Evolut™ FX L-EVOLUTFX-2329 (UDI 00763000365691)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000365691), received between Jul 7, 2025 and Jan 26, 2026 — classified as 2 injuries.

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 18, 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.

• InjuryJan 26, 2026Device Dislodged or Dislocated; No Apparent Adverse Event

  IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED DUE TO THE PATIENT'S THICKENED LEAFLETS. FOLLOWING THE SUCCESSFUL DEPLOYMENT OF THE VALVE, UPON THE REMOVAL OF THE DELIVERY CATHETER SYSTEM (DCS), THE NOSE CONE CAUGHT ON THE VALVE FRAME, RESULTING IN DISLODGEMENT OF THE VALVE. SUBSEQUENTLY, A NEW VALVE AND DCS WERE PREPPED. UPON THE FIRST DEPLOYMENT ATTEMPT WITH THE SECOND SYSTEM, THE VALVE WAS UNABLE TO BE POSITIONED SECURELY AND WAS SUBSEQUENTLY RECAPTURED. TWO FURTHER DEPLOYMENT ATTEMPTS WERE MADE, HOWEVER THE VALVE REMAINED UNABLE TO BE SECURELY POSITIONED. SUBSEQUENTLY, THE PROCEDURE WAS ULTIMATELY ABORTED. PER THE PHYSICIAN, THE PATIENT'S TORTUOUS ANATOMY INCLUDING A 70 DEGREE ROOT ANGLE, SHORT AORTIC ROOT, AND LEAFLET CALCIFICATION CONTRIBUTED TO THE DISLODGE AND THE DIFFICULTIES PLACING THE SECOND VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183906 ↗
• InjuryJul 7, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED DUE TO CALCIFICATION. DURING THE FIRST ADVANCEMENT ATTEMPT, THE VALVE WAS ADVANCED THROUGH THE RIGHT FEMORAL ARTERY (RFA) USING AN INLINE SHEATH; HOWEVER, WHEN IT REACHED THE RIGHT EXTERNAL ILIAC ARTERY, IT WAS UNABLE TO ADVANCE. SUBSEQUENTLY, THE VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE WITHDRAWN AND ANGIOPLASTY AND SHOCKWAVE THERAPY WERE PERFORMED ON THE RIGHT EXTERNAL ILIAC VESSEL. A SECOND ADVANCEMENT ATTEMPT WITH THE SAME VALVE AND DCS WAS THEN PERFORMED BUT WAS UNSUCCESSFUL; THEREFORE, THE VALVE WAS WITHDRAWN. THE ACCESS SITE WAS THEN SWITCHED TO THE LEFT FEMORAL ARTERY (LFA), AND A NEW VALVE AND DCS WERE ADVANCED THROUGH A NON-MEDTRONIC SHEATH AND USED TO COMPLETE THE PROCEDURE. IT WAS NOTED THAT A 30-MINUTE PROCEDURAL DELAY OCCURRED AS A RESULT OF THE EVENT. PER THE PHYSICIAN, THE PATIENT¿S CALCIFIED ANATOMY CONTRIBUTED TO THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE DCS WAS LOADED APPROXIMATELY 30 MINUTES PRIOR TO THE FIRST ADVANCEMENT ATTEMPT. OF NOTE, NO MISLOAD WAS IDENTIFIED. ADDITIONAL TIME WAS SPENT ATTEMPTING T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22418362 ↗

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