CoreValve™ Evolut™ R EVOLUTR-23-US (UDI 00763000017651)Recalls & reported problems

Summary

The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 00763000017651), received between Apr 30, 2018 and Jul 28, 2026 — classified as 15 deaths, 83 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (30 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 105 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Insufficient Device Problem Information

  It was reported that approximately 7 years and 7 months following the implant of a transcatheter aortic valve, the valve was explanted. Subsequently, a surgical aortic valve was implanted.

  Patient problems: Insufficient Information

  MAUDE report 50063751 ↗
• DeathMay 19, 2026Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 5 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO AORTIC STENOSIS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT SUBSEQUENTLY DIED. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 25220061 ↗
• MalfunctionMay 5, 2026Device Stenosis

  IT WAS REPORTED THAT 7 YEARS AND 3 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, VALVULAR STENOSIS WAS IDENTIFIED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 25082780 ↗
• InjuryMar 17, 2026Gradient Increase; Insufficient Device Problem Information; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT THAT IMMEDIATELY FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, INSIDE A PREVIOUSLY IMPLANTED NON-MEDTRONIC VALVE, THE PATIENT'S MEAN GRADIENT WAS 12 MILLIMETERS OF MERCURY (MM HG). (B)(6) FOLLOWING IMPLANT, THE PATIENT HAD A RECENT ECHOCARDIOGRAM THAT REVEALED A MAXIMUM GRADIENT OF 35 MILLIMETERS OF MERCURY (MM HG) AND A MEAN GRADIENT OF 19 MMHG. NO SYMPTOMS WERE REPORTED, AND NO TREATMENT WAS REPORTED OR PLANNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT APPROXIMATELY (B)(6) FOLLOWING THE IMPLANT OF THIS TRANSCATHETER AORTIC VALVE (TAV), A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED THAT REVEALED THE VALVE FAILED DUE TO AN UNKNOWN REASON. SUBSEQUENTLY, THE PATIENT WAS EVALUATED FOR A POSSIBLE TAV IN TAV. ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE FAILED DUE TO MODERATE-SEVERE CENTRAL AORTIC REGURGITATION, AND THERE IS NO TAV IN TAV PLANNED.

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

  MAUDE report 24619244 ↗
• MalfunctionFeb 17, 2026Patient Device Interaction Problem; Thickening of Material; Device Stenosis

  IT WAS REPORTED, APPROXIMATELY (B)(6), AFTER THE IMPLANT OF A 23 MM TRANSCATHETER AORTIC BIOPROSTHETIC VALVE (TAV), IN A PATIENT WITH A NATIVE BI-CUSPID VALVE, AORTIC STENOSIS WAS NOTED. REVIEW OF IMAGING SHOWED POSSIBLE PANNUS/THROMBUS VERSUS INADEQUATE CONTRAST FILLING SEEN INSIDE OF THE TAV FRAME. THE PATIENT WAS EVALUATED FOR A TAV-IN-TAV. NO TREATMENT WAS REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAS A HISTORY OF AORTIC STENOSIS (AS). FOR THE FIRST THREE MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER VALVE, THE PATIENT WAS ON DUAL ANTIPLATELET THERAPY (DAPT). THE THROMBUS/PANNUS WAS NOT CONFIRMED, AND THERE WAS NO AORTIC REGURGITATION. ADDITIONALLY, THE PATIENT WAS SYMPTOMATIC WITH DYSPNEA. NO TREATMENT WAS REPORTED.

  Patient problems: Dyspnea; No Clinical Signs, Symptoms or Conditions; Stenosis; Thrombosis/Thrombus

  MAUDE report 24369894 ↗
• InjuryJan 14, 2026Device Stenosis

  IT WAS REPORTED THAT 6 YEARS AND 7 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, VALVE STENOSIS WAS IDENTIFIED. SUBSEQUENTLY, THE VALVE WAS EXPLANTED AND REPLACED WITH A SURGICAL AORTIC VALVE.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 24067635 ↗
• MalfunctionDec 12, 2025Fluid/Blood Leak; Gradient Increase; Perivalvular Leak; Insufficient Device Problem Information; Patient Device Interaction Problem; Thickening of Material; Device Stenosis; Intravalvular regurgitation; Fluid/Blood Leak; Gradient Increase; Perivalvular Leak; Insufficient Device Problem Information; Patient Device Interaction Problem; Thickening of Material; Device Stenosis; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT 5 YEARS AND 3 MONTHS FOLLOWING THE IMPLANT OF THE VALVE, A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED THAT REVEALED MODERATE MITRAL REGURGITATION, AORTIC VALVE STENOSIS, AND MODERATE AORTIC REGURGITATION. 5 YEARS AND 5 MONTHS FOLLOWING THE IMPLANT OF THE VALVE, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED THAT REVEALED A MEAN AORTIC GRADIENT OF 15.1 MILLIMETERS OF MERCURY (MM HG), AND MILD PARAVALVULAR LEAK (PVL). THE PATIENT WAS BEING EVALUATED FOR TREATMENT OPTIONS AND A FOLLOW UP ECHOCARDIOGRAM WOULD BE PERFORMED IN 6 MONTHS.

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

  MAUDE report 23794198 ↗
• InjuryNov 19, 2025Patient Device Interaction Problem; Device Stenosis; Patient Device Interaction Problem; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT 6 YEARS AND 5 MONTHS FOLLOWING THE VALVE IMPLANT, THE TRANSCATHETER VALVE AND PREVIOUSLY IMPLANTED MEDTRONIC SURGICAL VALVE WERE EXPLANTED.

  Patient problems: Angina; Dyspnea; Low Cardiac Output; Valvular Stenosis

  MAUDE report 23596689 ↗
• InjuryJul 25, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 3 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC BIOPROSTHETIC VALVE, THE VALVE FAILED DUE TO SEVERE CENTRAL AORTIC REGURGITATION AND THE PATIENT WAS HOSPITALIZED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22611510 ↗
• InjuryJul 8, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 5 YEARS AFTER THE IMPLANT OF A TRANSCATHETER VALVE, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND THE VALVE FAILED DUE TO AN UNKNOWN REASON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT

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

  MAUDE report 22440991 ↗
• InjuryJun 6, 2025Fluid/Blood Leak; Insufficient Device Problem Information; Intravalvular regurgitation; Fluid/Blood Leak; Insufficient Device Problem Information; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22158240 ↗
• InjuryJun 3, 2025Gradient Increase; Patient Device Interaction Problem; Thickening of Material; Device Stenosis; Gradient Increase; Patient Device Interaction Problem; Thickening of Material; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 4 YEARS AND 9 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE VALVE FAILED DUE TO STENOSIS AND THE PATIENT PRESENTED WITH HIGH GRADIENTS. SUBSEQUENTLY, AN UNSPECIFIED INTERVENTION WAS PLANNED.

  Patient problems: Hemodynamic instability; Stenosis; Thrombosis/Thrombus

  MAUDE report 22132506 ↗
• InjuryMay 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 4 YEARS AND 8 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE WITHIN A TRANSCATHETER VALVE AND A FAILED SURGICAL AORTIC VALVE, THE PATIENT WAS HOSPITALIZED WITH HEART FAILURE AND HEMODYNAMIC INSTABILITY.

  Patient problems: Heart Failure/Congestive Heart Failure; Hemodynamic instability

  MAUDE report 22069990 ↗
• DeathApr 18, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY SIX YEARS AND ONE MONTH FOLLOWING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE INSIDE A PRE-EXISTING MEDTRONIC SURGICAL AORTIC VALVE, THE VALVE FAILED. THE MECHANISM OF FAILURE WAS NOT PROVIDED. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT DIED. THE CAUSE OF DEATH WAS UNKNOWN.

  Patient problems: Insufficient Information; Pneumonia

  MAUDE report 21865717 ↗
• InjuryMar 10, 2025Gradient Increase; Device Stenosis; Gradient Increase; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DEVELOPED SHORTNESS OF BREATH AS A RESULT OF THE STENOSIS AND A TRANSTHORACIC ECHOCARDIOGRAM (TTE) REVEALED HIGH GRADIENTS AND A TIGHT AORTIC VALVE AREA.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21559112 ↗
• MalfunctionJan 13, 2025Gradient Increase; Device Stenosis; Gradient Increase; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT FOUR YEARS AND TWO MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE FAILED. THE MECHANISM OF FAILURE WAS STENOSIS AND HIGH GRADIENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Stenosis; Transvalvular Pressure Gradient Increased

  MAUDE report 21144564 ↗
• InjuryOct 16, 2024Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE FAILED. THE FAILURE MODE OF THE VALVE WAS NOT REPORTED. NO TREATMENT WAS REPORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Valvular Stenosis

  MAUDE report 20464532 ↗
• InjuryAug 23, 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 DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED FOR ATRIO-VENTRICULAR (AV) BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 20052257 ↗
• MalfunctionJul 22, 2024Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION FROM A PATIENT THAT APPROXIMATELY FOUR YEARS AND SEVEN MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS DEVELOPING STENOSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Stenosis

  MAUDE report 19794929 ↗
• InjuryJul 10, 2024Gradient Increase; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation; Gradient Increase; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT A NON-MEDTRONIC VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Chest Pain; Heart Failure/Congestive Heart Failure; Mitral Valve Insufficiency/ Regurgitation; Stenosis

  MAUDE report 19710300 ↗
• InjuryMar 7, 2024Perivalvular Leak; Insufficient Device Problem Information; Intravalvular regurgitation; Perivalvular Leak; Insufficient Device Problem Information; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS 1 MONTH FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE FAILED. THE FAILURE MODE IS UNKNOWN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 18856525 ↗
• InjuryFeb 28, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 9 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT HAD CHEST PAIN AND RESPIRATORY DIFFICULTIES. X-RAY REVEALED WORSENING OF CONGESTION AND HIGH B-TYPE NATRIURETIC PEPTIDE (BNP) LEVELS. THE PATIENT WAS HOSPITALIZED AND MEDICATION WAS ADMINISTERED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Chest Pain

  MAUDE report 18796697 ↗
• DeathNov 15, 2023Gradient Increase; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation; Gradient Increase; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY FOUR YEARS AND NINE MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED FOR AN UNKNOWN REASON. SUBSEQUENTLY, A NEW MEDTRONIC SURGICAL TISSUE VALVE WAS IMPLANTED SUCCESSFULLY. NO FURTHER INFORMATION WAS PROVIDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Cardiac Arrest; Cardiovascular Dysfunction/Insufficiency; Dyspnea; Fatigue; Heart Failure/Congestive Heart Failure; Insufficient Information; Ischemia; Mitral Valve Insufficiency/ Regurgitation; Multiple Organ Dysfunction Syndrome

  MAUDE report 18139941 ↗
• MalfunctionOct 5, 2023Degraded; Degraded

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS 12 DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT DEVELOPED SHORTNESS OF BREATH, CHEST PAIN, AND FATIGUE. AN ECHOCARDIOGRAM AND COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) WERE PERFORMED THAT REVEALED A VALVE AREA OF .3 MILLIMETER'S (MM) ASSOCIATED WITH SEVERE AORTIC STENOSIS. NO TREATMENT WAS PROVIDED OR SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Chest Pain; Dyspnea; Fatigue

  MAUDE report 17882235 ↗
• InjurySep 27, 2023Degraded; Degraded

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS 11 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH AN ACUTE ONSET OF SHORTNESS OF BREATH AND CHEST DISCOMFORT AND FOUND TO HAVE CONGESTIVE HEART FAILURE. IT WAS NOTED THAT ECHOCARDIOGRAM DOCUMENTED CRITICAL BIOPROSTHETIC AORTIC STENOSIS WITH MILD LEFT VENTRICULAR DYSFUNCTION AND PEAK VELOCITY OF 5M/S. SIGNIFICANT LEFT VENTRICULAR HYPERTROPHY WAS OBSERVED AND CARDIAC CATHETERIZATION REVEALED NO CORONARY ARTERY DISEASE. SUBSEQUENTLY, NINE DAYS LATER, REDO STERNOTOMY, REDO AORTIC VALVE REPLACEMENT AND PATCH REPAIR OF THE AORTIC ROOT WERE PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Dyspnea; Heart Failure/Congestive Heart Failure; Myocardial Hypertrophy

  MAUDE report 17829215 ↗

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, Labeled as
• 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-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