CoreValve™ Evolut™ R EVOLUTR-23-US (UDI 00643169637986)Recalls & reported problems

Summary

The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 00643169637986), received between Mar 8, 2017 and Jan 28, 2026 — classified as 6 deaths, 82 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (26 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 104 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2026Material Split, Cut or Torn; Device Stenosis

  IT WAS REPORTED THAT 9 YEARS AND 9 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, VALVE STENOSIS WAS IDENTIFIED. SUBSEQUENTLY, THE VALVE WAS REPLACED WITH A TRANSCATHETER AORTIC VALVE THAT WAS IMPLANTED VALVE-IN-VALVE.

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

  MAUDE report 24199920 ↗
• MalfunctionJan 26, 2026Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 9 YEARS AND 11 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE VALVE FAILED DUE TO VALVULAR STENOSIS. THERE WAS NO REPORTED INTERVENTION OR TREATMENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Valvular Stenosis

  MAUDE report 24179359 ↗
• InjuryNov 24, 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 COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED THAT REVEALED THE VALVE FAILED FOR AN UNKNOWN REASON. SUBSEQUENTLY, THE PATIENT WAS EVALUATED FOR A TRANSCATHETER AORTIC VALVE-IN-TRANSCATHETER AORTIC VALVE REPLACEMENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE FAILURE WAS DUE TO STENOSIS AND NO TREATMENT HAS BEEN PLANNED. ADDITIONAL INFORMATION WAS RECEIVED THAT APPROXIMATELY EIGHT YEARS, ONE AND ONE HALF MONTHS FOLLOWING THE IMPLANT OF THE VALVE, SEVERE CENTRAL AORTIC REGURGITATION WAS OBSERVED. SUBSEQUENTLY, A SECOND TAV WAS IMPLANTED VALVE-IN-VALVE, AND THE SEVERITY OF THE REGURGITATION REDUCED TO TRACE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE WHEN THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR VALVE REPLACEMENT, THE INITIAL VALVE WAS EXPLANTED AND THE NEW TRANSCATHETER VALVE WAS IMPLANTED DURING AN OPEN SURGICAL PROCEDURE FOLLOWING THE EXPLANT.

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

  MAUDE report 23635599 ↗
• InjuryNov 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY FIVE MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO SICK SINUS SYNDROME (SSS). ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT APPROXIMATELY TWO MONTHS AFTER VALVE IMPLANT, THE PATIENT PRESENTED AT A DIFFERENT HOSPITAL IN ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE AND HAD A DIRECT CURRENT CARDIOVERSION DURING THE ADMISSION.

  Patient problems: Atrial Fibrillation; Non specific EKG/ECG Changes

  MAUDE report 23486624 ↗
• InjuryNov 5, 2025Fluid/Blood Leak; Perivalvular Leak; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation; Fluid/Blood Leak; Perivalvular Leak; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY SEVEN YEARS AND FIVE MONTHS FOLLOWING THE IMPLANT OF A 23 MILLIMETER (MM) TRANSCATHETER VALVE IN A PREVIOUSLY IMPLANTED 21 MM NON-MEDTRONIC (MITROFLOW) SURGICAL AORTIC VALVE, THE PATIENT WAS HOSPITALIZED WITH HEART FAILURE SYMPTOMS AND PNEUMONIA. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH ANTIBIOTICS AND BLOOD CULTURES WERE NEGATIVE. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED THAT REVEALED PULMONARY EDEMA, AND THE PATIENT WAS EVALUATED DUE TO SEVERE AORTIC INSUFFICIENCY. UPON CATHETERIZATION, SEVERE MID LEFT ANTERIOR DESCENDING (LAD) DISEASE WAS OBSERVED. THE PATIENT CONTINUED TO EXPERIENCE DYSPNEA, FATIGUE, AND ANGINA WITH NEW YORK HEART ASSOCIATION (NYHA) FUNCTIONAL CLASSIFICATION CLASS III SYMPTOMS. ADDITIONALLY, AORTIC VALVE STENOSIS WAS ALSO OBSERVED. SUBSEQUENTLY, A 20 MM NON-MEDTRONIC (EDWARDS SAPIEN) TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE VIA THE TRANSFEMORAL APPROACH. ADDITIONAL INFORMATION WAS RECEIVED INDICATING SEVERE CENTRAL AORTIC INSUFFICIENCY AND MODERATE PARAVALVULAR LEAK WERE DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY.

  Patient problems: Angina; Aortic Valve Insufficiency/ Regurgitation; Dyspnea; Fatigue; Heart Failure/Congestive Heart Failure; Pneumonia; Pulmonary Edema; Valvular Insufficiency/ Regurgitation; Valvular Stenosis

  MAUDE report 23479110 ↗
• MalfunctionOct 29, 2025Calcified; Device Stenosis; Calcified; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 11 MONTHS FOLLOWING THE IMPLANT OF A 23 MILLIMETER (MM) TRANSCATHETER VALVE IN A PREVIOUSLY IMPLANTED 21 MM NON-MEDTRONIC SURGICAL AORTIC VALVE, THE PATIENT VALVE FAILED DUE TO AORTIC STENOSIS (AS). A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED THAT REVEALED HEAVILY CALCIFIED LEAFLETS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Stenosis; Calcium Deposits/Calcification

  MAUDE report 23415161 ↗
• InjurySep 3, 2025Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED THAT APPROXIMATELY EIGHT YEARS, THREE AND A HALF MONTHS FOLLOWING VALVE IMPLANT, THE VALVE WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC SURGICAL AORTIC VALVE.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 22952539 ↗
• InjuryJul 31, 2025Gradient Increase; Perivalvular Leak; Device Stenosis; Intravalvular regurgitation; Gradient Increase; Perivalvular Leak; Device Stenosis; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPERIENCED FATIGUE DUE TO THE FAILED VALVE. THE PATIENT WAS DISCHARGED HOME THE DAY AFTER THE VALVE-IN-VALVE PROCEDURE.

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

  MAUDE report 22676556 ↗
• InjuryJul 25, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE VALVE FAILED DUE TO AN UNKNOWN REASON AND THE PATIENT PRESENTED WITH HEMODYNAMIC INSTABILITY. ADDITIONALLY, POTENTIAL THROMBUS WAS NOTED. SUBSEQUENTLY, AN UNKNOWN INTERVENTION WAS THEN PERFORMED.

  Patient problems: Hemodynamic instability; Thrombosis/Thrombus

  MAUDE report 22613370 ↗
• DeathJul 3, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 9 YEARS AND 5 MONTHS AFTER THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS UNSPECIFIED.

  Patient problems: Insufficient Information

  MAUDE report 22395094 ↗
• MalfunctionJun 24, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 3 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE VALVE FAILED DUE TO STENOSIS AND THE PATIENT PRESENTED WITH SYNCOPE.

  Patient problems: Aortic Valve Stenosis; Syncope/Fainting

  MAUDE report 22320936 ↗
• InjuryJun 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 10 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, A NON-MEDTRONIC (EDWARDS) T RANSCATHETER VALVE WAS IMPLANTED DUE TO AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 22318969 ↗
• InjuryJun 23, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, SEVERE CENTRAL AORTIC REGURGITATION OCCURRED.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 22311690 ↗
• InjuryJun 3, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 9 YEARS AND 4 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE VALVE FAILED DUE TO MILD-TO-MODERATE CENTRAL AORTIC REGURGITATION. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED AND A SECOND TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE (VIV).

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 22135414 ↗
• InjuryMay 23, 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 ONE DAY FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO COMPLETE HEART BLOCK (CHB).

  Patient problems: Heart Block

  MAUDE report 22080178 ↗
• InjuryMay 6, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF THIS EVOLUTR-23-US TRANSCATHETER AORTIC VALVE, VALVE STENOSIS WAS OBSERVED. A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT OF THE MEDTRONIC VALVE WAS PLANNED FOR APPROXIMATELY 5 DAYS LATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21969815 ↗
• InjuryMar 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER VALVE, AN UNKNOWN VALVE FAILURE OCCURRED. SUBSEQUENTLY, AN UNSPECIFIED INTERVENTION WAS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662498 ↗
• MalfunctionJan 10, 2025Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT SEVEN YEARS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE FAILED AND THE PATIENT HAD SHORTNESS OF BREATH (SOB) AND ELEVATED GRADIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea; Transvalvular Pressure Gradient Increased

  MAUDE report 21124196 ↗
• MalfunctionJan 8, 2025Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT FIVE YEARS AND FIFTEEN DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE IN A PATIENT WITH NEW YORK HEART ASSOCIATION CLASS II HEART FAILURE, AN ECHOCARDIOGRAM WAS PERFORMED. SUBSEQUENTLY, SEVEN DAYS LATER, THE PATIENT WAS EVALUATED FOR A FAILED VALVE DUE TO MILD-MODERATE AORTIC STENOSIS. FIVE YEARS AND ONE-MONTH POST-IMPLANT, A COMPUTED TOMOGRAPHY ANGIOGRAPHY AND FOLLOW UP OFFICE VISIT WERE PERFORMED. THE PATIENT REPORTED FEELING RELATIVELY WELL. NO TREATMENT WAS PERFORMED OR SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21105198 ↗
• InjuryJan 8, 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 PACEMAKER LEAD WAS IMPLANTED FOR AN UNSPECIFIED REASON.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 21104247 ↗
• MalfunctionJan 7, 2025Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT SEVEN YEARS AND FIVE MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT WAS EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT DUE TO AORTIC STENOSIS. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21092547 ↗
• MalfunctionJan 7, 2025Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS 1 MONTH FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE INTO A NON-MEDTRONIC SURGICAL VALVE, THE VALVE WAS IMAGED AND BIOPROSTHETIC VALVE DEGENERATION DUE TO AORTIC STENOSIS WAS REPORTED. NO TREATMENT WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21092255 ↗
• MalfunctionJan 7, 2025Gradient Increase; Device Stenosis; Gradient Increase; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 6 YEARS AND 4 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE WITHIN AN PRE-EXISTING SURGICAL VALVE, A HIGH GRADIENT WAS MEASURED AND STENOSIS OBSERVED. TREATMENT WAS NOT REPORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21091437 ↗
• MalfunctionJan 7, 2025Gradient Increase; Device Stenosis; Gradient Increase; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS 11 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE INTO A NON-MEDTRONIC SURGICAL VALVE, THE PATIENT WAS EVALUATED FOR REPLACEMENT DUE TO AORTIC STENOSIS AND HIGH GRADIENT. NO REPLACEMENT HAS BEEN PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21091401 ↗
• MalfunctionJan 2, 2025Degraded; Degraded

  IT WAS REPORTED THAT THERE WAS A VALVE PERFORMANCE ISSUE WITH THE EVOLUTR-23-US TRANSCATHETER AORTIC VALVE. THE MECHANISM OF FAILURE WAS NOT PROVIDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057281 ↗

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