CoreValve™ Evolut™ R EVOLUTR-26-US (UDI 00643169637993)Recalls & reported problems

Summary

The FDA's MAUDE database contains 187 adverse event reports that list this exact device (DI 00643169637993), received between Dec 1, 2016 and Aug 6, 2026 — classified as 11 deaths, 163 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (39 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 187 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Device Stenosis

  It was reported that approximately 9 years and 4 months following the implant of a transcatheter aortic valve, the valve failed due to aortic stenosis.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 50160360 ↗
• InjuryJul 30, 2026Device Stenosis

  It was reported that 9 years and 11 months following implantation of a transcatheter aortic valve into a previously implanted surgical valve, aortic stenosis was identified and the patient was hospitalized.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 50082534 ↗
• MalfunctionJun 1, 2026Patient Device Interaction Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 11 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO CENTRAL AORTIC REGURGITATION OF UNSPECIFIED SEVERITY. THE PATIENT SUFFERED HEART FAILURE AND HEMODYNAMIC INSTABILITY AS A RESULT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 25348027 ↗
• InjuryMay 28, 2026Degraded; Activation Failure; Patient Device Interaction Problem; Thickening of Material

  IT WAS REPORTED, THIS TRANSCATHETER AORTIC VALVE (TAV) WAS IMPLANTED WITHIN A FAILED 25MM MEDTRONIC (MOSAIC) SURGICAL AORTIC VALVE. APPROXIMATELY EIGHT YEARS, EIGHT MONTHS FOLLOWING THE TAV IMPLANT, THE TAV FAILED DUE TO UNDER-EXPANSION AND THICKENED LEAFLETS WITH PANNUS AND THROMBUS FORMATION. ADDITIONAL INFORMATION WAS RECEIVED TO REPORT INTENT FOR THE PATIENT TO UNDERGO REINTERVENTION FOR THE DEGENERATED TAV.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25318921 ↗
• InjuryMar 26, 2026Device Stenosis

  IT WAS REPORTED THAT 7 YEARS AND 10 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, VALVE STENOSIS WAS IDENTIFIED. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 24708435 ↗
• MalfunctionFeb 24, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT 9 YEARS AND 7 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, CENTRAL REGURGITATION OF MODERATE SEVERITY WAS IDENTIFIED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24436837 ↗
• InjuryFeb 2, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 11 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO CENTRAL AORTIC REGURGITATION OF UNSPECIFIED SEVERITY. THE PATIENT IS CURRENTLY BEING EVALUATED FOR POTENTIAL TREATMENT OPTIONS.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24235361 ↗
• DeathJan 26, 2026Insufficient Device Problem Information; Patient Device Interaction Problem; Thickening of Material

  IT WAS REPORTED THAT 8 YEARS AND 9 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, AN UNSPECIFIED VALVE FAILURE OCCURRED.

  Patient problems: Foreign Body Reaction; Insufficient Information; Thrombosis/Thrombus

  MAUDE report 24183902 ↗
• InjuryJan 26, 2026Calcified; Gradient Increase; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT 7 YEARS AND 9 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE PATIENT HAD THE ONSET OF ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED. DURING THIS HOSPITALIZATION, AN ECHOCARDIOGRAM WAS OBTAINED WHICH REVEALED A REDUCED EJECTION FRACTION OF 30-35%, A MEAN VALVULAR GRADIENT OF 28 MILLIMETERS OF MERCURY (MM HG), MODERATE AORTIC STENOSIS, AND MILD CENTRAL REGURGITATION.

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

  MAUDE report 24177906 ↗
• InjuryJan 22, 2026Patient Device Interaction Problem

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

  Patient problems: Heart Block

  MAUDE report 24146459 ↗
• DeathJan 15, 2026Fluid/Blood Leak; Gradient Increase; Insufficient Device Problem Information; Patient Device Interaction Problem; Thickening of Material; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT 9 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, SEVERE AORTIC REGURGITATION WAS IDENTIFIED AS WELL AS A VALVULAR GRADIENT OF 34 MILLIMETERS OF MERCURY (MM HG). SUBSEQUENTLY, A TRANSCATHETER AORTIC VALVE PROCEDURE WAS PLANNED WITH A NON-MEDTRONIC VALVE. DUE TO THE HIGH VALVULAR GRADIENT AND REGURGITATION, THE PATIENT REQUIRED HOSPITALIZATION. PER THE PHYSICIAN, THE VALVE CONTRIBUTED TO THE PATIENT SYMPTOMS.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Asystole; Bradycardia; Heart Failure/Congestive Heart Failure; Non specific EKG/ECG Changes; Transvalvular Pressure Gradient Increased

  MAUDE report 24081130 ↗
• InjuryDec 18, 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 1 DAY FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED FOR COMPLETE HEART BLOCK (CHB).

  Patient problems: Heart Block

  MAUDE report 23840632 ↗
• InjuryDec 17, 2025Patient Device Interaction Problem; Thickening of Material; Device Stenosis; Intravalvular regurgitation; Patient Device Interaction Problem; Thickening of Material; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT 9 YEARS AND 6 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE INTO A PREVIOUSLY IMPLANTED SURGICAL AORTIC VALVE, CENTRAL REGURGITATION OF MODERATE SEVERITY WAS IDENTIFIED AS WELL AS AORTIC STENOSIS. SUBSEQUENTLY, THE PATIENT WAS EVALUATED FOR INTERVENTION VIA IMPLANTATION OF A TRANSCATHETER AORTIC VALVE INTO THE PREVIOUSLY IMPLANTED VALVE. ADDITIONAL INFORMATION WAS RECEIVED THAT PER THE PHYSICIAN, LEAFLET THICKENING AND THROMBUS/PANNUS FORMATION WERE OBSERVED ON THE VALVE LEAFLETS. SUBSEQUENTLY, A VALVE-IN-VALVE PROCEDURE WAS PLANNED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE FINAL IMPLANT DEPTH ON THE NON-CORONARY CUSP (NCC) WAS 10 MILLIMETER'S (MM), AND THE FINAL IMPLANT DEPTH ON THE LEFT CORONARY CUSP (LCC) WAS 10.2 MM. ADDITIONAL INFORMATION WAS RECEIVED TO CLARIFY THE FINAL IMPLANT DEPTH ON THE LCC WAS 5.7 MM. IT WAS CONFIRMED THAT THERE WAS NO THROMBUS NOTED, AND THE VALVE LEAFLETS APPEARED CALCIFIED. ADDITIONALLY, THE PATIENT EXPERIENCED DYSPNEA AND FATIGUE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE-IN-VALVE PROCEDURE HAS NOT BEEN SCHEDULED YET.

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

  MAUDE report 23834796 ↗
• InjuryDec 12, 2025Patient Device Interaction Problem; Intravalvular regurgitation; Patient Device Interaction Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 10 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE-IN-VALVE WITH AN INDWELLING SURGICAL AORTIC VALVE, THE VALVE FAILED DUE TO SEVERE CENTRAL AORTIC REGURGITATION. THE PATIENT SUFFERED FROM CONGESTIVE HEART FAILURE (CHF), AND WAS HOSPITALIZED AS A RESULT. THE PATIENT WAS SCHEDULED FOR A FURTHER VALVE-IN-VALVE PROCEDURE FOR THE FOLLOWING DAY.

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

  MAUDE report 23793595 ↗
• InjuryOct 22, 2025Fluid/Blood Leak; Gradient Increase; Device Stenosis; Fluid/Blood Leak; Gradient Increase; Device Stenosis

  IT WAS REPORTED THAT SEVEN YEARS AND SEVEN MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE (TAV) IN A PREVIOUSLY IMPLANTED NON-MEDTRONIC SURGICAL AORTIC VALVE (SAV), A VALVE PERFORMANCE ISSUE WAS IDENTIFIED. THE PATIENT WAS BEING WORKED UP FOR A POTENTIAL TAV-IN-TAV-IN-SAV. THE PRIMARY MODE OF VALVE FAILURE WAS STRUCTURAL VALVE DETERIORATION, THAT WAS FURTHER DESCRIBED AS MIXED AORTIC STENOSIS (AS) AND AORTIC REGURGITATION (AR), WITH SEVERE HEMODYNAMIC VALVE DETERIORATION (HVD), SPECIFIED AS AN INCREASE IN MEAN GRADIENT >= 20 MILLIMETERS OF MERCURY (MM HG) FROM BASELINE AND A MEAN GRADIENT OF >= 30MMHG. SEVEN DAYS LATER, A REDO TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WAS PERFORMED. THE IMPLANTED TAV WAS A NON-MEDTRONIC VALVE.

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

  MAUDE report 23361122 ↗
• InjuryOct 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON THE SAME DAY AS THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A NON-DEFIBRILLATOR LEAD WAS IMPLANTE D DUE TO AN UNSPECIFIED CONDUCTION DISTURBANCE.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23300091 ↗
• InjuryOct 15, 2025Patient Device Interaction Problem; Intravalvular regurgitation; Patient Device Interaction Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 10 YEARS FOLLOWING THE IMPLANT OF THE VALVE, THE VALVE FAILED DUE TO SEVERE CENTRAL AORTIC REGURGITATION, RESULTING IN HEMODYNAMIC INSTABILITY. APPROXIMATELY 2 WEEKS LATER, A NON-MEDTRONIC VALVE WAS IMPLANTED VALVE-IN-VALVE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Hemodynamic instability

  MAUDE report 23280188 ↗
• InjuryAug 11, 2025Fluid/Blood Leak; Intravalvular regurgitation; Fluid/Blood Leak; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 9 YEARS AND 9 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE VALVE FAILED DUE TO AORTIC INSUFFICIENCY AND THE NON-CORONARY CUSP (NCC) LEAFLET APPEARED FLAIL. SUBSEQUENTLY, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE AORTIC INSUFFICIENCY WAS MODERATE AND CENTRAL.

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

  MAUDE report 22777318 ↗
• InjuryAug 8, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 9 YEARS AND 10 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, SEVERE CENTRAL AORTIC REGURGITATION WAS OBSERVED. SUBSEQUENTLY, A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22750272 ↗
• InjuryJul 28, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 8 MONTHS FOLLOWING THE IMPLANT OF A 26 MILLIMETER (MM) TRANSCATHETER VALVE IN A PREVIOUSLY IMPLANTED 25 MM MEDTRONIC SURGICAL AORTIC VALVE, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED THAT REVEALED THE VALVE FAILED DUE TO AORTIC STENOSIS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 22632753 ↗
• MalfunctionJul 8, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 8 MONTHS AND 4 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED WHICH REVEALED THE VALVE HAD FAILED DUE TO AN UNKNOWN REASON AND THE PATIENT PRESENTED WITH CONGESTIVE HEART FAILURE (CHF). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22441034 ↗
• InjuryJun 24, 2025Fluid/Blood Leak; Insufficient Device Problem Information; Intravalvular regurgitation; Fluid/Blood Leak; Insufficient Device Problem Information; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE FAILED DUE TO AORTIC REGURGITATION. SUBSEQUENTLY, A NON-MEDTRONIC TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE.

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

  MAUDE report 22322483 ↗
• DeathJun 20, 2025Patient Device Interaction Problem; Thickening of Material; Intravalvular regurgitation; Patient Device Interaction Problem; Thickening of Material; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 6 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, AN ECHOCARDIOGRAM WAS PERFORMED THAT REVEALED THE VALVE WAS FUNCTIONING NORMALLY, AND NO REGURGITATION OR STENOSIS WAS OBSERVED. APPROXIMATELY 7 YEARS AND 9 MONTHS FOLLOWING THE IMPLANT THE VALVE, THE PATIENT PRESENTED TO THE HOSPITAL WITH DYSPNEA AND A LARGE PLEURAL EFFUSION FOR WHICH THORACENTESIS WAS PERFORMED. AN ECHOCARDIOGRAM WAS PERFORMED THE NEXT DAY THAT REVEALED MODERATE TO SEVERE AORTIC TRANSVALVULAR REGURGITATION WITH A PRESSURE HALF-TIME OF 149 MILLISECONDS (MS) AND DIASTOLIC FLOW REVERSAL, BUT NO EVIDENCE OF AORTIC VALVE STENOSIS. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED THAT REVEALED SEVERE AORTIC TRANSVALVULAR REGURGITATION. ADDITIONALLY, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED THAT REVEALED POSSIBLE LEFT ATRIAL APPENDAGE (LAA) THROMBUS AND SLIGHT LEAFLET THICKENING. THE PATIENT WAS HOSPITALIZED AND WAS BEING EVALUATED FOR A VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE.

  Patient problems: Aortic dissection; Dyspnea; Hemorrhage/Blood Loss/Bleeding; Pleural Effusion; Pulmonary Edema; Thrombosis/Thrombus; Valvular Insufficiency/ Regurgitation

  MAUDE report 22298431 ↗
• InjuryJun 18, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT APPROXIMATELY 9 YEARS AND 1 MONTH FOLLOWING THE IMPLANT OF THIS TRANSCATHETER VALVE, THE VALVE FAILED DUE TO POOR COAPTATION OF THE VALVE LEAFLETS AND THE PATIENT WAS HOSPITALIZED. SUBSEQUENTLY, A SECOND TRANSCATHETER VALVE WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22284355 ↗
• InjuryJun 17, 2025Patient Device Interaction Problem; Device Stenosis; Patient Device Interaction Problem; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE PATIENT PRESENTED WITH LOW CARDIAC OUTPUT. TWO DAYS LATER, THE VALVE FAILED DUE TO STENOSIS. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED AND A 2ND VALVE WAS IMPLANTED VALVE-IN-VALVE (VIV).

  Patient problems: Low Cardiac Output; Stenosis

  MAUDE report 22233870 ↗

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-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-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