Evolut™ PRO+ EVPROPLUS-34USRecalls & reported problems

Summary

The FDA's MAUDE database contains 613 adverse event reports that list this exact device (DI 00763000211158), received between Oct 16, 2019 and Sep 29, 2026 — classified as 43 deaths, 498 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (136 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 613 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Gradient Increase; Device Stenosis

  Patient problems: Aortic Valve Stenosis; Insufficient Information; Transvalvular Pressure Gradient Increased

  MAUDE report 50935308 ↗
• 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 ↗
• InjuryJul 29, 2026Intravalvular regurgitation

  It was reported that approximately 6 years and 6 months following the implant of a transcatheter aortic valve, the valve failed due to severe central aortic regurgitation. Subsequently, a non-Medtronic (Edwards Sapien) valve was implanted valve-in-valve the following day.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50069733 ↗
• MalfunctionJun 8, 2026Perivalvular Leak

  IT WAS REPORTED THAT APPROXIMATELY 5 YEARS AND 11 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO PARAVALVULAR LEAK (PVL) OF UNSPECIFIED SEVERITY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 25429963 ↗
• InjuryJun 3, 2026Patient Device Interaction Problem; Thickening of Material; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 5 YEARS AND 6 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO SEVERE CENTRAL AORTIC REGURGITATION AND CALCIFIED LEAFLETS. MODERATELY DECREASED EJECTION FRACTION AND MILD PULMONARY REGURGITATION WERE ALSO OBSERVED VIA ECHOCARDIOGRAM.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Calcium Deposits/Calcification; Low Cardiac Output; Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 25381847 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 4 DAYS FOLLOWING IMPLANTATION OF A TRANSCATHETER AORTIC VALVE, ATRIO-VENTRICULAR (AV) BLOCK OF UNSPECIFIED DEGREE OCCURRED AND A PERMANENT PACEMAKER WAS IMPLANTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 25379864 ↗
• MalfunctionMay 29, 2026Insufficient Device Problem Information; Patient Device Interaction Problem; Thickening of Material

  IT WAS REPORTED THAT 4 YEARS AND 11 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, AN UNSPECIFIED VALVE FAILURE OCCURRED.

  Patient problems: Foreign Body Reaction; Insufficient Information; Thrombosis/Thrombus

  MAUDE report 25336900 ↗
• MalfunctionMay 26, 2026Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 5 YEARS AND 5 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO STENOSIS. THE PATIENT IS BEING EVALUATED FOR POTENTIAL TREATMENT OPTIONS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 25280794 ↗
• MalfunctionMay 21, 2026Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 3 YEARS AND 10 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO AORTIC STENOSIS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 25242626 ↗
• InjuryMay 14, 2026Patient Device Interaction Problem

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

  Patient problems: Heart Block

  MAUDE report 25177101 ↗
• DeathMay 11, 2026Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT 5 YEARS AND 10 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE PATIENT DIED DUE TO CARDIOGENIC SHOCK.

  Patient problems: Cardiogenic Shock

  MAUDE report 25144310 ↗
• InjuryMay 4, 2026Calcified; Gradient Increase; Perivalvular Leak; Patient Device Interaction Problem; Unspecified Valve Regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT HEAVY CALCIFICATION OF THE NATIVE AORTIC VALVE LEAFLETS AND CALCIFICATION OF THE TRANSCATHETER AORTIC BIOPROSTHETIC VALVE (TAV) LEAFLETS WHICH WAS IMPLANTED IN THE NATIVE VALVE WAS NOTED THAT MAY HAVE CONTRIBUTED TO THE ELEVATED GRADIENT. THE VALVE WAS NOTED TO BE SEATED DEEP APPROXIMATELY 11 MILLIMETER (MM) INTO THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) ACCORDING TO COMPUTED TOMOGRAPHY (CT). THERE WAS NO EVIDENCE OF HYPOATTENUATED LEAFLET THICKENING (HALT). THE SEVERE AORTIC REGURGITATION WAS NOTED TO BE PARAVALVULAR LEAK (PVL). THE EXACT LOCATION OF THE PVL WAS DIFFICULT TO IDENTIFY ON CT, BUT WAS POTENTIALLY FROM THE NON-CORONARY CUSP (NCC). CALCIFIED MEDIASTINAL LYMPH NODES WERE NOTED. FIBROTIC CHANGES IN THE VISUALIZED LUNGS ASSOCIATED WITH BRONCHIECTASIS WAS SEEN. SMALL BILATERAL PLEURAL EFFUSIONS WERE SEEN. TREATMENT WAS REPORTED TO BE PLANNED, BUT NOT YET KNOWN WHEN. IT WAS NOT KNOWN IF THE TAV OR THE IMPLANT PROCEDURE CONTRIBUTED TO THE EFFUSION. IT WAS NOTED ON THE CT REPORT THAT THE VALVE WAS IN POSITION, RELATIVELY LOW. HEAVY CALCIFICATION OF THE NATIVE AORTIC VALVE LEAFLETS WITH POSSIBLE PARAVALVULAR GAP AT THE NCC WAS SEEN WHIC

  Patient problems: Calcium Deposits/Calcification; Pericardial Effusion; Valvular Insufficiency/ Regurgitation

  MAUDE report 25070646 ↗
• MalfunctionApr 30, 2026Material Invagination

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE INFOLDED. PER THE PHYSICIAN, THE PATIENT'S ANATOMY CONTRIBUTED TO THE INFOLD. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO MISLOAD IDENTIFIED DURING LOADING. THE INFOLD OF THE VALVE FRAME WAS FIRST NOTICED DURING THE FIRST RECAPTURE. THE VALVE WAS RECAPTURED ONE TIME DUE TO THE IMPLANT DEPTH BEING TOO DEEP. SUBSEQUENTLY, THE VALVE WAS NOT IMPLANTED AND WAS WITHDRAWN FROM THE PATIENT. PER THE PHYSICIAN, THE PATIENT'S ANATOMY, SPECIFICALLY ANNULAR CALCIFICATION, CONTRIBUTED TO THE INFOLD. IT WAS NOTED THAT A PROCEDURAL DELAY OCCURRED AS A RESULT OF THE INFOLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25045776 ↗
• InjuryApr 27, 2026Patient Device Interaction Problem; Material Split, Cut or Torn; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE INITIAL IMPLANT PROCEDURE OF THE TRANCSATHETER VALVE, A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS NOT PERFORMED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Cusp Tear; Hemodynamic instability

  MAUDE report 25009715 ↗
• MalfunctionApr 21, 2026Material Invagination

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, THE DELIVERY CATHETER SYSTEM (DCS) WAS INSERTED INTO THE PATIENT'S BODY AND ADVANCED THROUGH THEIR ANATOMY. THE VALVE WAS THEN PARTIALLY DEPLOYED AND SUBSEQUENTLY RECAPTURED TWO TIMES. ON THE THIRD DEPLOYMENT ATTEMPT, AN INFOLD WAS NOTED. SUBSEQUENTLY, THE VALVE WAS RECAPTURED AND REMOVED FROM THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24942368 ↗
• InjuryApr 20, 2026Calcified; Device Stenosis

  IT WAS REPORTED THAT 5 YEARS AND 3 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, CALCIFICATION AND STENOSIS WERE IDENTIFIED. SUBSEQUENTLY, THE VALVE WAS REPLACED BY IMPLANTING A SECOND TRANSCATHETER VALVE INTO THE PREVIOUSLY IMPLANTED VALVE. PER THE PHYSICIAN, THE VALVE CONTRIBUTED TO THE CALCIFICATION AND STENOSIS.

  Patient problems: Aortic Valve Stenosis; Calcium Deposits/Calcification

  MAUDE report 24933017 ↗
• MalfunctionApr 15, 2026Device Stenosis

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

  Patient problems: Aortic Valve Stenosis

  MAUDE report 24888174 ↗
• MalfunctionApr 15, 2026Material Invagination

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, AN INFOLD WAS NOTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO MISLOAD IDENTIFIED DURING LOADING. THE INFOLD WAS FIRST NOTICED DURING THE FIRST DEPLOYMENT ATTEMPT, AND THE VALVE WAS NOT RECAPTURED. PER THE PHYSICIAN, THE PATIENT'S SEVERE CALCIFICATION CONTRIBUTED TO THE INFOLD. A PROCEDURAL DELAY DID NOT OCCUR AS A RESULT OF THE INFOLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887130 ↗
• InjuryApr 8, 2026Patient Device Interaction Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 4 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO SEVERE CENTRAL AORTIC REGURGITATION. THE PATIENT WAS RE-HOSPITALIZED AND SUFFERED CONGESTIVE HEART FAILURE (CHF) AND SHORTNESS OF BREATH (SOB) AS A RESULT.

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

  MAUDE report 24821355 ↗
• DeathApr 3, 2026Calcified; Perivalvular Leak; Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT NEITHER PNEUMONIA NOR THE SOURCE OF THE FEVERS WERE CONFIRMED. THE CARDIAC CATHETERIZATION THAT WAS PERFORMED WAS DIAGNOSTIC AND REVEALED THAT THE CORONARY ARTERIES WERE ALL ADEQUATELY PERFUSING. PER THE PHYSICIAN, THE TROPONIN ELEVATION MAY HAVE BEEN RELATED TO THE SEVERE AORTIC VALVE INSUFFICIENCY AND PULMONARY EDEMA. ADDITIONALLY PER THE PHYSICIAN, THE CAUSE OF DEATH WAS CONGESTIVE HEART FAILURE (CHF) DUE TO ACUTE SEVERE BIOPROSTHETIC AORTIC VALVE REGURGITATION. IT WAS NOTED THAT THE PATIENT HAD A MEDICAL HISTORY OF AN AORTIC VALVE REPLACEMENT AND CORONARY ARTERY BYPASS GRAFT, AND ACUTE ON CHRONIC SYSTOLIC AND DIASTOLIC CHF WITH AN EJECTION FRACTION OF 30%.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Calcium Deposits/Calcification; Cardiogenic Shock; Fever; Heart Failure/Congestive Heart Failure; Hemodynamic instability; Hemoptysis; Myocardial Infarction; Prolapse; Pulmonary Edema; Unspecified Infection

  MAUDE report 24778575 ↗
• InjuryMar 30, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 5 YEARS AND 8 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE (TAV), THE VALVE FAILED DUE TO CENTRAL AORTIC REGURGITATION OF UNSPECIFIED SEVERITY. PER THE PHYSICIAN, THE PATIENT'S BICUSPID NATIVE VALVE CONTRIBUTED TO THE REGURGITATION. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SEVERITY OF THE CENTRAL AORTIC REGURGITATION WAS MODERATE-SEVERE. THROMBUS/PANNUS FORMATION WAS NOT CONFIRMED. SUBSEQUENTLY, A TAV IN TAV PROCEDURE WITH A NON-MEDTRONIC TRANSCATHETER VALVE WAS PERFORMED AS TREATMENT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24729916 ↗
• InjuryMar 30, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF A 29 MILLIMETER (MM) TRANSCATHETER AORTIC VALVE, THE VALVE DISLODGED. SUBSEQUENTLY, THE VALVE WAS SNARED INTO THE SINOTUBULAR JUNCTION (STJ), AND A 34 MM VALVE WAS IMPLANTED VALVE-IN-VALVE. AN ADDITIONAL VALVE WAS IMPLANTED IN THE ASCENDING AORTIC ARCH IN ORDER TO SECURE THE 34 MM VALVE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24714683 ↗
• DeathMar 13, 2026Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation

  IT WAS REPORTED, APPROXIMATELY THREE YEARS, 11 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER AORTIC BIOPROSTHETIC VALVE, THE PATIENT PRESENTED TO AN OUTSIDE HOSPITAL. UPON ASSESSMENT, COMPLETE HEMODYNAMIC INSTABILITY WAS OBSERVED AND SEVERE CENTRAL REGURGITATION WAS IDENTIFIED. THE PATIENT WAS ADMITTED AND EXTRACORPOREAL MEMBRANE OXYGENATION WAS INITIATED. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Hemodynamic instability

  MAUDE report 24590833 ↗
• InjuryMar 13, 2026Patient Device Interaction Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 5 YEARS AND 11 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO SEVERE CENTRAL AORTIC REGURGITATION. THE PATIENT SUFFERED FROM HEMODYNAMIC INSTABILITY AS A RESULT. SUBSEQUENTLY, THE VALVE WAS EXPLANTED, AND A SURGICAL AORTIC VALVE WAS IMPLANTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Hemodynamic instability

  MAUDE report 24590820 ↗

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-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-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-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