CoreValve™ Evolut™ PRO EVOLUTPRO-29-US (UDI 00643169954458)Recalls & reported problems

Summary

The FDA's MAUDE database contains 276 adverse event reports that list this exact device (DI 00643169954458), received between Apr 27, 2017 and Sep 18, 2026 — classified as 17 deaths, 241 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Perivalvular Leak” (71 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 276 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Intravalvular regurgitation

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50829256 ↗
• InjuryJul 30, 2026Intravalvular regurgitation

  It was reported that approximately 7 years and 7 months following the implant of a transcatheter aortic valve, the valve failed due to severe central aortic regurgitation. The patient was scheduled for a valve-in-valve replacement for the same day as the onset of the regurgitation.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50086518 ↗
• InjuryJun 10, 2026Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 1 MONTH FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO STENOSIS. THE PATIENT IS SCHEDULED FOR A VALVE REPLACEMENT APPROXIMATELY 1 MONTH FOLLOWING THE ONSET OF THE VALVE STENOSIS.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 25460976 ↗
• InjuryMay 26, 2026Calcified

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 7 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE PATIENT WAS RE-HOSPITALIZED DUE TO VALVE CALCIFICATION. SUBSEQUENTLY, THE VALVE WAS EXPLANTED, AND A SURGICAL AORTIC VALVE WAS IMPLANTED.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 25283792 ↗
• InjuryApr 27, 2026Device Stenosis; Unspecified Valve Regurgitation

  IT WAS REPORTED THAT 8 YEARS AND 1 MONTH FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, SEVERE REGURGITATION AND AORTIC STENOSIS WERE IDENTIFIED. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED.

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

  MAUDE report 25006203 ↗
• InjuryApr 3, 2026Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 7 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO STENOSIS.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 24779476 ↗
• MalfunctionApr 1, 2026Thickening of Material

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 1 MONTH FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO GRADE I HYPOATTENUATED LEAFLET THICKENING (HALT). MILD TO MODERATE LEAFLET CALCIFICATION AND RESTRICTED MOBILITY OF THE LEAFLETS WERE ALSO OBSERVED. THE PATIENT IS BEING EVALUATED FOR POTENTIAL TREATMENT OPTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24754028 ↗
• InjuryMar 25, 2026Material Split, Cut or Torn; Intravalvular regurgitation

  IT WAS REPORTED THAT 8 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE (TAV), CENTRAL REGURGITATION AND A TORN LEAFLET WERE IDENTIFIED VIA COMPUTED TOMOGRAPHY ANGIOGRAM (CTA). SUBSEQUENTLY, REPLACEMENT FOR THE TRANSCATHETER AORTIC VALVE WAS PLANNED WITH THE USE OF ANOTHER TRANSCATHETER AORTIC VALVE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SEVERITY OF THE CENTRAL AORTIC REGURGITATION WAS SEVERE. THE PATIENT HAS NOT BEEN SCHEDULED FOR THE TAV-IN-TAV IN YET.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24689943 ↗
• InjuryMar 13, 2026Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation; Unspecified Valve Regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE FAILED DUE TO SEVERE AORTIC REGURGITATION, WHICH WAS IDENTIFIED IN RECENT ECHOCARDIOGRAM REPORTS. IT WAS PLANNED TO TREAT THE FAILED VALVE WITH A NON-MEDTRONIC TRANSCATHETER VALVE.

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

  MAUDE report 24594087 ↗
• MalfunctionFeb 18, 2026Perivalvular Leak; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 8 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO AN UNSPECIFIED CAUSE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE FAILED DUE TO MODERATE PARAVALVULAR LEAK (PVL). THERE WAS NO REPORTED INTERVENTION/TREATMENT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 24377388 ↗
• InjuryFeb 16, 2026Patient Device Interaction Problem; Thickening of Material; Unspecified Valve Regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 7 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE VALVE FAILED DUE TO AN UNKNOWN REASON. THREE MONTHS LATER, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED THAT REVEALED POSSIBLE THROMBUS/PANNUS FORMATION INSIDE OF THE VALVE FRAME. SUBSEQUENTLY, INTERVENTION WAS PLANNED BUT HAS NOT BEEN DETERMINED YET. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS TRANSCATHETER VALVE WAS IMPLANTED IN THE PATIENT'S NATIVE ANNULUS AT A FINAL IMPLANT DEPTH OF 4.2 MILLIMETERS (MM) ON THE LEFT CORONARY CUSP (LCC) AND 3.5 MM ON THE RIGHT CORONARY CUSP (RCC). THE MODE OF FAILURE OF THE VALVE WAS AORTIC INSUFFICIENCYOF UNKNOWN TYPE AND SEVERITY. HOWEVER, THERE WAS NO THROMBUS FORMATION. APPROXIMATELY 7 YEARS AND 8 MONTHS FOLLOWING THE IMPLANT OF THIS VALVE, A 23 MM NON-MEDTRONIC TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE WITH WIRE PROTECTION AT THE RIGHT CORONARY ARTERY.

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

  MAUDE report 24344407 ↗
• InjuryJan 8, 2026Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE SEVERITY OF THE CENTRAL AORTIC REGURGITATION WAS MODERATE TO SEVERE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24012541 ↗
• InjuryJan 5, 2026Calcified; Fluid/Blood Leak; Gradient Increase; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DISCHARGED HOME THE DAY AFTER THE VALVE-IN-VALVE PROCEDURE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information; Transvalvular Pressure Gradient Increased; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 23970808 ↗
• InjuryJan 5, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 1 DAY FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO ASYSTOLE.

  Patient problems: Asystole

  MAUDE report 23959559 ↗
• MalfunctionJan 2, 2026Gradient Increase; Patient Device Interaction Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 1 MONTH FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO MODERATE CENTRAL AORTIC REGURGITATION. THE PATIENT SUFFERED HEART FAILURE AND HEMODYNAMIC INSTABILITY AS RESULT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Heart Failure/Congestive Heart Failure; Hemodynamic instability; Transvalvular Pressure Gradient Increased

  MAUDE report 23944777 ↗
• InjuryDec 30, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT 7 YEARS AND 10 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, CENTRAL REGURGITATION OF SEVERE SEVERITY WAS IDENTIFIED. SUBSEQUENTLY, A 23 MM NON-MEDTRONIC WAS IMPLANTED VALVE-IN-VALVE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23921702 ↗
• InjuryDec 26, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 2 DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO COMPLETE HEART BLOCK (CHB).

  Patient problems: Heart Block

  MAUDE report 23897066 ↗
• InjuryDec 21, 2025Calcified; Gradient Increase; Device Stenosis; Calcified; Gradient Increase; Device Stenosis

  IT WAS REPORTED APPROXIMATELY EIGHT YEARS FOLLOWING THE IMPLANT OF THIS 29MM TRANSCATHETER AORTIC BIOPROSTHETIC VALVE (TAV), VALVE FAILURE WAS REPORTED. THE PRIMARY MODE OF VALVE FAILURE WAS STRUCTURAL VALVE DETERIORATION: PREDOMINANT AORTIC STENOSIS (AS) WITH SEVERE HEMODYNAMIC VALVE DETERIORATION. THIS WAS CHARACTERIZED BY AN INCREASE IN MEAN GRADIENT OF >=20MM HG FROM BASELINE AND A MEAN GRADIENT OF >=30MM HG. THE PATIENT WAS ENROLLED IN A CLINICAL STUDY WITH EXISTING, BASELINE VALVE FAILURE TO DETERMINE WHETHER A REDO-TAV REPLACEMENT PROCEDURE, TAV-IN-TAV, WAS APPROPRIATE. NO PATIENT SYMPTOMS PRIOR TO WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 23860468 ↗
• InjuryDec 17, 2025Perivalvular Leak; Intravalvular regurgitation; Perivalvular Leak; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE SEVERITY OF THE PARAVALVULAR LEAK (PVL) WAS MODERATE.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 23831243 ↗
• InjuryDec 12, 2025Perivalvular Leak; Patient Device Interaction Problem; Perivalvular Leak; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 1 MONTH FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE VALVE FAILED DUE TO SEVERE PARAVALVULAR LEAK (PVL) AND THE PATIENT WAS HOSPITALIZED. ADDITIONALLY, CONGESTIVE HEART FAILURE (CHF) OCCURRED AND WAS ATTRIBUTED TO THE VALVE. SUBSEQUENTLY, A SECOND TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE.

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

  MAUDE report 23793886 ↗
• InjuryDec 8, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 3 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, MODERATE CENTRAL AORTIC REGURGITATION WAS OBSERVED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23743291 ↗
• InjuryNov 20, 2025Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 11 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, MODERATE-SEVERE CENTRAL AORTIC REGURGITATION AND AORTIC STENOSIS WERE OBSERVED. SUBSEQUENTLY, A SECOND MEDTRONIC TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

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

  MAUDE report 23605352 ↗
• MalfunctionNov 18, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY EIGHT YEARS AND TWO MONTHS FOLLOWING THE IMPLANT OF THIS VALVE, IT WAS IDENTIFIED THAT THE VALVE FAILED. STRUCTURAL VALVE DETERIORATION WITH MODERATE HEMODYNAMIC VALVE DETERIORATION (HVD) SPECIFIED AS A NEW OCCURRENCE OR INCREASE OF >=1 GRADE OF INTRA-PROSTHETIC AORTIC REGURGITATION (AR) RESULTING IN >=MODERATE AR. NO INTERVENTION WAS REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23585724 ↗
• MalfunctionNov 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 1 MONTH FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, AN 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 23570619 ↗
• InjuryNov 12, 2025Patient Device Interaction Problem; Thickening of Material; Intravalvular regurgitation; Patient Device Interaction Problem; Thickening of Material; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY  7 YEARS AND 4 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE VALVE FAILED DUE TO SEVERE CENTRAL AORTIC REGURGITATION. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED THAT REVEALED POSSIBLE THROMBUS/PANNUS FORMATION INSIDE THE VALVE FRAME. SUBSEQUENTLY, THE PATIENT WAS EVALUATED FOR A POSSIBLE TRANSCATHETER AORTIC VALVE-IN-TRANSCATHETER AORTIC VALVE REPLACEMENT OR EXPLANT, AND WAS TRANSFERRED TO A DIFFERENT HOSPITAL.

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

  MAUDE report 23534966 ↗

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