CoreValve™ Evolut™ MCS-P3-26-AOARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169430259), received between Jun 2, 2017 and Dec 6, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2024Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 10 YEARS, 5 MONTHS, AND 2 WEEKS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, CENTRAL AORTIC REGURGITATION WAS NOTED. THE CENTRAL REGURGITATION WAS OF MODERATE SEVERITY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 20866033 ↗
• MalfunctionAug 12, 2024Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT AORTIC STENOSIS WAS REPORTED. THERE WAS A HIGH RISK FOR CORONARY OCCLUSION AND A VALVE-IN-VALVE MAY BE REQUIRED. MEDICAL MANAGEMENT IS BEING PROVIDED.

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

  MAUDE report 19962835 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Thickening of Material; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Thickening of Material

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE FAILURE MODE WAS REPORTED TO BE LEAFLET THICKENING. THE PATIENT WAS SCHEDULED FOR A VALVE REPLACEMENT, HOWEVER WAS ADMITTED TO THE HOSPITAL FOR ALTERED MENTAL STATUS. THE PATIENT'S FAMILY HAD DECIDED TO BE DNR (DO NOT RESUSCITATE). THEREFORE THE SURGERY IS CANCELLED AND NO INTERVENTION WILL TAKE PLACE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 18476258 ↗
• InjuryMar 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY THREE YEARS AND TEN MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A NON-MEDTRONIC VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO AORTIC STENOSIS CAUSED BY CALCIUM BUILDUP ON THE NON-CORONARY CUSP OF THE INITIAL VALVE. IT WAS REPORTED THAT A DEEPER IMPLANT AND THE PATIENT¿S EXISTING MEDICAL ISSUES AT TIME OF INITIAL IMPLANT LIKELY LED TO VALVE FAILURE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification; Stenosis

  MAUDE report 7328468 ↗
• InjuryJun 2, 2017Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT TWO YEARS AND SEVEN MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT PRESENTED WITH STENOSIS AND INCREASED GRADIENT MEASUREMENTS. THREE DAYS LATER, A SECOND TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED, VALVE-IN-VALVE, AND RESOLVED THE INCREASED GRADIENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 6608317 ↗

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