CoreValve™ Evolut™ MCS-P3-26-AOA-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00643169448537), received between Mar 19, 2018 and May 15, 2026 — classified as 17 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Stenosis” (5 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Patient Device Interaction Problem; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 4 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO STENOSIS. THE PATIENT WAS HOSPITALIZED AND SUFFERED FROM HEART FAILURE AND HEMODYNAMIC INSTABILITY AS A RESULT. SUBSEQUENTLY, THE VALVE WAS EXPLANTED, AND A SURGICAL AORTIC VALVE WAS IMPLANTED.

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

  MAUDE report 25191616 ↗
• MalfunctionJul 25, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 10 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO AORTIC STENOSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 22611125 ↗
• InjuryMay 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE VALVE FAILED DUE TO AN UNKNOWN REASON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21970818 ↗
• InjurySep 3, 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 ONE DAY FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO AN UNSPECIFIED ATRIO-VENTRICULAR BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 20125775 ↗
• InjuryJul 25, 2024Gradient Increase; Insufficient Device Problem Information; Device Stenosis; Gradient Increase; Insufficient Device Problem Information; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS 3 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE FAILED. THE MECHANISM OF FAILURE WAS NOT PROVIDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Chest Pain; Dyspnea; No Clinical Signs, Symptoms or Conditions; Valvular Stenosis

  MAUDE report 19825233 ↗
• InjuryJun 4, 2024Device Stenosis; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE-IN-VALVE PROCEDURE HAD NOT BEEN SCHEDULE BECAUSE THE PATIENT WAS HIGH RISK. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED WITH FLASH PULMONARY EDEMA, PNEUMONIA, AND ACUTE ON CHRONIC RENAL FAILURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Pneumonia; Pulmonary Edema; Renal Failure

  MAUDE report 19461901 ↗
• MalfunctionMay 1, 2024Degraded; Patient Device Interaction Problem; Degraded; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT NO KNOWN INTERVENTION HAS BEEN PERFORMED FOR THIS VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea; Fatigue; Heart Failure/Congestive Heart Failure; Hypoxia

  MAUDE report 19221912 ↗
• InjuryJan 30, 2024Fluid/Blood Leak; Intravalvular regurgitation; Fluid/Blood Leak; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT SEVERE CENTRAL AORTIC INSUFFICIENCY WAS NOTED. A PLANNED INTERVENTION WAS REPORTED BUT THE TYPE OF INTERVENTION TO BE PERFORMED WAS UNKNOWN AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea; Valvular Insufficiency/ Regurgitation

  MAUDE report 18606274 ↗
• InjuryNov 15, 2023Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT EIGHT YEARS AND NINE MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT¿S FOLLOW-UP HOSPITAL VISIT REVEALED MODERATE-SEVERE AORTIC INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18138379 ↗
• InjuryOct 24, 2023Gradient Increase; Device Stenosis; Gradient Increase; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE MEAN GRADIENT (MG) BEFORE THE INITIAL VALVE IMPLANT WAS 57MMHG AND THE EJECTION FRACTION (EF) WAS 30%. DURING THE INITIAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR), THE FIRST VALVE DISLODGED, AND A SECOND VALVE WAS IMPLANTED IN THE NATIVE ANNULUS. CONCURRENTLY, PULMONIC VALVULOPLASTY WAS PERFORMED. ONE DAY POST-IMPLANT, THE MG ACROSS THE AORTIC VALVE WAS 21MMHG AND EF 45%. HOWEVER, LEFT VENTRICLE SYSTOLIC FUNCTION HAS ALSO IMPROVED CONSIDERABLY OVERNIGHT AND IT CONTRIBUTED TO THE INCREASED GRADIENT. ONE-MONTH POST-IMPLANT, THE MG WAS 12MMHG. THERE WAS NO EVIDENCE OF THROMBUS OR LEAFLET THICKENING ON THE BIOPROSTHETIC VALVE. IT WAS NOTED THAT THE PATIENT INITIALLY HAD A GOOD RESULT BUT NOW HAS HAD RECURRENT SYMPTOMS OF FATIGUE, DYSPNEA ON EXERTION AND PAROXYSMAL NOCTURNAL DYSPNEA. THE PATIENT REPORTED EPISODES OF CHEST PAIN. NO DIZZINESS OR SYNCOPE WAS NOTED. THE PATIENT¿S WORK-UP SHOWED SEVERE BIOPROSTHETIC AORTIC STENOSIS WITH A VALVE AREA OF 0.62CM2. THE PATIENT WAS SCHEDULED FOR REPEAT TAVR IN APPROXIMATELY ONE MONTH. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Chest Pain; Dyspnea; Fatigue; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17994907 ↗
• InjuryMay 19, 2023Degraded; Degraded

  MEDTRONIC RECEIVED INFORMATION THAT EIGHT YEARS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT WAS EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT DUE TO MODERATE AORTIC INSUFFICIENCY AND AORTIC STENOSIS. A 23 MM NON-MEDTRONIC (SAPIEN) TRANSCATHETER VALVE WAS IMPLANTED AT THE FOURTH NODE OF THE FAILED MEDTRONIC VALVE. THE REPLACEMENT WAS SUCCESSFUL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 16962901 ↗
• InjuryJun 2, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY SIX YEARS AND TEN MONTHS AFTER THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS REPLACED WITH A NON-MEDTRONIC VALVE FOR AN UNKNOWN REASON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14576354 ↗
• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 6 YEARS, 8 MONTHS, AND 15 DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, SEVERE AORTIC INSUFFICIENCY WAS NOTED. A NON-MEDTRONIC VALVE WAS IMPLANTED VIA A TRANSFEMORAL APPROACH. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 12812930 ↗
• InjuryNov 9, 2021Gradient Increase; Patient Device Interaction Problem; Gradient Increase; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT SIX YEARS AND FIVE MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, HIGH GRADIENT AND STENOSIS WITH CALCIFIED LEAFLETS WERE REPORTED. A NON-MEDTRONIC VALVE WAS IMPLANTED VALVE IN VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 12783594 ↗
• InjuryOct 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT FOUR DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, COMPLETE HEART BLOCK WAS OBSERVED AND A PERMANENT PACEMAKER WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 12647798 ↗
• InjuryApr 29, 2020Gradient Increase; Material Puncture/Hole; Gradient Increase; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY FOUR YEARS AND TEN MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THERE WAS A HIGH GRADIENT ACROSS THE VALVE, AND A HOLE IN ONE OF THE LEAFLETS THAT WAS HEAVILY CALCIFIED. THE VALVE WAS SURGICALLY REMOVED AND REPLACED WITH A NON-MEDTRONIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 10012107 ↗
• InjuryDec 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT ONE DAY AFTER THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Complete Heart Block

  MAUDE report 8151621 ↗
• InjurySep 11, 2018Perivalvular Leak; Perivalvular Leak

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, SEVERE PARAVALVULAR LEAK (PVL) WAS NOTED. SUBSEQUENTLY, A SECOND VALVE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7865594 ↗
• InjuryMar 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED FOR COMPLETE HEART BLOCK (CHB). NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Complete Heart Block

  MAUDE report 7348120 ↗

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-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-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