CoreValve™ Evolut™ MCS-P3-29-AOARecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00643169430273), received between Dec 19, 2017 and Mar 23, 2026 — classified as 2 deaths, 13 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 2026Patient Device Interaction Problem

  INFORMATION WAS RECEIVED WHICH INDICATED THAT APPROXIMATELY 4.5 MONTHS FOLLOWING THE IMPLANT OF THE TRANSCATHETER BIOPROSTHETIC AORTIC VALVE A CARDIAC RESYNCHRONIZATION DEFIBRILLATOR (CRT-D) WAS IMPLANTED DUE TO A LOW EJECTION FRACTION, DYSSYNCHRONY, AND A WIDE QRS COMPLEX.

  Patient problems: Cardiovascular Dysfunction/Insufficiency; Non specific EKG/ECG Changes

  MAUDE report 24662884 ↗
• InjurySep 11, 2024Calcified; Activation Failure; Patient Device Interaction Problem; Thickening of Material; Intravalvular regurgitation; Calcified; Activation Failure; Patient Device Interaction Problem; Thickening of Material; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 11 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE FAILED DUE TO SEVERE CENTRAL AORTIC REGURGITATION. A 26 MILLIMETER (MM) NON-MEDTRONIC TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE AT NODE 5. NO GRADIENT OR AORTIC REGURGITATION WAS OBSERVED, AND GOOD CORONARY FLOW WAS CONFIRMED. IT WAS NOTED THAT THE DEPTH OF IMPLANT CONTRIBUTED TO THE AORTIC REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Calcium Deposits/Calcification; Corneal Pannus; Thrombosis/Thrombus

  MAUDE report 20193161 ↗
• InjurySep 11, 2024Calcified; Activation Failure; Patient Device Interaction Problem; Thickening of Material; Intravalvular regurgitation; Calcified; Activation Failure; Patient Device Interaction Problem; Thickening of Material; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 9 YEARS AND 11 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, SEVERE AORTIC REGURGITATION, LEAFLET CALCIFICATION, THROMBUS FORMATION AND PANNUS FORMATION WERE NOTED. ADDITIONALLY, FRAME UNDER EXPANSION WAS OBSERVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Corneal Pannus; Thrombosis/Thrombus

  MAUDE report 20191916 ↗
• InjuryApr 8, 2024Perivalvular Leak; Patient Device Interaction Problem; Device Stenosis; Perivalvular Leak; Patient Device Interaction Problem; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THAT 9 YEARS AND 11 MONTHS FOLLOWING THE VALVE IMPLANT, THE VALVE FAILED. 10 YEARS FOLLOWING THE VALVE IMPLANT, SEVERE PARAVALVULAR LEAK (PVL) WAS OBSERVED. A PRE-IMPLANT DILATION WAS PERFORMED REDUCING THE (PVL) TO MODERATE. SUBSEQUENTLY A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE. POST MEAN GRADIENT OF 3 MILLIMETERS OF MERCURY (MMHG) WAS REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Hemodynamic instability; Valvular Insufficiency/ Regurgitation

  MAUDE report 19059487 ↗
• InjuryOct 11, 2023Gradient Increase; Intravalvular regurgitation; Gradient Increase; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT NINE YEARS, FOUR MONTHS, AND TWENTY-FOUR DAYS POST-IMPLANT, A SECOND NON-MEDTRONIC VALVE WAS IMPLANTED VALVE-IN-VALVE SUCCESSFULLY. NO COMPLICATIONS WERE REPORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 17916117 ↗
• InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 9 YEARS 1 MONTH FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, SEVERE AORTIC STENOSIS WAS OBSERVED DUE TO STRUCTURAL VALVE DETERIORATION. IT WAS REPORTED THAT THE PATIENT WILL RECEIVE A NON-MEDTRONIC VALVE IMPLANTED VALVE-IN-VALVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 17788921 ↗
• DeathAug 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT ON THE DAY OF IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE ((B)(6)), A SECOND VALVE WAS IMPLANTED (SN (B)(6)) FOR AN UNKNOWN REASON. A THIRD VALVE WAS THEN IMPLANTED (SN (B)(6)), ALSO FOR AN UNKNOWN REASON. THE PATIENT DIED 1 YEAR AND 3 MONTHS POST-OPERATION. THE CAUSE OF DEATH IS UNKNOWN. FURTHER INFORMATION COULD NOT BE OBTAINED.

  Patient problems: Insufficient Information

  MAUDE report 17568372 ↗
• InjuryAug 9, 2023Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT FIVE YEARS AND FIVE MONTHS FOLLOWING THE IMPLANT OF THESE TRANSCATHETER BIOPROSTHETIC VALVES, THE VALVES WERE REPLACED WITH A PERICARDIAL TISSUE HEART VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17487935 ↗
• InjuryDec 8, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT EIGHT YEARS AND ONE MONTH POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT WAS EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. SUBSEQUENTLY, A NON-MEDTRONIC (MANUFACTURER UNKNOWN) VALVE WAS IMPLANTED ON AN UNKNOWN DATE. NO FURTHER INFORMATION WAS PROVIDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15945868 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 7 YEARS AND 5 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT HAD SHORTNESS OF BREATH AND IT WAS NOTED THAT THERE WAS AORTIC STENOSIS WITH A GRADIENT OF 39 MM HG, AORTIC VALVE AREA OF .4 CM2, AND A VELOCITY OF 4.2 M/S. THE VALVE APPEARED TO HAVE BEEN IMPLANTED DEEP. SUBSEQUENTLY A 23 MM NON-MEDTRONIC VALVE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 13601472 ↗
• DeathJul 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT FIVE YEARS, NINE MONTHS AND TWENTY SIX DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT WAS PLACED ON A VENTILATOR DUE TO SEVERE AORTIC STENOSIS AND AORTIC REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Regurgitation; Aortic Valve Stenosis; Congestive Heart Failure; Death; Fever; Hypoxia; Regurgitation, Valvular; Sepsis; Ventilator Dependent

  MAUDE report 10271837 ↗
• InjuryFeb 4, 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, AN UNSPECIFIED ATRIO-VENTRICULAR (AV) BLOCK WAS REPORTED AND A PERMANENT PACEMAKER WAS IMPLANTED. APPROXIMATELY FIVE YEARS AND EIGHT MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A NEW VALVE WAS IMPLANTED IN VALVE-IN-VALVE FOR AN UNKNOWN REASON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 9667315 ↗
• InjuryMar 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT TWO DAYS AFTER THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO ATRIO-VENTRICULAR (AV) BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 8398796 ↗
• InjuryJul 13, 2018Backflow; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY THREE YEARS AND NINE MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO SEVERE CENTRAL AORTIC REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Regurgitation; No Code Available

  MAUDE report 7684915 ↗
• InjuryDec 19, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A SECOND TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED FOR AN UNKNOWN REASON. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7129162 ↗

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