Evolut™ FX EVOLUTFX-34Recalls & reported problems

Summary

The FDA's MAUDE database contains 563 adverse event reports that list this exact device (DI 00763000370718), received between Aug 10, 2022 and Jul 29, 2026 — classified as 22 deaths, 255 injuries, 286 malfunctions.

The most frequently reported specific device problem is “Material Invagination” (270 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 563 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Patient Device Interaction Problem

  It was reported that, on the same day as the implant of a transcatheter aortic valve, a permanent pacemaker was implanted for complete heart block (CHB).

  Patient problems: Heart Block

  MAUDE report 50070396 ↗
• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 4 DAYS FOLLOWING IMPLANTATION OF A TRANSCATHETER AORTIC VALVE, COMPLETE HEART BLOCK (CHB) OCCURRED AND A PERMANENT PACEMAKER WAS IMPLANTED.

  Patient problems: Heart Block

  MAUDE report 25486832 ↗
• MalfunctionApr 27, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT 2 YEARS AND 10 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE PATIENT EXPERIENCED SHORTNESS OF BREATH (SOB) AND MODERATE CENTRAL REGURGITATION WAS IDENTIFIED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea

  MAUDE report 25008688 ↗
• DeathApr 24, 2026Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT 14 DAYS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO AN UNSPECIFIED CONDUCTION DISTURBANCE. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT LATER DIED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 24979936 ↗
• InjuryApr 8, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT FOLLOWING THE SUCCESSFUL IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE DISLODGED INTO THE ASCENDING AORTA. SUBSEQUENTLY, A NEW VALVE WAS SUCCESSFULLY IMPLANTED AT A DEPTH OF 3 MILLIMETERS (MM).

  Patient problems: Foreign Body In Patient

  MAUDE report 24818201 ↗
• InjuryMar 13, 2026Perivalvular Leak; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE POST-IMPLANT BALLOON DILATION WAS PERFORMED DUE TO MODERATE PVL. THE "LARGE" PVL WAS SP ECIFIED AS MILD-MODERATE SEVERITY. THE PATIENT WAS EXPERIENCING DECREASING EJECTION FRACTION AS A RESULT. THE PLANNED TREATMENT INCLUDED A BALLOON AORTIC VALVULOPLASTY WITH A 28 MM NON-MEDTRONIC BALLOON FIRST AND IF THE PVL REMAINS SIGNIFICANT, A SECOND NON-MEDTRONIC VALVE WILL BE IMPLANTED.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 24590381 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 1 DAY FOLLOWING THE IMPLANT OF AA TRANSCATHETER AORTIC VALVE, THE A PERMANENT PACEMAKER WAS IMPLANTED FOR AN UNSPECIFIED ATRIO-VENTRICULAR (AV) BLOCK AND AN UNSPECIFIED ATRIAL ARRHYTHMIA.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 24444501 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 2 DAYS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED FOR SICK SINUS SYNDROME (SSS) AND AN UNSPECIFIED ATRIO-VENTRICULAR (AV) BLOCK.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 24349424 ↗
• InjuryFeb 12, 2026Fluid/Blood Leak; Perivalvular Leak; Activation Failure; Patient Device Interaction Problem; Intravalvular regurgitation

  IT WAS REPORTED APPROXIMATELY ONE YEAR AND NINE MONTHS FOLLOWING IMPLANT OF THIS 34 MM TRANSCATHETER AORTIC BIOPROSTHETIC VALVE, SIGNIFICANT UNSPECIFIED AORTIC REGURGITATION WAS REPORTED. A PROCTOR REVIEW OF THE DIAGNOSTIC IMAGING WAS PERFORMED AND NOTED THE IMPLANT DEPTH OF THE VALVE FRAME RANGED BETWEEN 6.8 - 7.5MM TO THE NATIVE ANNULUS AND THE VALVE FRAME APPEARED TO BE UNDER-EXPANDED. THE PROCTOR NOTED THE COMPUTED TOMOGRAPHY ANGIOGRAM WAS NOT OF GREAT QUALITY AND HAD GRAINY IMAGES; THEREFORE, WAS DIFFICULT TO DETERMINE WHETHER THE VALVE FRAME WAS APPROXIMATED AGAINST THE ANNULAR TISSUE OR NOT. THE PROCTOR RECOMMENDED VALVE REPLACEMENT WITH A BALLOON-EXPANDABLE VALVE. NO TREATMENT WAS REPORTED AT THIS TIME. NO OTHER PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED TO REPORT THE SEVERITY OF THE AORTIC REGURGITATION WAS MODERATE-SEVERE, AND BOTH CENTRAL AORTIC REGURGITATION AND PARAVALVULAR LEAK (PVL) WERE OBSERVED. IT WAS NOTED THAT THE PATIENT WAS ASYMPTOMATIC. SUBSEQUENTLY, IT WAS PLANNED FOR A VASCULAR PLUG TO BE IMPLANTED FOR PVL CLOSURE. PER THE PHYSICIAN, THE DEPTH OF IMPLANT OF THE VALVE CONTRIBUTED TO THE EVENT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24327250 ↗
• InjuryFeb 5, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 1 DAY FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO SINUS BRADYCARDIA AND ATRIAL ARRHYTHMIAS.

  Patient problems: Arrhythmia; Bradycardia

  MAUDE report 24269138 ↗
• InjuryJan 23, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 1 DAY FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO COMPLETE HEART BLOCK (CHB).

  Patient problems: Heart Block

  MAUDE report 24164550 ↗
• InjuryJan 9, 2026Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE COMPLETE HEART BLOCK OCCURRED INTRAOPERATIVELY.

  Patient problems: Arrhythmia; Heart Block

  MAUDE report 24023310 ↗
• InjuryJan 7, 2026Perivalvular Leak; Patient Device Interaction Problem; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE NYHA CLASS III SYMPTOMS NOTED WAS SPECIFICALLY FATIGUE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Fatigue; Heart Failure/Congestive Heart Failure; Mitral Valve Insufficiency/ Regurgitation; Valvular Insufficiency/ Regurgitation

  MAUDE report 23993365 ↗
• InjuryDec 30, 2025Perivalvular Leak; Patient Device Interaction Problem; Perivalvular Leak; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE SEVERITY OF PVL WAS MODERATE-SEVERE. IT WAS NOTED THAT THERE HAS BEEN NO CHANGE IN SEVERITY SINCE THE INITIAL VALVE IMPLANT AND THE PATIENT WAS NEVER SYMPTOMATIC. HOWEVER, THE PATIENT'S EJECTION FRACTION STARTED TO DECREASE. SUBSEQUENTLY, THE PATIENT WAS SCHEDULED FOR SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 23926902 ↗
• InjuryDec 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 2 DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO AN UNSPECIFIED ATRIO-VENTRICULAR (AV) BLOCK.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23923374 ↗
• MalfunctionDec 23, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 2 YEARS AND 5 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO MODERATE CENTRAL AORTIC REGURGITATION. THE PATIENT IS BEING EVALUATED FOR A POSSIBLE VALVE-IN-VALVE OR EXPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED TO CLARIFY AN INTERVENTION WAS NOT PLANNED OR SCHEDULED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23878807 ↗
• MalfunctionDec 16, 2025Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 2 YEARS AND 3 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, A HIGH MEAN GRADIENT WAS OBSERVED. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED THAT REVEALED THE VALVE FAILED DUE TO AN UNKNOWN REASON. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Transvalvular Pressure Gradient Increased

  MAUDE report 23817952 ↗
• InjuryDec 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 3 DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO COMPLETE HEART BLOCK (CHB) AND ATRIAL ARRYTHMIAS.

  Patient problems: Arrhythmia; Heart Block

  MAUDE report 23789592 ↗
• InjuryDec 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 3 DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO AN UNSPECIFIED ATRIO-VENTRICULAR (AV) BLOCK.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23782211 ↗
• InjuryDec 9, 2025Patient Device Interaction Problem; Device Stenosis; Patient Device Interaction Problem; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 2 YEARS AND 3 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE PATIENT SUFFERED CONGESTIVE HEART FAILURE (CHF) DUE TO SEVERE AORTIC STENOSIS. IT WAS NOTED THAT A VELOCITY OF >500 M/S WAS OBSERVED. THE PATIENT IS SCHEDULED FOR AN EXPLANT.

  Patient problems: Aortic Valve Stenosis; Heart Failure/Congestive Heart Failure

  MAUDE report 23760080 ↗
• MalfunctionDec 5, 2025Material Invagination; Material Invagination

  IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED DUE TO CALCIFICATION. IT WAS NOTED THAT THERE WAS NO MISLOAD IDENTIFIED DURING LOADING. UPON THE FIRST DEPLOYMENT ATTEMPT, AN INFOLD WAS OBSERVED. THE TARGET IMPLANT DEPTH WHEN THE INFOLD OCCURRED WAS 3 MILLIMETERS (MM) ON THE NON-CORONARY CUSP (NCC) AND 3 MM ON THE LEFT CORONARY CUSP (LCC). SUBSEQUENTLY, THE VALVE WAS RECAPTURED AND WITHDRAWN FROM THE PATIENT. A NEW TRANSCATHETER VALVE WAS USED TO COMPLETE THE PROCEDURE. PER THE PHYSICIAN, THE PATIENT'S CALCIFIED ANATOMY CONTRIBUTED TO THE INFOLD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23730393 ↗
• InjuryDec 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 5 DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO COMPLETE HEART BLOCK (CHB).

  Patient problems: Heart Block

  MAUDE report 23716616 ↗
• MalfunctionDec 2, 2025Material Invagination; Material Invagination

  IT WAS REPORTED THAT PRIOR TO THE ATTEMPTED IMPLANT OF A TRANSCATHETER VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED DUE TO THE SIZE OF THE 34 MILLIMETER (MM) VALVE. IT WAS NOTED THAT THERE WAS NO MISLOAD IDENTIFIED DURING LOADING. UPON THE FIRST DEPLOYMENT ATTEMPT, AN INFOLD WAS OBSERVED AND THE VALVE WAS RECAPTURED. IT WAS NOTED THAT THE TARGET IMPLANT DEPTH WHEN THE INFOLD OCCURRED WAS 3 MM. SUBSEQUENTLY, THE SYSTEM WAS WITHDRAWN FROM THE PATIENT. A NEW 34 MM VALVE AND NEW DELIVERY CATHETER SYSTEM (DCS) WERE USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23697721 ↗
• InjuryNov 26, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON THE SAME DAY AS THE IMPLANT OF A TRANSCATHETER VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO COMPLETE HEART BLOCK (CHB).

  Patient problems: Heart Block

  MAUDE report 23657948 ↗
• InjuryNov 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 1 MONTH FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO COMPLETE HEART BLOCK (CHB).

  Patient problems: Heart Block

  MAUDE report 23646785 ↗

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-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-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-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