CoreValve™ Evolut™ R EVOLUTR-29-US (UDI 00643169638006)Recalls & reported problems

Summary

The FDA's MAUDE database contains 300 adverse event reports that list this exact device (DI 00643169638006), received between Dec 1, 2016 and Sep 30, 2026 — classified as 22 deaths, 266 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Perivalvular Leak” (80 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 300 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Calcified; Gradient Increase; Device Stenosis

  It was reported that approximately 7 years and 7 months following the implant of a transcatheter aortic valve, the valve failed due to aortic stenosis, a mean gradient of 55 millimeters of mercury (mmHg) and calcification of the valve. The patient suffered from progressive dyspnea and fatigue as a result. The patient was screened for a possible valve-in-valve procedure.

  Patient problems: Aortic Valve Stenosis; Calcium Deposits/Calcification; Dyspnea; Fatigue; Transvalvular Pressure Gradient Increased

  MAUDE report 50949370 ↗
• MalfunctionSep 28, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918258 ↗
• InjuryJul 31, 2026Patient Device Interaction Problem

  It was reported that approximately 5 days following the implant of a transcatheter aortic valve, a permanent pacemaker was implanted for an atrio-ventricular (AV) block of unspecified severity.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 50105619 ↗
• DeathJul 20, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 8 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE PATIENT DIED DUE TO AN UNSPECIFIED CAUSE.

  Patient problems: Insufficient Information

  MAUDE report 25882248 ↗
• DeathMay 19, 2026Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 5 YEARS AND 1 MONTH FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO AORTIC STENOSIS. SUBSEQUENTLY, THE VALVE WAS EXPLANTED, AND A SURGICAL AORTIC VALVE WAS IMPLANTED ON THE SAME DAY THE STENOSIS WAS IDENTIFIED. APPROXIMATELY 20 DAYS LATER, THE PATIENT DIED DUE TO AN UNSPECIFIED CAUSE.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 25219698 ↗
• InjuryApr 10, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 5 YEARS AND 10 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: Insufficient Information

  MAUDE report 24839780 ↗
• InjuryMar 24, 2026Gradient Increase; Perivalvular Leak; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 9 YEARS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, MODERATE-SEVERE PARAVALVULAR LEAK (PVL), MODERATE-SEVERE CENTRAL AORTIC REGURGITATION, AORTIC STENOSIS, AND A MEAN GRADIENT OF 42 MILLIMETERS OF MERCURY (MM HG) WERE OBSERVED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT IS BEING EVALUATED TO DECIDE IF ANY FURTHER INTERVENTION IS NECESSARY.

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

  MAUDE report 24675512 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 13 DAYS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED FOR BRADYCARDIA/TACHYCARDIA SYNDROME.

  Patient problems: Bradycardia; Tachycardia

  MAUDE report 24640294 ↗
• InjuryMar 3, 2026Fluid/Blood Leak; Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 9 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 SEVERE AORTIC REGURGITATION. ADDITIONALLY, THROMBUS/PANNUS WAS NOT CONFIRMED. SIX DAYS AFTER THE FAILED VALVE WAS IDENTIFIED, A 23 MILLIMETER (MM) NON-MEDTRONIC TRANSCATHETER VALVE WAS IMPLANTED AS TREATMENT. FOLLOWING TREATMENT, THE PATIENT IS ALIVE AND DOING WELL. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SEVERE AORTIC REGURGITATION WAS CENTRAL REGURGITATION.

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

  MAUDE report 24497544 ↗
• MalfunctionFeb 16, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 9 YEARS AND 1 MONTH FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE VALVE FAILED DUE TO AN UNKNOWN REASON. THERE WAS NO INTERVENTION PROVIDED OR PLANNED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24344416 ↗
• InjuryFeb 6, 2026Device Stenosis

  IT WAS REPORTED, APPROXIMATELY 10 YEARS AFTER THE IMPLANT OF THIS 29 MILLIMETER (MM) TRANSCATHETER AORTIC BIOPROSTHETIC VALVE, IN A PATIENT WITH AORTIC STENOSIS (AS) AT BASELINE, THE VALVE FAILED DUE TO SEVERE AS WITH AN EJECTION FRACTION OF 45-50%. OF NOTE, THE PATIENT HAD A LEFT ATRIAL APPENDAGE WITH PLACEMENT OF AN EXISTING NON-MEDTRONIC CLOSURE DEVICE WITH POSSIBLE THROMBUS/PLAQUE OBSERVED. NO TREATMENT PLANS WERE REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT EIGHT DAYS LATER, A 26 MM NON-MEDTRONIC TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. F OLLOWING THIS PROCEDURE, THE PATIENT WAS HOSPITALIZED DUE TO VASCULAR COMPLICATIONS NOT REVELATED TO THE MEDTRONIC VALVE.

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

  MAUDE report 24283431 ↗
• InjuryJan 13, 2026Calcified; Gradient Increase; Malposition of Device; Device Stenosis

  IT WAS REPORTED THAT 8 YEARS AND 8 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, VALVE STENOSIS WAS IDENTIFIED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPERIENCED SHORTNESS OF BREATH AS A RESULT OF THE STENOSIS. LEAFLET CALCIFICATION WAS OBSERVED. IT WAS REPORTED THAT AN INTERVENTION WAS REQUIRED FOR THE STENOSIS, AND THE PATIENT WAS BEING EVALUATED FOR A VALVE-IN-VALVE PROCEDURE. IT WAS ALSO NOTED THAT THE VALVE WAS IMPLANTED DEEP AT 10MM ON THE NON-CORONARY CUSP AT THE INITIAL IMPLANT. ADDITIONAL INFORMATION WAS RECEIVED THAT AFTER ADMISSION, AN ECHOCARDIOGRAM SHOWED A MEAN GRADIENT OF 44 MMHG AND PEAK GRADIENT OF 80 MMHG. THE STENOSIS WAS NOTED TO BE SEVERE AND THE PATIENT EXPERIENCED CHEST PAIN AND DIZZINESS. THE PATIENT WAS ON PLAVIX BUT THE INDICATION AND START DATE WERE NOT KNOWN.

  Patient problems: Aortic Valve Stenosis; Calcium Deposits/Calcification; Chest Pain; Dizziness; Dyspnea

  MAUDE report 24054075 ↗
• MalfunctionJan 7, 2026Gradient Increase; Perivalvular Leak; Device Stenosis

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT BASELINE SYMPTOMS INCLUDED LOWER EXTREMITY SWELLING, FATIGUE, AND SHORTNESS OF BREATH. A VALVE-IN-VALVE PROCEDURE REVISION WAS PLANNED BUT NOT YET PERFORMED OR SCHEDULED.

  Patient problems: Dyspnea; Fatigue; No Clinical Signs, Symptoms or Conditions; Peripheral Edema

  MAUDE report 23992205 ↗
• MalfunctionDec 26, 2025Perivalvular Leak; Device Stenosis; Perivalvular Leak; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 9 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE VALVE FAILED DUE TO STENOSIS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Valvular Stenosis

  MAUDE report 23897668 ↗
• InjuryDec 17, 2025Intravalvular regurgitation; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE SEVERITY OF THE REGURGITATION PRIOR TO THE VALVE-IN-VALVE INTERVENTION WAS MODERATE-SEV ERE. FOLLOWING INTERVENTION, TRACE REGURGITATION REMAINED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23831401 ↗
• InjuryDec 11, 2025Fluid/Blood Leak; Perivalvular Leak; Fluid/Blood Leak; Perivalvular Leak

  IT WAS REPORTED THAT APPROXIMATELY 9 YEARS AND 5 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, SEVERE AORTIC INSUFFICIENCY WAS OBSERVED AND THE PATIENT WAS HOSPITALIZED WITH PLAN TO GO ON HOSPICE. THERE WAS NO FURTHER TREATMENT/INTERVENTION PERFORMED OR PLANNED.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 23782427 ↗
• InjuryDec 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT APPROXIMATELY 9 YEARS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO SEVERE AORTIC REGURGITATION.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 23729272 ↗
• InjuryDec 1, 2025Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 7 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO HIGH GRADIENT. THE PATIENT WAS EVALUATED FOR A POTENTIAL VALVE-IN-VALVE PROCEDURE.

  Patient problems: Transvalvular Pressure Gradient Increased

  MAUDE report 23685796 ↗
• InjuryNov 10, 2025Gradient Increase; Device Stenosis; Intravalvular regurgitation; Gradient Increase; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT 9 YEARS AND 25 DAYS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, MODERATE CENTRAL AORTIC REGURGITATION WAS OBSERVED. PATIENT WAS EVALUATED FOR A POSSIBLE VALVE-IN-VALVE OR EXPLANT PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea; Fatigue; Stenosis; Swelling/ Edema; Transvalvular Pressure Gradient Increased

  MAUDE report 23510186 ↗
• InjuryNov 4, 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 23467121 ↗
• InjuryOct 28, 2025Calcified; Gradient Increase; Patient Device Interaction Problem; Thickening of Material; Device Stenosis; Calcified; Gradient Increase; Patient Device Interaction Problem; Thickening of Material; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 9 YEARS AND 10 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE VALVE FAILED DUE TO STENOSIS. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED THAT REVEALED LEAFLET THICKENING AND CALCIFICATION WITH THROMBUS/PANNUS FORMATION. SUBSEQUENTLY, THE PATIENT WAS EVALUATED FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Calcium Deposits/Calcification; Foreign Body Reaction; Thrombosis/Thrombus; Transvalvular Pressure Gradient Increased; Valvular Stenosis

  MAUDE report 23404953 ↗
• InjuryOct 23, 2025Fluid/Blood Leak; Intravalvular regurgitation; Fluid/Blood Leak; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE FAILED DUE TO SEVERE CENTRAL AORTIC REGURGITATION.

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

  MAUDE report 23368715 ↗
• InjuryOct 23, 2025Fluid/Blood Leak; Patient Device Interaction Problem; Intravalvular regurgitation; Fluid/Blood Leak; Patient Device Interaction Problem; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE TYPE OF MODERATE AORTIC INSUFFICIENCY WAS CENTRAL. SUBSEQUENTLY, A 23 MILLIMETER (MM) N ON-MEDTRONIC TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE.

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

  MAUDE report 23368096 ↗
• InjuryOct 15, 2025Gradient Increase; Intravalvular regurgitation; Gradient Increase; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 9 YEARS AND 9 MONTHS FOLLOWING THE IMPLANT OF THE TRANSCATHETER BIOPROSTHETIC AORTIC VALVE A SEVERE HEMODYNAMIC VALVE DETERIORATION WAS IDENTIFIED SPECIFIC TO A STRUCTURAL VALVE DETERIORATION. THIS INVOLVED A NEW OCCURRENCE OR AN INCREASE OF =2 GRADES OF INTRA-PROSTHETIC AORTIC REGURGITATION RESULTING IN SEVERE AORTIC REGURGITATION. SEVEN DAYS LATER A VALVE-IN-VALVE REVISION OCCURRED VIA THE LEFT FEMORAL VEIN. A NON-MEDTRONIC VALVE WAS SUCCESSFULLY IMPLANTED. ADDITIONAL INFORMATION RECEIVED INDICATED PRIOR TO THE VALVE-IN-VALVE (VIV) REVISION THE PATIENT EXPERIENCED SWELLING IN THE LOWER E XTREMITIES, FATIGUE, AND SHORTNESS OF BREATH. HOSPITALIZATION WAS REQUIRED AS RESULT OF THE VIV. THE PATIENT WAS DISCHARGED 18 DAYS FOLLOWING ADMISSION.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea; Fatigue; Peripheral Edema

  MAUDE report 23301223 ↗
• InjuryOct 15, 2025Gradient Increase; Gradient Increase

  ADDITIONAL INFORMATION WAS RECEIVED THAT PRIOR TO THE VALVE IMPLANT, THE MEAN GRADIENT WAS 42 MILLIMETERS OR MERCURY (MMHG). THE VALVE GRADIENT AFTER THE VALVE WAS IMPLANTED WAS UNKNOWN BUT THE GRADIENT HAD INCREASED TO 42 MMHG. THE IMPLANT DEPTH WAS UNKNOWN BUT APPEARED DEEP. NO EVIDENCE OF THROMBUS OR LEAFLET THICKENING WAS OBSERVED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE).

  Patient problems: Transvalvular Pressure Gradient Increased

  MAUDE report 23279888 ↗

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 CE
• 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-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