVERE CENTRAL REGURGITATION WAS IDENTIFIED AS WELL AS VALVE STENOSIS. IT WAS ADDITIONALLY NOTED THAT THE PATIENT WAS EXPERIENCING CONGESTIVE HEART FAILURE (CHF).

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Heart Failure/Congestive Heart Failure

  MAUDE report 25430451 ↗
• MalfunctionJun 1, 2026Calcified; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 1 MONTH FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO STENOSIS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 25348433 ↗
• MalfunctionMay 15, 2026Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO STENOSIS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 25188495 ↗
• InjuryMay 6, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 1 DAY FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED FOR COMPLETE HEART BLOCK (CHB).

  Patient problems: Heart Block

  MAUDE report 25094294 ↗
• DeathMay 4, 2026Perivalvular Leak; Patient Device Interaction Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 5 YEARS AND 7 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO SEVERE PARAVALVULAR LEAK (PVL) AND MODERATE CENTRAL AORTIC REGURGITATION. THE PATIENT WAS HOSPITALIZED AS A RESULT, AND ULTIMATELY DIED THE FOLLOWING DAY. PER THE PHYSICIAN, THE CAUSE OF DEATH WAS RESPIRATORY FAILURE SECONDARY TO THE AORTIC INSUFFICIENCY.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Valvular Insufficiency/ Regurgitation

  MAUDE report 25069222 ↗
• InjuryMay 1, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 1 DAY FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED FOR COMPLETE HEART BLOCK (CHB).

  Patient problems: Heart Block

  MAUDE report 25056226 ↗
• InjuryApr 22, 2026Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WILL BE PLACED ON ANTICOAGULATION MEDICATION FOR 30 DAYS, THEN HAVE A REPEAT ECHOCARDIOGRAM PERFORMED AND IF NEEDED IMPLANT A SECOND TRANSCATHETER VALVE.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 24956927 ↗
• InjuryApr 9, 2026Perivalvular Leak; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO AN UNSPECIFIED CAUSE.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure; Insufficient Information; Swelling/ Edema; Valvular Insufficiency/ Regurgitation

  MAUDE report 24831369 ↗
• MalfunctionApr 8, 2026Perivalvular Leak; Device Stenosis

  IT WAS REPORTED THAT 6 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, SEVERE STENOSIS WAS IDENTIFIED AS WELL AS MILD PVL VIA ECHOCARDIOGRAM.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Valvular Stenosis

  MAUDE report 24822833 ↗
• InjuryApr 8, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO AN UNSPECIFIED CAUSE. THE PATIENT SUFFERED CONGESTIVE HEART FAILURE (CHF) AND WAS RE-HOSPITALIZED AS A RESULT.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24821613 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 1 DAY FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO COMPLETE HEART BLOCK (CHB).

  Patient problems: Heart Block

  MAUDE report 24756275 ↗
• InjuryMar 30, 2026Gradient Increase; Insufficient Device Problem Information; Intravalvular regurgitation; Unspecified Valve Regurgitation

  IT WAS REPORTED THAT 5 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, AN UNSPECIFIED VALVE FAILURE OCCURRED AND THE PATIENT DEVELOPED SHORTNESS OF BREATH (SOB).

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea; Transvalvular Pressure Gradient Increased

  MAUDE report 24734755 ↗
• DeathMar 30, 2026Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT 4 YEARS AND 11 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, VALVE STENOSIS WAS IDENTIFIED. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DIED 3 DAYS LATER FOR AN UNKNOWN REASON.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 24731619 ↗
• InjuryMar 30, 2026Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO SEVERE AORTIC STENOSIS. A SECOND VALVE IMPLANT WITH A NON-MEDTRONIC VALVE WAS ATTEMPTED, HOWEVER IT WAS UNSUCCESSFUL. SUBSEQUENTLY, VALVE WAS ULTIMATELY EXPLANTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 24718782 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P130021. One submission often covers many models, so check the product and lot details in each record.

• Z-0561-2021 · Oct 23, 2020 · Terminated
  Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM JPN, VLV EVPROPLUS-23 COMM US; b. EVPROPLUS-26US, Labele
• Z-0559-2021 · Oct 23, 2020 · Terminated
  Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-23 TAV
• Z-0560-2021 · Oct 23, 2020 · Terminated
  Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-23, Labeled as: VLV EVOLUTPRO-23 PRO COMM 29L OUS, VLV EVOLUTPRO-23 BLUE 29L COMM OUS, VLV EVOLUTPRO-23
• Z-2264-2015 · Jul 15, 2015 · Terminated
  EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve delivery system for use with the Medtronic CoreValve Evol