Evolut™ PRO+ L-EVPROP2329USRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000207892), received between Feb 2, 2021 and Jun 19, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2026Packaging Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, UPON OPENING THE COMPRESSION LOADING SYSTEM (CLS), CONTAMINATION WAS OBSERVED. SUBSEQUENTLY, A NEW CLS AND DELIVERY CATHETER SYSTEM (DCS) WERE OPENED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25562117 ↗
• InjuryFeb 2, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE INTO A PREVIOUSLY IMPLANTED NON MEDTRONIC SURGICAL VALVE, THE VALVE WAS DEPLOYED TO 80% AND THE POSITIONED WAS CONFIRMED TO BE ACCEPTABLE. THE VALVE WAS RELEASED, AND UPON RETRIEVAL OF THE DELIVERY CATHETER SYSTEM (DCS), THE NOSECONE OF THE DCS DISLODGED THE VALVE AORTIC INTO THE UPPER PORTION OF THE SURGICAL VALVE. ECHOCARDIOGRAM SHOWED PARAVALVULAR LEAK (PVL) AND THE VALVE WAS SNARED AND SECURED IN PLACE. A SECOND VALVE WAS PREPPED AND IMPLANTED INTO THE SURGICAL VALVE UNEVENTFULLY. SINGLE DIGIT GRADIENT WITH NO PVL WAS REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 11266969 ↗

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
• 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, Labele
• 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
• 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