CoreValve™ Evolut™ R EVOLUTR-29-US (UDI 00763000017675)Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 00763000017675), received between Apr 19, 2018 and Jun 11, 2026 — classified as 6 deaths, 61 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Perivalvular Leak” (21 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 72 reports, in the reporter's own words as published by the FDA.

• DeathJun 11, 2026Patient Device Interaction Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT 7 YEARS AND 7 MONTHS FOLLOWING IMPLANTATION OF A TRANSCATHETER AORTIC VALVE, THE PATIENT WAS HOSPITALIZED. DURING THIS HOSPITALIZATION IT WAS IDENTIFIED THAT SEVERE AORTIC VALVE CENTRAL REGURGITATION WAS PRESENT. ULTIMATELY, THE PATIENT DIED WHILE HOSPITALIZED. PER THE PHYSICIAN, BOTH THE PROCEDURE AND THE VALVE CONTRIBUTED TO THE PATIENT DEATH.

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

  MAUDE report 25474112 ↗
• InjuryApr 11, 2026Perivalvular Leak; Intravalvular regurgitation; Unspecified Valve Regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO PLAN TO TREAT THE PATIENT'S VALVE, AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 24852051 ↗
• InjuryApr 9, 2026Insufficient Device Problem Information; Patient Device Interaction Problem; Material Split, Cut or Torn; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 6 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO AN UNSPECIFIED CAUSE. SUBSEQUENTLY, A NON-MEDTRONIC VALVE WAS IMPLANTED VALVE-IN-VALVE.

  Patient problems: Aortic Valve Stenosis; Cusp Tear; Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 24834929 ↗
• InjuryApr 2, 2026Perivalvular Leak; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED THAT REVEALED SEVERE ECCENTRIC PROSTHETIC REGURGITATION AND TRACE CENTRAL AORTIC REGURGITATION.

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

  MAUDE report 24767968 ↗
• MalfunctionMar 2, 2026Calcified; Device Stenosis

  IT WAS REPORTED APPROXIMATELY 7 YEARS, FIVE-AND-A-HALF MONTHS AFTER THE IMPLANT OF A 29MM TRANSCATHETER AORTIC BIOPROSTHETIC VALVE, VALVE FAILURE WAS IDENTIFIED AND CHARACTERIZED AS STENOSIS WITH CALCIFICATION. NO TREATMENT OR INTERVENTION WAS PERFORMED. NO OTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489870 ↗
• InjuryDec 15, 2025Intravalvular regurgitation; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED INDICATED THE BASELINE TRANSTHORACIC ECHOCARDIOGRAM (TTE) MEASUREMENTS, PRIOR TO THE VALVE-IN-VALVE REVISION IDENTIFIED A MAX AORTIC VALVE VELOCITY (V2) OF 1.65 METERS PER SECOND (M/SEC), A MEAN AORTIC GRADIENT (MGV2) OF 5.94 MILLIMETERS OF MERCURY (MM HG), AN AORTIC VALVE AREA (AVA) OF 3.89 CENTIMETERS SQUARED (CM2), SEVERE TOTAL AORTIC PROSTHETIC REGURGITATION, SEVERE TRANSVALVULAR REGURGITATION, MODERATE MITRAL REGURGITATION (MR) AND MILD TRICUSPID REGURGITATION (TR).

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Foreign Body In Patient; Mitral Valve Insufficiency/ Regurgitation; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 23803089 ↗
• MalfunctionDec 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 5 YEARS AND 1 MONTH FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, UNSPECIFIED VALVE FAILURE WAS OBSERVED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727245 ↗
• InjuryNov 7, 2025Patient Device Interaction Problem; Thickening of Material; Intravalvular regurgitation; Patient Device Interaction Problem; Thickening of Material; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS PLACED ON BLOOD THINNERS AND INTERVENTION IS PLANNED.

  Patient problems: Foreign Body Reaction; Thrombosis/Thrombus; Valvular Insufficiency/ Regurgitation

  MAUDE report 23501141 ↗
• MalfunctionNov 4, 2025Patient Device Interaction Problem; Thickening of Material; Device Stenosis; Patient Device Interaction Problem; Thickening of Material; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 4 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE VALVE FAILED DUE TO STENOSIS. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED THAT REVEALED THROMBUS/PANNUS FORMATION ON THE VALVE LEAFLETS. SUBSEQUENTLY, THE PATIENT WAS EVALUATED FOR A TRANSCATHETER AORTIC VALVE-IN-TRANSCATHETER AORTIC VALVE REPLACEMENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED TO REPORT THE VALVE GRADIENT AT THE TIME THE THROMBUS WAS DETECTED WAS 12MM HG.

  Patient problems: Foreign Body Reaction; Thrombosis/Thrombus; Valvular Stenosis

  MAUDE report 23467320 ↗
• InjuryAug 20, 2025Gradient Increase; Perivalvular Leak; Insufficient Device Problem Information; Gradient Increase; Perivalvular Leak; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 9 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED WHICH REVEALED THE VALVE HAD FAILED DUE TO AN UNKNOWN REASON. SUBSEQUENTLY, A REDO-TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WAS DISCUSSED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE TRANSCATHETER VALVE WAS IMPLANTED INTO AN EXISTING SURGICAL VALVE. THE VALVE GRADIENT AT DISCHARGE WAS 15 MMHG WITH NO PARAVALVULAR LEAK (PVL). A FOLLOW-UP ECHOCARDIOGRAM ONE MONTH POST-IMPLANT SHOWED A 24 MMHG GRADIENT WITH TRACE PVL. THE EXACT FAILURE MODE WAS UNKNOWN BUT THERE WAS NOT A CURRENT PLAN FOR REINTERVENTION.

  Patient problems: Insufficient Information; Transvalvular Pressure Gradient Increased; Valvular Insufficiency/ Regurgitation

  MAUDE report 22852574 ↗
• InjuryAug 8, 2025Material Split, Cut or Torn; Intravalvular regurgitation; Material Split, Cut or Torn; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT 6 YEARS AND TWO MONTHS FOLLOWING THE VALVE IMPLANT, A NON-MEDTRONIC VALVE WAS IMPLANTED THE TREAT THE SEVERE CENTRAL AORTIC REGURGITATION VIA LEFT COMMON CAROTID.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Cusp Tear

  MAUDE report 22750771 ↗
• InjuryJul 18, 2025Perivalvular Leak; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Intravalvular regurgitation; Perivalvular Leak; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 4 YEARS AND 1 MONTH FOLLOWING THE IMPLANT OF THE BIOPROSTHETIC TRANSCATHETER AORTIC VALVE WITHIN A NON-MEDTRONIC SURGICAL AORTIC VALVE, A NON-STRUCTURAL VALVE DYSFUNCTION WAS REPORTED. A PARAVALVULAR LEAK WAS IDENTIFIED. THE SEVERITY OF THE PVL WAS NOT REPORTED. A ¿SEVERE¿ HEMODYNAMIC VALVE DETERIORATION WAS ALSO REPORTED. PATIENT SYMPTOMS WERE NOT REPORTED. THREE DAYS FOLLOWING NOTIFICATION OF THIS EVENT, A NON-MEDTRONIC TRANSCATHETER VALVE WAS IMPLANTED WITHIN THE MEDTRONIC TRANSCATHETER VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Valvular Insufficiency/ Regurgitation

  MAUDE report 22545326 ↗
• InjuryJun 30, 2025Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 5 YEARS AND 4 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE IN THE PATIENT'S NATIVE ANNULUS, THE VALVE FAILED DUE TO AN UNKNOWN REASON AND THE PATIENT PRESENTED WITH A MEAN GRADIENT OF 44 MILLIMETERS OF MERCURY (MMHG). IT WAS NOTED THAT THE IMPLANT DEPTH AT THE NON-CORONARY CUSP (NCC) WAS 7 MILLIMETERS (MM) AND THE IMPLANT DEPTH AT THE LEFT CORONARY CUSP (LCC ) WAS 8 MM. SUBSEQUENTLY, A 2ND TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE (VIV).

  Patient problems: Hemodynamic instability

  MAUDE report 22363533 ↗
• InjuryApr 30, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS, 4 MONTHS, AND 19 DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, POOR COAPTATION OF THE VALVE LEAFLETS WAS OBSERVED AND THE PATIENT WAS HOSPITALIZED. APPROXIMATELY 3 DAYS LATER, A VALVE-IN-VALVE PROCEDURE WAS PERFORMED TO ADDRESS THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 21937516 ↗
• InjuryMar 5, 2025Fluid/Blood Leak; Intravalvular regurgitation; Fluid/Blood Leak; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 3 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AORTIC INSUFFICIENCY WAS NOTED. PER THE PHYSICIAN, TREATMENT WILL BE REQUIRED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21528521 ↗
• MalfunctionNov 15, 2024Gradient Increase; Device Stenosis; Gradient Increase; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 5 YEARS AND 3 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A MEAN GRADIENT OF 40 MM HG AND AORTIC STENOSIS WAS NOTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Transvalvular Pressure Gradient Increased

  MAUDE report 20695726 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT FIVE DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO AN UNSPECIFIED ATRIO-VENTRICULAR BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 20438826 ↗
• InjuryOct 4, 2024Degraded; Activation Failure; Degraded; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 5 YEARS AND 5 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE WITHIN A SURGICAL AORTIC VALVE, AN UNSPECIFIED VALVE FAILURE OCCURRED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20375331 ↗
• InjuryAug 5, 2024Gradient Increase; Perivalvular Leak; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation; Gradient Increase; Perivalvular Leak; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 4 YEARS AND 1 MONTH FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AN INCREASED GRADIENT, AND POSSIBLE THROMBUS WERE REVEALED ON A COMPUTED TOMOGRAPHY SCAN. THE PATIENT WAS PROVIDED BLOOD THINNING MEDICATION. APPROXIMATELY 1 YEARS AND 6 MONTHS FOLLOWING THE LATER, AN ECHOCARDIOGRAM REVEALED AN AORTIC VALVE AREA OF 0.6 CM2, AORTIC VALVE MAXIMAL VELOCITY OF 5.0 M/S, A MEAN GRADIENT OF 16 MMHG, MODERATE AORTIC INSUFFICIENCY, AND MILD TO MODERATE PARAVALVULAR LEAK. DEVICE STENOSIS WAS ALSO NOTED. THE PATIENT'S BLOOD THINNING MEDICATION WAS CHANGED TO A NEW MEDICATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT A THROMBUS WAS NOT CONFIRMED. ADDITIONALLY, THE MEAN GRADIENT WAS NOTED TO BE 60 MMHG VIA ECHOCARDIOGRAPHY.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Thrombosis/Thrombus

  MAUDE report 19905759 ↗
• InjuryJul 24, 2024Calcified; Fluid/Blood Leak; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Calcified; Fluid/Blood Leak; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED STATING THAT THE VALVE REPLACEMENT WAS IMPLANTED DUE TO AN UNSPECIFIED INSUFFICIENCY AS WELL AS CALCIFICATION.

  Patient problems: Insufficient Information; Valvular Insufficiency/ Regurgitation

  MAUDE report 19819560 ↗
• InjuryJul 8, 2024Activation Failure; Device Stenosis; Activation Failure; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 4 YEARS AND 10 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE IN A PATIENT WITH A PREVIOUSLY IMPLANTED SURGICAL AORTIC VALVE AND CALCIFICATION IN THE PROXIMAL LEFT CORONARY ARTERY AND SINOTUBULAR JUNCTION, VALVE STENOSIS WAS NOTED. IT WAS ALSO NOTED THAT THE VALVE APPEARED UNDER-EXPANDED. PER THE PHYSICIAN, INTERVENTION WILL BE REQUIRED TO TREAT THE VALVE STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Stenosis

  MAUDE report 19689683 ↗
• InjuryJun 7, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO A SINUS NODE DYSFUNCTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 19491062 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED FOR SICK SINUS SYNDROME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 19489061 ↗
• InjuryMay 15, 2024Calcified; Device Stenosis; Calcified; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 5 YEARS AND 5 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, VALVE STENOSIS AND CALCIFICATION WERE NOTED. SHORTNESS OF BREATH WAS REPORTED. THE PATIENT IS ADMITTED AND A POSSIBLE VALVE-IN-VALVE WILL BE PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Valvular Stenosis

  MAUDE report 19321651 ↗
• InjuryApr 25, 2024Perivalvular Leak; Intravalvular regurgitation; Perivalvular Leak; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT FIVE YEARS AND FOUR MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE FAILED. THE FAILURE MODE WAS SEVERE PARAVALVULAR LEAK (PVL) WITH MILD-MODERATE MITRAL REGURGITATION (MR) ALSO PRESENT. PER THE PHYSICIAN, DUE TO CALCIFIC SHADOWING A MORE SIGNIFICANT STENOSIS CANNOT BE RULED OUT ON THE RIGHT SIDE. TREATMENT WAS PLANNED TO IMPLANT A REPLACEMENT VALVE-IN-VALVE (VIV). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 19179699 ↗

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-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-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-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