CoreValve™ Evolut™ R EVOLUTR-34-US (UDI 00643169792340)Recalls & reported problems

Summary

The FDA's MAUDE database contains 436 adverse event reports that list this exact device (DI 00643169792340), received between Nov 30, 2016 and Aug 17, 2026 — classified as 21 deaths, 401 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Perivalvular Leak” (179 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 436 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2026Perivalvular Leak; Device Stenosis; Intravalvular regurgitation

  Additional information was received that the patient was admitted to the hospital two days prior to the valve-in-valve procedure and discharged four days later.

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

  MAUDE report 50278043 ↗
• DeathMay 27, 2026Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 5 YEARS AND 10 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE (TAV), THE PATIENT WAS RE-HOSPITALIZED DUE TO STENOSIS OF THE VALVE. A TAV-IN-TAV PROCEDURE WAS PERFORMED WITH A NON-MEDTRONIC (EDWARDS SAPIEN) VALVE; HOWEVER, THE PATIENT ULTIMATELY PASSED AWAY DUE TO COMPLICATIONS RELATED TO THE VALVE-IN-VALVE PROCEDURE. IT WAS NOTED THAT THE TRANSCATHETER VALVE WAS ULTIMATELY EXPLANTED. ADDITIONAL INFORMATION WAS RECEIVED TO CONFIRM THE MEDTRONIC TAV INDIRECTLY CONTRIBUTED TO THE PATIENT'S DEATH. IT WAS FURTHER NOTED IF THE MEDTRONIC TAV HAD NOT FAILED, THEN NO REDO-TAV REPLACEMENT WOULD NOT HAVE BEEN NECESSARY. ULTIMATELY, THE NON-MEDTRONIC (EDWARDS SAPIEN) TAV GOING INTO THE VENTRICLE, AND THE COMPLICATIONS FROM THAT, IS WHAT CAUSED THE PATIENT'S DEATH.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 25302340 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 4 DAYS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE AN UNSPECIFIED CONDUCTION DISTURBANCE.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 24945617 ↗
• MalfunctionApr 14, 2026Gradient Increase; Perivalvular Leak; Insufficient Device Problem Information; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE FAILED DUE TO STENOSIS, MILD PARAVALVULAR LEAK (PVL), AND A MEAN GRADIENT OF 36 M ILLIMETERS OF MERCURY (MM HG) ALONG WITH A PEAK VELOCITY OF 4.1 M/S. TREATMENT WAS NOT REPORTED.

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

  MAUDE report 24877751 ↗
• InjuryApr 1, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT 8 YEARS AND 6 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A SECOND NON-MEDTRONIC (EDWARDS) TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE FOR AN UNSPECIFIED REASON.

  Patient problems: Insufficient Information

  MAUDE report 24756002 ↗
• MalfunctionMar 30, 2026Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 9 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 24729905 ↗
• InjuryMar 30, 2026Patient Device Interaction Problem; Thickening of Material

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 7 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO AN UNSPECIFIED LEAFLET ISSUE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEAFLET ISSUE WAS HYPOATTENUATED LEAFLET THICKENING (HALT). THE PATIENT DID NOT EXPERIENCE ANY ADVERSE OUTCOMES AS A RESULT OF THE HALT. APPROXIMATELY 8 YEARS AND 5 MONTHS FOLLOWING THE IMPLANT OF THE VALVE, A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WAS PERFORMED WITH A NON-MEDTRONIC TRANSCATHETER VALVE AS INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716645 ↗
• InjuryMar 24, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 3 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO CENTRAL AORTIC REGURGITATION OF UNSPECIFIED SEVERITY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SEVERITY OF THE CENTRAL AORTIC REGURGITATION WAS SEVERE. SUBSEQUENTLY, A 26 MILLIMETER (MM) NON-MEDTRONIC TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE AS TREATMENT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24680312 ↗
• InjuryMar 18, 2026Calcified; Gradient Increase; Activation Failure; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 5 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO STENOSIS AND A GRADIENT OF APPROXIMATELY 50 MILLIMETERS OF MERCURY (MMHG). MILD CENTRAL AORTIC REGURGITATION WAS ALSO OBSERVED.

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

  MAUDE report 24626584 ↗
• InjuryFeb 9, 2026Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO AN UNSPECIFIED CAUSE. THE PATIENT IS BEING EVALUATED FOR A POTENTIAL VALVE-IN-VALVE PROCEDURE.

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

  MAUDE report 24293767 ↗
• InjuryJan 20, 2026Calcified; Gradient Increase; Thickening of Material; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT PER THE PHYSICIAN, THE PATIENT DID NOT HAVE ANY ANATOMICAL FEATURES THAT CONTRIBUTED TO THE ELEVATED GRADIENT. THE IMPLANT DEATH OF THE EVOLUT TRANSCATHETER VALVE TO THE NATIVE ANNULUS (LEFT CORONARY CUSP (LCC)) WAS 4.5 MILLIMETER (MM). THERE APPEARED TO BE SOME LEAFLET THICKENING ON THE RIGHT CORONARY CUSP (RCC) AND NON-CORONARY CUSP (NCC) LEAFLETS ON THE EVOLUT TRANSCATHETER VALVE AND SOME CALCIFICATION. THE EVOLUT TRANSCATHETER VALVE WAS REPLACED VALVE-IN-VALVE WITH A NON-MEDTRONIC VALVE.

  Patient problems: Transvalvular Pressure Gradient Increased; Valvular Stenosis

  MAUDE report 24116483 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 20 DAYS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO SICK SINUS SYNDROME (SSS).

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23984115 ↗
• InjuryJan 5, 2026Perivalvular Leak; Patient Device Interaction Problem; Thickening of Material; Intravalvular regurgitation

  IT WAS REPORTED APPROXIMATELY EIGHT YEARS, FOUR MONTHS FOLLOWING THE IMPLANT OF THIS 34MM TRANSCATHETER AORTIC BIOPROSTHETIC VALVE (TAV), VALVE FAILURE WAS REPORTED. THE PRIMARY MODE OF VALVE FAILURE WAS STRUCTURAL VALVE DETERIORATION: PREDOMINANT AORTIC REGURGITATION (AR) WITH SEVERE HEMODYNAMIC VALVE DETERIORATION. THIS WAS CHARACTERIZED BY A NEW OCCURRENCE OR INCREASE OF >=2 GRADES OF INTRA-PROSTHETIC AORTIC REGURGITATION RESULTING IN >=SEVERE CENTRAL AR. THE PATIENT WAS ADMITTED AND ENROLLED IN A CLINICAL STUDY WITH EXISTING, BASELINE VALVE FAILURE TO DETERMINE WHETHER A REDO-TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE, TAV-IN-TAV, WAS APPROPRIATE. PRE-INTERVENTION IMAGING WAS OBTAINED WHICH SHOWED POSSIBLE LEFT ATRIAL APPENDAGE THROMBUS VERSUS INADEQUATE CONTRAST FILLING. ADDITIONALLY, POSSIBLE PANNUS/THROMBUS AND LEAFLET THICKENING VERSUS INADEQUATE CONTRAST FILLING SEEN INSIDE OF THE TAV FRAME. PLAQUE/THROMBUS WAS NOTED IN THE RIGHT CIRCUMFLEX ILIAC ARTERY AND POSSIBLE PLAQUE/THROMBUS SEEN IN THE NATIVE SINUSES. FOUR DAYS AFTER THE VALVE FAILURE WAS IDENTIFIED, THE PATIENT WAS TREATED WITH RE-INTERVENTION FOR THE FAILED TAV. A NON-MEDTRONIC (EDWARDS SAPIEN) VALVE WAS IM

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

  MAUDE report 23967276 ↗
• MalfunctionJan 2, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 3 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, AN UNSPECIFIED VALVE FAILURE OCCURRED.

  Patient problems: Insufficient Information

  MAUDE report 23944210 ↗
• InjuryDec 30, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 5 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO MODERATE CENTRAL AORTIC REGURGITATION. THE PATIENT WAS SCHEDULED FOR A VALVE REPLACEMENT APPROXIMATELY 3 WEEKS FOLLOWING THE VALVE FAILURE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23922553 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 3 DAYS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED FOR COMPLETE HEART BLOCK (CHB).

  Patient problems: Heart Block

  MAUDE report 23909691 ↗
• InjuryDec 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON THE SAME DAY AS THE IMPLANT OF A TRANSCATHETER VALVE, A NON-DEFIBRILLATOR LEAD WAS PLACED IN THE RIGHT VENTRICULAR SEPTUM DUE TO AN UNSPECIFIED REASON.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23865564 ↗
• InjuryDec 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 9 YEARS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED FOR AN UNKNOWN REASON. SUBSEQUENTLY, A SURGICAL TISSUE VALVE WAS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 23839920 ↗
• InjuryDec 5, 2025Perivalvular Leak; Patient Device Interaction Problem; Thickening of Material; Intravalvular regurgitation; Perivalvular Leak; Patient Device Interaction Problem; Thickening of Material; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO MILD PARAVALVULAR LEAK (PVL) AND MODERATE CENTRAL AORTIC REGURGITATION. IT WAS REPORTED THAT THROMBUS FORMATION AND LEAFLET THICKENING WERE OBSERVED.

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

  MAUDE report 23732695 ↗
• InjuryDec 3, 2025Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED THAT REVEALED MODERATE TO SEVERE MITRAL REGURGITATION, AORTIC STENOSIS, AND CENTRAL AORTIC REGURGITATION OF UNSPECIFIED SEVERITY. APPROXIMATELY 1 MONTH LATER, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED THAT REVEALED THE VALVE FAILED DUE TO AN UNKNOWN REASON, AND THE PATIENT WAS HOSPITALIZED.

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

  MAUDE report 23708121 ↗
• InjuryNov 18, 2025Perivalvular Leak; Patient Device Interaction Problem; Intravalvular regurgitation; Perivalvular Leak; Patient Device Interaction Problem; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED INDICATED THE BASELINE TRANSTHORACIC ECHOCARDIOGRAM (TTE) NOTED A TRANSCATHETER AORTIC VALVE MEAN GRADIENT (MGV2) THAT MEASURED 4.03 MILLIMETERS OF MERCURY (MM HG). THE AORTIC VALVE AREA (AVA) MEASURED 3.12 CENTIMETERS SQUARED (CM2). THE MAX AORTIC VALVE VELOCITY (V2) MEASURE 1.51 METERS PER SECOND (M/SEC). SEVERE TOTAL AND TRANSVALVULAR AORTIC PROSTHETIC REGURGITATION AND MILD TRICUSPID REGURGITATION (TR) WAS IDENTIFIED.

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

  MAUDE report 23584072 ↗
• InjuryNov 16, 2025Fluid/Blood Leak; Intravalvular regurgitation; Fluid/Blood Leak; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY SEVEN YEARS AND THREE MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED THAT REVEALED THE VALVE FAILED DUE TO AORTIC INSUFFICIENCY OF UNSPECIFIED SEVERITY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE AORTIC INSUFFICIENCY WAS CENTRAL IN ORIGIN AND THE SEVERITY WAS MODERATE TO SEVERE. AT THE TIME THIS INFORMATION WAS RECEIVED, NO TREATMENT HAS BEEN PERFORMED TO ADDRESS THE INSUFFICIENT VALVE.

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

  MAUDE report 23565626 ↗
• InjuryNov 14, 2025Calcified; Patient Device Interaction Problem; Device Stenosis; Calcified; Patient Device Interaction Problem; Device Stenosis

  IT WAS REPORTED FROM THE PATIENT THAT APPROXIMATELY SEVEN YEARS AND ELEVEN MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE PATIENT EXPERIENCED SYMPTOMS OF DYSPNEA AND PLEURAL EFFUSION. ADDITIONALLY, THE PATIENT NOTED HAVING A PERMANENT PACEMAKER AN UNSPECIFIED AMOUNT OF TIME FOLLOWING THE IMPLANT OF THE TRANSCATHETER VALVE, EJECTION FRACTION OF 35%-40%, CONGESTIVE HEART FAILURE (CHF), KIDNEY PROBLEMS, AND WAS EVALUATED FOR THESE CONDITIONS. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT NO CONDUCTION DISTURBANCE WAS NOTED, BUT THE PATIENT HAD A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IMPLANTED APPROXIMATELY THREE YEARS AND NINE MONTHS AFTER THE TRANSCATHETER VALVE IMPLANT. IT WAS ALSO CONFIRMED THAT THE TRANSCATHETER VALVE DID NOT FAIL.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure; Non specific EKG/ECG Changes; Pleural Effusion; Unspecified Kidney or Urinary Problem

  MAUDE report 23556008 ↗
• InjuryNov 12, 2025Fluid/Blood Leak; Patient Device Interaction Problem; Intravalvular regurgitation; Fluid/Blood Leak; Patient Device Interaction Problem; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT SEVERE CENTRAL AORTIC REGURGITATION WAS CONFIRMED VIA ECHOCARDIOGRAM. MEDICAL TREATMENT WAS NOT PROVIDED.

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

  MAUDE report 23536212 ↗
• InjuryNov 12, 2025Fluid/Blood Leak; Insufficient Device Problem Information; Intravalvular regurgitation; Fluid/Blood Leak; Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 9 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE VALVE FAILED DUE TO AN UNKNOWN REASON. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 23535149 ↗

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