CoreValve™ Evolut™ MCS-P3-31-AOA-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00643169448551), received between Jun 22, 2015 and Mar 20, 2026 — classified as 59 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (14 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 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 10 YEARS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO AN UNSPECIFIED CAUSE. THE PATIENT IS BEING EVALUATED FOR POTENTIAL TREATMENT OPTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650479 ↗
• InjuryMar 17, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 10 YEARS AND 3 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE WAS INACTIVATED FOR AN UNSPECIFIED REASON. SUBSEQUENTLY, A SECOND VALVE WAS IMPLANTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617743 ↗
• InjuryJan 30, 2026Insufficient Device Problem Information

  IT WAS REPORTED APPROXIMATELY 8 YEARS AND 1 MONTH FOLLOWING THE IMPLANT OF THIS TRANSCATHETER AORTIC VALVE, THE VALVE WAS EXPLANTED FOR AN UNKNOWN REASON. SUBSEQUENTLY, A SURGICAL TISSUE VALVE WAS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 24225398 ↗
• MalfunctionNov 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 10 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, UNSPECIFIED VALVE FAILURE WAS OBSERVED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631485 ↗
• InjuryAug 28, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, VENTRICULAR FIBRILLATION WAS REPORTED AND CARDIOVERSION WAS PERFORMED ONCE. FOLLOWING THE VALVE IMPLANT PROCEDURE, LEFT BUNDLE BRANCH BLOCK (LBBB) AND SINUS BRADYCARDIA WERE NOTED. A TEMPORARY PACING WIRE WAS PLACED AND MEDICATION WAS ADJUSTED. HYPOTENSION WAS REPORTED DUE TO VOLUME DEPLETION AND PRESSORS WERE PRESCRIBED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS REPORTED THAT NO TREATMENT WAS PROVIDED FOR THE LBBB. PER THE PHYSICIAN, THE LBBB WAS RELATED TO THE VALVE AND VALVE IMPLANT PROCEDURE. APPROXIMATELY SIX MONTHS FOLLOWING ONSET, THE LBBB RESOLVED, WITHOUT SEQUELAE. ADDITIONAL INFORMATION WAS REPORTED THAT A PERMANENT PACEMAKER WAS IMPLANTED THREE DAYS FOLLOWING THE IMPLANT OF THE VALVE FOR BRADYCARDIA. BRADYCARDIA RESOLVED WITH NO SEQUELAE ONE DAY FOLLOWING THE IMPLANT OF THE PERMANENT PACEMAKER. PER THE PHYSICIAN, THE BRADYCARDIA EVENT WAS RELATED TO THE VALVE AND THE VALVE IMPLANT PROCEDURE.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes; Ventricular Fibrillation

  MAUDE report 22915018 ↗
• InjuryJun 13, 2025Fluid/Blood Leak; Gradient Increase; Perivalvular Leak; Fluid/Blood Leak; Gradient Increase; Perivalvular Leak

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT UNSPECIFIED REGURGITATION WAS ALSO PRESENT. AN UNSPECIFIED VALVE INTERVENTION OCCURRED APPROXIMATELY 2 MONTHS FOLLOWING ONSET OF THIS EVENT. HOSPITALIZATION WAS REQUIRED.

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

  MAUDE report 22202491 ↗
• MalfunctionJun 2, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 10 YEARS AND 1 MONTH FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE VALVE FAILED DUE TO STENOSIS. SUBSEQUENTLY, THE PATIENT WAS BEING EVALUATED FOR A TAV-IN-TAV OR EXPLANT PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Stenosis

  MAUDE report 22125938 ↗
• InjuryJan 8, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 9 YEARS AND 4 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, VALVE STENOSIS WAS NOTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT A NON-MEDTRONIC VALVE WAS IMPLANTED VALVE-IN-VALVE AS TREATMENT FOR THE STENOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106207 ↗
• MalfunctionJan 7, 2025Thickening of Material; Device Stenosis; Thickening of Material; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT SEVEN YEARS AND EIGHT MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT WAS EVALUATED FOR A TRANSCATHETER VALVE REPLACEMENT. IT WAS NOTED THE VALVE WAS FAILING DUE TO STENOSIS AND LIKELY HYPOATTENUATING LEAFLET THICKENING. NO TREATMENT WAS REPORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21093704 ↗
• InjuryJan 2, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 8 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER AORTIC VALVE, VALVE STENOSIS WAS NOTED. A TRANSCATHETER AORTIC VALVE-IN-VALVE PROCEDURE WITH A NON-MEDTRONIC VALVE WAS PLANNED AS TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057820 ↗
• InjuryNov 19, 2024Device Stenosis; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE WAS EXPLANTED DUE TO SEVERE AORTIC STENOSIS. A SURGICAL VALVE WAS SUBSEQUENTLY IMPLANTED.

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

  MAUDE report 20727643 ↗
• InjuryOct 2, 2024Perivalvular Leak; Patient Device Interaction Problem; Perivalvular Leak; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THE PHYSICIAN ASSESSED THE SECOND VALVE¿S MILD TO MODERATE PVL AS RELATED TO THE VALVE AND NOT RELATED TO THE VALVE IMPLANT PROCEDURE.

  Patient problems: Atrial Fibrillation; Heart Failure/Congestive Heart Failure; Non specific EKG/ECG Changes; Pulmonary Dysfunction; Swelling/ Edema; Tachycardia; Thrombocytopenia; Valvular Insufficiency/ Regurgitation

  MAUDE report 20352612 ↗
• InjurySep 12, 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 SEVEN DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A BIVENTRICULAR DEFIBRILLATOR WAS IMPLANTED DUE TO A LOW EJECTION FRACTION AND DYSSYNCHRONY WITH A WIDE QRS INTERVAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 20199844 ↗
• InjurySep 6, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN AMOUNT OF TIME FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE FAILED. THE MECHANISM OF FAILURE WAS CENTRAL AORTIC REGURGITATION (AR). A SECOND VALVE WAS PLACED AS TREATMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 20155351 ↗
• InjurySep 6, 2024Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS 8 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE FAILED. THE MECHANISM OF FAILURE WAS NOT REPORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 20155292 ↗
• InjuryApr 10, 2024Device Stenosis; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE WAS EXPLANTED APPROXIMATELY EIGHT YEARS POST VALVE IMPLANT.

  Patient problems: Aortic Valve Stenosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19077050 ↗
• MalfunctionMar 27, 2024Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE FAILURE WAS AORTIC STENOSIS.

  Patient problems: Aortic Valve Stenosis; Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18988267 ↗
• InjuryDec 21, 2023Adverse 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 4 DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT HAD ATRIAL ARRHYTHMIA WHICH NECESSITATED THE IMPLANT OF A PERMANENT PACEMAKER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Arrhythmia

  MAUDE report 18377000 ↗
• InjuryDec 8, 2023Fluid/Blood Leak; Patient Device Interaction Problem; Fluid/Blood Leak; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 7 YEARS, 11 AND A HALF MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINT OF SHORTNESS OF BREATH AND FATIGUE. DIAGNOSTIC TESTING INCLUDED A SCHEDULED NON-CONTRAST COMPUTED TOMOGRAPHY AND A TRANSTHORACIC ECHOCARDIOGRAM TO RULE OUT STENOSIS AND THROMBOSIS OF THE DISLODGED VALVE. REVIEW OF THE TRANSTHORACIC ECHOCARDIOGRAM SHOWED LT VENTRICLE: MODERATE CONCENTRIC HYPERTROPHY. ESTIMATED EJECTION FRACTION WAS (B)(4). VENTRICULAR PACING FROM THE PERMANENT PACEMAKER. LEFT ATRIUM: SEVERELY DILATED. RT ATRIUM: MODERATELY DILATED. MILD TRICUSPID REGURGITATION. TRIVIAL MITRAL REGURGITATION. TRANSVALVULAR VELOCITY WAS WITHIN NORMAL VALVE LIMITS. THE AORTIC VALVE STRUCTURE AND FUNCTION WERE NORMAL, NO EVIDENCE OF STENOSIS; THERE WAS NO VALVULAR INSUFFICIENCY OR PARAVALVULAR LEAK. LABORATORY RESULTS FROM BLOOD TESTS SHOWED THE WHITE BLOOD CELL (WBC) COUNT, BLOOD UREA NITROGEN (BUN), CREATININE, ASPARTATE AMINOTRANSFERASE (AST), INTERNATIONAL NORMALIZED RATIO (INR), CREATINE KINASE (CK), AND TROPONIN WERE ABOVE NORMAL LIMITS AT ADMISSION. SUBSEQUENTLY, THE PATIENT

  Patient problems: Cardiac Enzyme Elevation; Dyspnea; Fatigue; Heart Failure/Congestive Heart Failure; High Blood Pressure/ Hypertension; Mitral Valve Insufficiency/ Regurgitation; Myocardial Hypertrophy; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 18293173 ↗
• InjuryNov 8, 2023Patient Device Interaction Problem; Intravalvular regurgitation; Patient Device Interaction Problem; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DEVELOPED SEVERE CENTRAL AORTIC REGURGITATION, AND THE PATIENT WAS SUBSEQUENTLY PLACED ON A VENTILATOR. IT WAS NOTED THAT THE ONSET WAS ABRUPT. THE PATIENT WENT FROM NO REGURGITATION TO SEVERE REGURGITATION. NO INTERVENTION WAS PERFORMED, AND THE PATIENT WAS PLACED IN HOSPICE CARE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 18092011 ↗
• MalfunctionOct 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT EIGHT YEARS AND ONE MONTH FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER AORTIC VALVE (TAV)-IN-TAV PROCEDURE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17953065 ↗
• InjuryOct 10, 2023Adverse 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 FOUR DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO AN UNSPECIFIED/INCOMPLETE ATRIO-VENTRICULAR BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 17904041 ↗
• InjuryJul 19, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT EIGHT YEARS AND SIX MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT WAS EVALUATED FOR A TRANSCATHETER VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS DUE TO AN UNSPECIFIED VALVE FAILURE. A NON-MEDTRONIC VALVE WAS SUBSEQUENTLY IMPLANTED VALVE IN VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17350515 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT FIVE DAYS 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: Heart Block

  MAUDE report 16724418 ↗
• InjurySep 8, 2022Degraded; Degraded

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS 11 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT WAS IMAGED FOR SEVERE STENOSIS. THE VALVE WAS REPLACED, VALVE IN VALVE WITH A 31 MM NON-MEDTRONIC TRANSCATHETER VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 15383951 ↗

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