CoreValve™ Evolut™ MCS-P3-31-AOARecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169430297), received between Aug 20, 2018 and Feb 12, 2026 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Intravalvular regurgitation” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2026Patient Device Interaction Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 11 YEARS AND 9 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO SEVERE CENTRAL AORTIC REGURGITATION. THE PATIENT SUFFERED EXACERBATION OF CONGESTIVE HEART FAILURE (CHF) AS A RESULT, LEADING TO SIDE EFFECTS OF SHORTNESS OF BREATH AND SWELLING.

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

  MAUDE report 24323567 ↗
• MalfunctionJan 9, 2025Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS 6 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT HAD SEVERE AORTIC STENOSIS (AS) ON THE BIOPROSTHESIS. A VALVE-IN-VALVE (VIV) PROCEDURE WAS PLANNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21118068 ↗
• InjuryOct 9, 2024Calcified; Perivalvular Leak; Thickening of Material; Intravalvular regurgitation; Calcified; Perivalvular Leak; Thickening of Material; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS 12 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE FAILED DUE TO AORTIC INSUFFICIENCY AS IT WAS UNCLEAR IF IT WAS CENTRAL AORTIC REGURGITATION (AR) OR PARAVALVULAR LEAK (PVL). THE LEAFLETS APPEARED THICKENED WITH SOME CALCIFICATION. IT WAS REPORTED THAT THE DEPTH OF THE IMPLANTED VALVE CONTRIBUTED TO THE EVENT. NO TREATMENT HAS BEEN REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT A SECOND, NON-MEDTRONIC VALVE WAS IMPLANTED VALVE-IN-VALVE.

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

  MAUDE report 20404592 ↗
• InjuryAug 21, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS 2 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE FAILED. THE MODE OF FAILURE WAS SEVERE CENTRAL AORTIC REGURGITATION. A TRANSCATHETER AORTIC VALVE (TAV) WAS IMPLANTED VALVE-IN-VALVE THE DAY AFTER ONSET OF SYMPTOMS. FOLLOWING THE PLACEMENT OF THE SECOND VALVE, NO REGURGITATION WAS PRESENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 20020885 ↗
• InjuryApr 2, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT FOUR MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO MOBITZ TYPE II SECOND DEGREE ATRIO-VENTRICULAR (AV) BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 19026864 ↗
• InjuryDec 27, 2023Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY NINE YEARS SIX MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT PRESENTED WITH SEVERE CENTRAL REGURGITATION REPORTED AS "LEAFLET FLAIL". NO INTERVENTION WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18398052 ↗
• InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT ONE DAY FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO UNSPECIFIED ATRIO-VENTRICULAR BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 15893309 ↗
• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 DAY 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 15121762 ↗
• InjurySep 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Complete Heart Block

  MAUDE report 10554263 ↗
• InjurySep 17, 2020Calcified; Perivalvular Leak; Calcified; Perivalvular Leak

  MEDTRONIC RECEIVED INFORMATION THAT SIX YEARS AND SIX DAYS FOLLOWING THE IMPLANT OF THIS 31 MILLIMETER (MM) TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT PRESENTED WITH AORTIC STENOSIS WITH A CALCIFIED NON-CORONARY CUSP VALVE LEAFLET AND MODERATE PARAVALVULAR LEAK. SUBSEQUENTLY, A NON-MEDTRONIC VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Calcium Deposits/Calcification; Insufficiency, Valvular

  MAUDE report 10547454 ↗
• InjuryJan 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT THE DAY FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE A PERMANENT PACEMAKER WAS IMPLANTED DUE TO A LOW EJECTION FRACTION, DYSSYNCHRONY, AND COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Arrhythmia; Complete Heart Block; Low Cardiac Output

  MAUDE report 8258463 ↗
• InjuryDec 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT TWO DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A SINUS NODE DYSFUNCTION WAS REPORTED AND A PERMANENT PACEMAKER WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 8169463 ↗
• InjuryAug 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT ONE DAY FOLLOWING 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 7799456 ↗

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