Evolut™ FX L-EVOLUTFX-2329 (UDI 00763000942724)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000942724), received between Jul 9, 2025 and Jul 9, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Packaging Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2025Packaging Problem; No Apparent Adverse Event; Packaging Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT AFTER OPENING THE DELIVERY CATHETER SYSTEM (DCS) AND COMPRESSION LOADING SYSTEM (CLS), AND WHILE PREPARING TO LOAD THE SYSTEM, A HAIR WAS OBSERVED TO BE ATTACHED TO THE CLS WHEN COLD WATER WAS ADDED. SUBSEQUENTLY, A NEW CLS WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED IN CONNECTION WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE CLS STERILITY WAS COMPROMISED DUE TO USER ERROR. THE DCS STERILITY WAS NOT COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22461483 ↗

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-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-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-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