CoreValve™ Evolut™ PRO EVOLUTPRO-26-US (UDI 00643169954441)Recalls & reported problems

Summary

The FDA's MAUDE database contains 164 adverse event reports that list this exact device (DI 00643169954441), received between Apr 26, 2017 and Jun 16, 2026 — classified as 10 deaths, 142 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (58 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 164 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026Gradient Increase; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 4 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO A MEAN GRADIENT OF 31 MILLIMETERS OF MERCURY (MMHG) AND MILD CENTRAL AORTIC REGURGITATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 25522669 ↗
• InjuryApr 21, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT 8 YEARS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A SURGICAL AORTIC VALVE FOR AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 24942744 ↗
• InjuryMar 3, 2026Calcified; Gradient Increase; Mechanics Altered; Activation Failure; Patient Device Interaction Problem; Thickening of Material

  IT WAS REPORTED THAT 8 YEARS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, HIGH VALVULAR GRADIENTS AND CALCIFICATION WERE IDENTIFIED.

  Patient problems: Calcium Deposits/Calcification; Transvalvular Pressure Gradient Increased

  MAUDE report 24501177 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

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

  Patient problems: Heart Block

  MAUDE report 24316197 ↗
• InjuryFeb 5, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 7 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE PATIENT WAS RE-HOSPITALIZED DUE TO AN UNSPECIFIED VALVE FAILURE. THE PATIENT IS BEING EVALUATED FOR A POTENTIAL VALVE-IN-VALVE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270214 ↗
• InjuryJan 20, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 5 DAYS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, ATRIO-VENTRICULAR (AV) BLOCK OF AN UNSPECIFIED DEGREE OCCURRED. SUBSEQUENTLY, A PERMANENT PACEMAKER WAS IMPLANTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 24119603 ↗
• InjuryDec 17, 2025Fluid/Blood Leak; Patient Device Interaction Problem; Thickening of Material; Fluid/Blood Leak; Patient Device Interaction Problem; Thickening of Material

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 9 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE VALVE FAILED DUE TO SEVERE AORTIC REGURGITATION WITH PROLAPSE OF THE ANTERIORLY-POSITIONED LEAFLET. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED THAT REVEALED POSSIBLE THROMBUS/PANNUS FORMATION INSIDE THE VALVE FRAME.

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

  MAUDE report 23831458 ↗
• MalfunctionDec 2, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 11 MONTHS 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694079 ↗
• InjuryNov 19, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO AORTIC STENOSIS OF THE VALVE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 23597679 ↗
• InjuryOct 29, 2025Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 8 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE VALVE FAILED DUE TO MODERATE CENTRAL AORTIC REGURGITATION. ADDITIONALLY, THE PATIENT EXPERIENCED SYMPTOMS OF HEMODYNAMIC INSTABILITY ATTRIBUTED TO THE VALVE AND WAS HOSPITALIZED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE WAS STENOTIC AND A 23 MM NON-MEDTRONIC (EDWARDS S3) TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE.

  Patient problems: Hemodynamic instability; Valvular Insufficiency/ Regurgitation; Valvular Stenosis

  MAUDE report 23414785 ↗
• MalfunctionAug 28, 2025Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 6 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE VALVE FAILED DUE TO A MODERATE PARAVALVULAR LEAK (PVL). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 22912616 ↗
• InjuryAug 13, 2025Fluid/Blood Leak; Gradient Increase; Perivalvular Leak; Insufficient Device Problem Information; Patient Device Interaction Problem; Thickening of Material; Intravalvular regurgitation; Fluid/Blood Leak; Gradient Increase; Perivalvular Leak; Insufficient Device Problem Information; Patient Device Interaction Problem; Thickening of Material; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT AT THE TIME OF THE VALVE IMPLANT WITHIN THE NATIVE AORTIC VALVE, THE TRANSCATHETER VALVE WAS PLACED AT 9 MILLIMETERS (MM) OF THE LEFT CORONARY CUSP (LCC) AND 7.2 MM ON THE NON-CORONARY CUSP (NCC). PRIOR TO THE IMPLANT DISCHARGE THE PEAK TRANSAORTIC VALVE GRADIENT MEASURED 18 MILLIMETERS OF MERCURY (MM HG). THE MEAN TRANSAORTIC GRADIENT MEASURED 9 MMHG. FOLLOWING THE VALVE IMPLANT THE PATIENT WAS PUT ON ASPIRIN AND AN ANTIPLATELET MEDICATION. AS REPORTED, ANTICOAGULATION THERAPY WAS NOT USED FOLLOWING THE VALVE IMPLANT. THE PATIENT WAS SEEN BY THE PHYSICIAN AND HAD REPORTED EXPERIENCING AN INCREASE IN EXERTIONAL DYSPNEA OVER THE PAST SEVERAL MONTHS. AT THE TIME THE THROMBUS WAS OBSERVED THE PEAK GRADIENT MEASURED 126.3 MMHG AND A MEAN GRADIENT OF 83 MMHG. THE REPORTED AORTIC INSUFFICIENCY WAS A COMBINATION OF BOTH MILD PARAVALVULAR LEAK (PVL) AND MILD-MODERATE CENTRAL REGURGITATION. TWENTY-THREE DAYS FOLLOWING THE PHYSICIAN APPOINTMENT, THE TRANSCATHETER VALVE WAS REVISED WITH A VALVE-IN-VALVE PROCEDURE TO ADDRESS THE AORTIC INSUFFICIENCY. AN ORAL ANTIPLATELET MEDICATION WAS STARTED WITH INTAKE EVERY TWELVE HOURS. PROLONGED HOSPITALIZAT

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

  MAUDE report 22796951 ↗
• InjuryAug 12, 2025Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 9 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE VALVE FAILED DUE TO STENOSIS. SUBSEQUENTLY, A SECOND NON-MEDTRONIC TRANSCATHETER VALVE WAS IMPLANTED, WITH MILD AORTIC INSUFFICIENCY NOTED FOLLOWING THE IMPLANT.

  Patient problems: Stenosis; Valvular Insufficiency/ Regurgitation

  MAUDE report 22784394 ↗
• InjuryAug 5, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 1 DAY FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED FOR COMPLETE HEART BLOCK (CHB).

  Patient problems: Heart Block

  MAUDE report 22718012 ↗
• MalfunctionJul 30, 2025Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 10 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE PATIENT PRESENTED WITH ELEVATED GRADIENTS. SUBSEQUENTLY, A REDO TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WAS PLANNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Transvalvular Pressure Gradient Increased

  MAUDE report 22668159 ↗
• InjuryJul 21, 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 2 DAYS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO AN UNSPECIFIED ATRIOVENTRICULAR (AV) BLOCK.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 22560447 ↗
• MalfunctionJun 24, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Thickening of Material; Insufficient Device Problem Information; Patient Device Interaction Problem; Thickening of Material

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 11 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE IN A HOMOGRAFT, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED THAT REVEALED THE VALVE HAD FAILED DUE TO AN UNKNOWN REASON. ADDITIONALLY, THROMBUS/PANNUS FORMATION ON THE VALVE LEAFLETS WAS OBSERVED. THE PATIENT WAS EVALUATED FOR A TRANSCATHETER AORTIC VALVE-IN-TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body Reaction; Thrombosis/Thrombus

  MAUDE report 22320710 ↗
• MalfunctionMay 27, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, VALVE STENOSIS WAS NOTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087530 ↗
• InjuryMay 20, 2025Gradient Increase; Insufficient Device Problem Information; Device Stenosis; Gradient Increase; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED THAT REVEALED THE VALVE HAD FAILED DUE TO AN UNKNOWN REASON. ADDITIONALLY, A MEAN GRADIENT OF 40 MILLIMETERS OF MERCURY (MM HG) WAS OBSERVED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Stenosis; Transvalvular Pressure Gradient Increased

  MAUDE report 22054095 ↗
• InjuryApr 22, 2025Degraded; Device Stenosis; Degraded; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 3 YEARS AND 5 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AN UNSPECIFIED VALVE FAILURE WAS NOTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Stenosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883820 ↗
• InjuryApr 22, 2025Calcified; Calcified

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS, 9 MONTHS, AND 19 DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, VALVE CALCIFICATION WAS OBSERVED. SUBSEQUENTLY, A SURGICAL AORTIC VALVE REPLACEMENT WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881446 ↗
• MalfunctionApr 21, 2025Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT SIX YEARS AND EIGHT MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, STENOSIS WAS REPORTED. THE PATIENT WAS BEING EVALUATED FOR TREATMENT OPTIONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875311 ↗
• MalfunctionMar 7, 2025Gradient Increase; Patient Device Interaction Problem; Device Stenosis; Gradient Increase; Patient Device Interaction Problem; Device Stenosis

  IT WAS REPORTED THAT SEVEN YEARS AFTER THE IMPLANT OF THE 26 MM EVOLUT PRO TRANSCATHETER AORTIC VALVE, THE PATIENT EXPERIENCED EXERTIONAL DYSPNEA AND FATIGUE. TWO MONTHS LATER, AN ECHOCARDIOGRAM REVEALED AORTIC STENOSIS, WITH A MEAN GRADIENT OF 35 MMHG, MODERATE MITRAL REGURGITATION, AND MODERATE TRICUSPID REGURGITATION. NO HOSPITALIZATIONS OCCURRED DUE TO THESE ISSUES. IT WAS ALSO REPORTED THAT THE EVOLUT PRO APPEARS TO BE IMPLANTED WITHIN A HOMOGRAFT OR STENTLESS XENOGRAFT SURGICAL AORTIC VALVE, AND A POSSIBLE PLAQUE /THROMBUS VERSUS INADEQUATE CONTRAST FILLING WAS SEEN NEAR THE VALVE. IT IS UNKNOWN IF ANY TREATMENT/INTERVENTION WAS PROVIDED OR IS PLANNED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE MEAN GRADIENT BEFORE THE VALVE WAS IMPLANTED WAS 27 MM. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PRIOR TO THE VALVE IMPLANT CONFIRMED SEVERE AORTIC STENOSIS. FOLLOWING THE VALVE IMPLANT, THE MEAN GRADIENT WAS 9 MMHG. ANTI-PLATELET THERAPY OF ACETYLSALICYLIC ACID (ASA) AND PLAVIX WAS PRESCRIBED. THE VALVE GRADIENT AT DISCHARGE WAS 5.4 MMHG. NO THROMBUS WAS PRESENT. THE TREATMENT PLAN IS ONGOING SURVEILLANCE WITH CLINICAL MONITORING.

  Patient problems: Aortic Valve Stenosis; Dyspnea; Fatigue; Mitral Valve Insufficiency/ Regurgitation; Thrombosis/Thrombus; Transvalvular Pressure Gradient Increased; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 21552521 ↗
• InjuryFeb 24, 2025Patient Device Interaction Problem; Intravalvular regurgitation; Patient Device Interaction Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS, 10 MONTHS, AND 2 WEEKS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, SEVERE CENTRAL AORTIC REGURGITATION WAS NOTED. THE LEFT CORONARY CUSP ALSO APPEARED ANEURYSMAL. APPROXIMATELY 5 DAYS LATER, A NON-MEDTRONIC VALVE WAS IMPLANTED IN THE PATIENT.

  Patient problems: Aneurysm; Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21447164 ↗
• InjuryFeb 21, 2025Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT A PATIENT WITH A MEDTRONIC TRANSCATHETER AORTIC VALVE REPLACEMENT EXPERIENCED MODERATE-SEVERE PARAVALVULAR LEAK (PVL). A NON-MEDTRONIC VALVE WAS IMPLANTED VALVE-IN-VALVE TO ADDRESS THE PVL.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 21432284 ↗

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-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-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-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