CoreValve™ Evolut™ R EVOLUTR-34-US (UDI 00763000017682)Recalls & reported problems

Summary

The FDA's MAUDE database contains 442 adverse event reports that list this exact device (DI 00763000017682), received between Apr 30, 2018 and Sep 29, 2026 — classified as 24 deaths, 392 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Perivalvular Leak” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 442 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Insufficient Device Problem Information; Unspecified Valve Regurgitation

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 50934459 ↗
• InjurySep 17, 2026Patient Device Interaction Problem; Intravalvular regurgitation; Unspecified Valve Regurgitation

  It was reported that approximately 7 years and 3 months following the implant of a transcatheter aortic valve, the valve failed due to moderate to severe aortic insufficiency. The patient suffered from hemodynamic instability as a result. It was also noted that the patient is suffering from mitral regurgitation of unspecified severity. It was noted that the patient's stage IV kidney disease, the patient's calcified anatomy, and the initial depth of implant may be contributing factors to the aortic insufficiency. The patient is currently being evaluated for potential treatment options including a valve-in-valve procedure or an explant/surgical aortic valve implant.

  Patient problems: Hemodynamic instability; Mitral Valve Insufficiency/ Regurgitation; Valvular Insufficiency/ Regurgitation

  MAUDE report 50806402 ↗
• MalfunctionSep 4, 2026Perivalvular Leak; Insufficient Device Problem Information; Thickening of Material

  Additional information was received which indicated approximately 6 years and 11 months following the valve implant, at the 7-year follow-up clinic visit a transthoracic echocardiogram (TTE) showed suspect mild to moderate posterior paravalvular regurgitation. The physician indicated this was defined as not serious. A computed tomography angiogram (CTA) was ordered to further evaluate the valve. The CT identified grade-1 hypoattenuated leaflet thickening (HALT). Patient symptoms were not reported. Treatment was not required. The event was reported as resolving with a causal relationship to the transcatheter valve.

  Patient problems: Insufficient Information

  MAUDE report 50616098 ↗
• MalfunctionSep 4, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50611772 ↗
• InjuryAug 7, 2026Patient Device Interaction Problem; Unspecified Valve Regurgitation

  It was reported that approximately 8 years following the implant of a transcatheter aortic valve, the valve failed due to severe aortic insufficiency. The patient suffered hemodynamic instability and congestive heart failure (CHF) as a result. It was reported that the patient was planned for a valve-in-valve with a non-Medtronic valve on the evening of the onset of the valve failure.

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

  MAUDE report 50178188 ↗
• InjuryJul 30, 2026Perivalvular Leak; Patient Device Interaction Problem

  It was reported that approximately 6 years and 7 months following the implant of a transcatheter aortic valve, the valve failed due to severe paravalvular leak (PVL). As a result, the patient was hospitalized due to congestive heart failure (CHF), low grade cardiogenic shock, hypotension, global hypokinesis, and an ejection fraction of 25.3%. The patient was administered norepinephrine to treat the hypotension.

  Patient problems: Cardiogenic Shock; Heart Failure/Congestive Heart Failure; Low Blood Pressure/ Hypotension; Valvular Insufficiency/ Regurgitation

  MAUDE report 50082932 ↗
• InjuryMay 28, 2026Patient Device Interaction Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 10 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO CENTRAL AORTIC REGURGITATION OF UNSPECIFIED SEVERITY. THE PATIENT SUFFERED HEART FAILURE AND HEMODYNAMIC INSTABILITY AS A RESULT.

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

  MAUDE report 25323182 ↗
• InjuryMay 26, 2026Perivalvular Leak

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE PATIENT WAS RE-HOSPITALIZED DUE TO PARAVALVULAR LEAK (PVL) OF UNSPECIFIED SEVERITY. SUBSEQUENTLY, THE VALVE WAS EXPLANTED, AND A SURGICAL AORTIC VALVE WAS IMPLANTED.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 25285377 ↗
• MalfunctionMay 8, 2026Gradient Increase; Perivalvular Leak; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 9 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO A HIGH MEAN GRADIENT OF 31 MILLIMETERS OF MERCURY (MM HG) AND AORTIC STENOSIS, OBSERVED VIA TRANSTHORACIC ECHOCARDIOGRAM (TTE). TRACE PARAVALVULAR LEAK (PVL), MILD MITRAL AND MILD TRICUSPID REGURGITATION WERE ALSO OBSERVED. THE PATIENT NOTED SYMPTOMS OF DYSPNEA AND CHEST PRESSURE. THE PATIENT IS CURRENTLY BEING WORKED UP FOR A POTENTIAL VALVE-IN-VALVE PROCEDURE.

  Patient problems: Angina; Aortic Valve Stenosis; Dyspnea; Mitral Valve Insufficiency/ Regurgitation; Transvalvular Pressure Gradient Increased; Tricuspid Valve Insufficiency/ Regurgitation; Valvular Insufficiency/ Regurgitation

  MAUDE report 25128458 ↗
• InjuryMay 1, 2026Perivalvular Leak; Intravalvular regurgitation

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, MILD PARAVALVULAR LEAK (PVL) WAS NOTED. APPROXIMATELY 6 YEARS AND 7 MONTHS FOLLOWING THE INITIAL IMPLANT, THE VALVE FAILED DUE TO SEVERE CENTRAL AORTIC REGURGITATION.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 25059711 ↗
• InjuryApr 16, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 5 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE WAS EXPLANTED FOR AN UNSPECIFIED CAUSE. SUBSEQUENTLY, A SURGICAL AORTIC VALVE WAS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 24900299 ↗
• InjuryApr 1, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 8 MONTHS FOLLOWING THE IMPLANT OF THE TRANSCATHETER BIOPROSTHETIC AORTIC VALVE STRUCTURAL VALVE DETERIORATION SPECIFIC TO PREDOMINANT AORTIC REGURGITATION (AR). THIS WAS ASSOCIATED WITH ¿SEVERE¿ HEMODYNAMIC VALVE DETERIORATION SPECIFIC TO A NEW OCCURRENCE OR INCREASE OF >=2 GRADES OF INTRA-PROSTHETIC AR RESULTING IN GREATER THAN OR EQUAL TO SEVERE AR. PATIENT SYMPTOMS AND TREATMENT WERE NOT REPORTED. THE VALVE WAS BEING FURTHER EVALUATED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea; Fatigue; Peripheral Edema

  MAUDE report 24758711 ↗
• InjuryApr 1, 2026Gradient Increase; Perivalvular Leak; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED MILD PARAVALVULAR LEAK (PVL) AND A MEAN GRADIENT OF 22 MILLIMETERS OF MERCURY (MMHG). APPROXIMATELY 3 MONTHS LATER, A HEART CATHETERIZATION REVEALED THE MEAN GRADIENT WAS 23 MMHG. APPROXIMATELY 1 WEEK LATER, IT WAS OBSERVED THAT THE LEFT CORONARY CUSP (LCC) LEAFLETS HAD PROLAPSED, AND THERE WAS SEVERE CENTRAL AORTIC REGURGITATION AS WELL AS VALVE STENOSIS.

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

  MAUDE report 24755790 ↗
• InjuryMar 31, 2026Fluid/Blood Leak; Unspecified Valve Regurgitation

  IT WAS REPORTED, APPROXIMATELY SEVEN YEARS, TEN MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER AORTIC BIOPROSTHETIC VALVE (TAV), THE PRIMARY MODE OF TAV FAILURE WAS AORTIC REGURGITATION OF AN UNKNOWN SEVERITY AND TYPE. SUBSEQUENTLY, THE PATIENT WAS EVALUATED FOR POSSIBLE RE-INTERVENTION FOR THE FAILED TAV WITH A NON-MEDTRONIC (EDWARDS) TAV. UPON REVIEW OF TAV EVALUATION IMAGES, THE TAV FRAME APPEARED ELLIPTICAL/OVAL SHAPED. THERE WAS CALCIFICATION PRESENT IN THE SINOTUBULAR JUNCTION WHICH HAD A MEAN DIAMETER OF <(><<)>24MM. OF NOTE, IMAGES REVEALED A POSSIBLE NATIVE BICUSPID VALVE. NO PATIENT SYMPTOMS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24750319 ↗
• InjuryFeb 27, 2026Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT A SECOND NON-MEDTRONIC VALVE WAS IMPLANTED.

  Patient problems: Thromboembolism

  MAUDE report 24475368 ↗
• InjuryFeb 24, 2026Perivalvular Leak; Patient Device Interaction Problem; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS 34MM TRANSCATHETER BIOPROSTHETIC VALVE, ECHOCARDIOGRAPHY SHOWED TRACE PARAVALVULAR LEAK AND TRACE CENTRAL AORTIC REGURGITATION. NO TREATMENT WAS REPORTED. FORTY-THREE DAYS FOLLOWING VALVE IMPLANT, A 12-LEAD ELECTROCARDIOGRAM SHOWED NORMAL SINUS RHYTHM WITH FIRST DEGREE ATRIO-VENTRICULAR BLOCK. NO TREATMENT WAS PROVIDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT APPROXIMATELY 6 YEARS AND 3 MONTHS FOLLOWING THE IMPLANT OF THE TRANSCATHETER AORTIC VALVE AN ECHOCARDIOGRAM IDENTIFIED MILD AORTIC INSUFFICIENCY. APPROXIMATELY 1.5 MONTHS LATER THE PATIENT WAS SEEN AS AN OUTPATIENT AND AN ECHOCARDIOGRAM IDENTIFIED AN EJECTION FRACTION OF 65-70%. SMALL TO MODERATE PLEURAL EFFUSIONS AND AT LEAST MODERATE AORTIC INSUFFICIENCY WERE IDENTIFIED. MILD MITRAL REGURGITATION AND MILD TRICUSPID REGURGITATION WERE ALSO PRESENT. THE FOLLOWING DAY THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ACUTE HEART FAILURE WITH DECOMPENSATION IN THE SETTING OF SEVERE BIOPROSTHETIC AORTIC INSUFFICIENCY. AN ELEVATED TROPONIN LEVEL OCCURRED. MEDICATION WAS ADMINISTERED. TWO DAYS LATER AN ECHOCARDIOGRAM AND C

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Atrial Fibrillation; Cardiac Enzyme Elevation; Heart Block; Heart Failure/Congestive Heart Failure; Mitral Valve Insufficiency/ Regurgitation; Non specific EKG/ECG Changes; Pleural Effusion; Tricuspid Valve Insufficiency/ Regurgitation; Valvular Insufficiency/ Regurgitation

  MAUDE report 24438279 ↗
• MalfunctionFeb 20, 2026Fluid/Blood Leak; Patient Device Interaction Problem; Thickening of Material

  IT WAS REPORTED APPROXIMATELY 7 YEARS AND TWO-AND-A-HALF MONTHS FOLLOWING THE IMPLANT OF THIS 34MM TRANSCATHETER AORTIC BIOPROSTHETIC VALVE (TAV) UNSPECIFIED REGURGITATION WITH AN UNSPECIFIED SEVERITY WAS NOTED. DIAGNOSTIC IMAGING WAS PERFORMED WHICH SHOWED POSSIBLE PANNUS/THROMBUS VERSUS INADEQUATE CONTRAST FILLING SEEN INSIDE OF THE TAV FRAME. CALCIFICATION WAS OBSERVED IN THE SINOTUBULAR JUNCTION AND PROXIMAL LEFT CORONARY ARTERY. NO TREATMENT WAS REPORTED. NO OTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Calcium Deposits/Calcification; Thrombosis/Thrombus; Valvular Insufficiency/ Regurgitation

  MAUDE report 24406277 ↗
• InjuryFeb 17, 2026Calcified; Malposition of Device; Patient Device Interaction Problem; Thickening of Material

  IT WAS REPORTED, 6 YEARS, 6 AND A HALF MONTHS, AFTER THE IMPLANT OF A 34 MM TRANSCATHETER AORTIC BIOPROSTHETIC VALVE (TAV), THE VALVE FAILED. THE FAILURE WAS CHARACTERIZED BY THICKENED, CALCIFIED LEAFLETS WITH THE FRAME RANGING FROM 5.1-9.7-12 MM DEEP TO THE PATIENT'S NATIVE ANNULUS. CALCIUM BUILDUP WAS NOTED IN THE LEFT AND RIGHT CORONARY ARTERIES AND ANTEROMEDIALLY IN THE RIGHT FEMORAL ARTERY. THE PATIENT EXPERIENCED HEART FAILURE AND HEMODYNAMIC INSTABILITY. THE PATIENT WAS EVALUATED TO DETERMINE WHICH TREATMENT OPTION WAS APPROPRIATE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Calcium Deposits/Calcification; Heart Failure/Congestive Heart Failure; Hemodynamic instability

  MAUDE report 24369381 ↗
• InjuryFeb 17, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 5 DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO COMPLETE HEART BLOCK (CHB). ADDITIONAL INFORMATION WAS RECEIVED THAT THE CHB FIRST OCCURRED 3 DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER VALVE. IT WAS CLARIFIED THAT THE PACEMAKER WAS IMPLANTED 4 DAYS FOLLOWING THE IMPLANT OF THE VALVE.

  Patient problems: Heart Block

  MAUDE report 24365803 ↗
• InjuryFeb 17, 2026Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT COMPLETE HEART BLOCK (CHB) OCCURRED AFTER THE SECOND VALVE WAS IMPLANTED.

  Patient problems: Heart Block; Non specific EKG/ECG Changes; Valvular Insufficiency/ Regurgitation

  MAUDE report 24364731 ↗
• DeathFeb 13, 2026Patient Device Interaction Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, SEVERE CENTRAL AORTIC REGURGITATION WAS OBSERVED. THE PATIENT SUFFERED HEART FAILURE, AND WAS RE-HOSPITALIZED AS A RESULT. UNSPECIFIED INTERVENTION IS PLANNED TO ADDRESS THE SEVERE REGURGITATION. ADDITIONAL INFORMATION WAS RECEIVED THAT A VALVE-IN-VALVE PROCEDURE WAS PLANNED.

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

  MAUDE report 24337536 ↗
• InjuryFeb 13, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY (B)(6) FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, MODERATE CENTRAL AORTIC REGURGITATION WAS OBSERVED. ADDITIONALLY, THE PATIENT EXPERIENCED DYSPNEA AND FATIGUE, AND THE PHYSICIAN ATTRIBUTED THE SYMPTOMS TO THE TRANSCATHETER VALVE. SUBSEQUENTLY, THE PATIENT WAS REFERRED TO A SURGEON FOR SURGICAL INTERVENTION TO REPLACE THE TRANSCATHETER VALVE. ADDITIONAL INFORMATION WAS RECEIVED THAT TWO WEEKS AFTER THE AORTIC REGURGITATION WAS IDENTIFIED, THE PATIENT UNDERWENT A MINIMALLY INVASIVE AORTIC VALVE REPLACEMENT WITH A 23 MILLIMETER (MM) NON-MEDTRONIC SURGICAL VALVE WITH EXPLANT OF THE TRANSCATHETER VALVE, ASCENDING AORTIC AND AORTIC ROOT ENDARTERECTOMY, AND AORTIC ROOT REPAIR.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea; Fatigue

  MAUDE report 24334375 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 5 DAYS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED FOR LOW EJECTION FRACTION AND UNSPECIFIED ATRIAL ARRHYTHMIA.

  Patient problems: Arrhythmia

  MAUDE report 24303941 ↗
• InjuryFeb 3, 2026Fluid/Blood Leak; Intravalvular regurgitation

  IT WAS REPORTED THAT 7 YEARS AND 5 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, SEVERE AORTIC VALVE REGURGITATION WAS IDENTIFIED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24248600 ↗
• InjuryJan 29, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS FOLLOWING THE IMPLANT OF A 34 MILLIMETER (MM) TRANSCATHETER VALVE, THE VALVE FAILED DUE TO SEVERE CENTRAL AORTIC REGURGITATION. SUBSEQUENTLY, A 26 MM NON-MEDTRONIC (SAPIEN) TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE TWO DAYS LATER.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24209662 ↗

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-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 B
• 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 CE
• 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, Labeled as
• 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