Evolut™ FX EVOLUTFX-29Recalls & reported problems

Summary

The FDA's MAUDE database contains 564 adverse event reports that list this exact device (DI 00763000370701), received between Aug 10, 2022 and Aug 24, 2026 — classified as 47 deaths, 401 injuries, 116 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (251 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 564 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2026Material Invagination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50409379 ↗
• InjuryAug 14, 2026Patient Device Interaction Problem

  It was reported that approximately 3 years and 4 months following the implant of a transcatheter aortic valve, endocarditis was identified. Subsequently, the valve was explanted, and a surgical aortic valve was implanted.

  Patient problems: Endocarditis

  MAUDE report 50254435 ↗
• InjuryJun 17, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 4 DAYS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED FOR AN ATRIO-VENTRICULAR (AV) BLOCK OF UNSPECIFIED SEVERITY.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 25534762 ↗
• MalfunctionJun 2, 2026Gradient Increase; Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis

  IT WAS REPORTED THAT 2 YEARS AND 7 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, AN UNSPECIFIED VALVE FAILURE OCCURRED.

  Patient problems: Hemodynamic instability; Insufficient Information

  MAUDE report 25365489 ↗
• MalfunctionMay 13, 2026Perivalvular Leak; Patient Device Interaction Problem; Migration

  IT WAS REPORTED THAT APPROXIMATELY 3 YEARS AND 4 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, IT WAS OBSERVED THE VALVE HAD MIGRATED, RESULTING IN PARAVALVULAR LEAK (PVL) OF UNSPECIFIED SEVERITY AND CONGESTIVE HEART FAILURE (CHF).

  Patient problems: Heart Failure/Congestive Heart Failure; Valvular Insufficiency/ Regurgitation

  MAUDE report 25163679 ↗
• InjuryMay 8, 2026Calcified; Perivalvular Leak

  IT WAS REPORTED THAT APPROXIMATELY 2 YEARS AND 1 MONTH FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, MODERATE PARAVALVULAR LEAK (PVL) WAS OBSERVED. SUBSEQUENTLY, A 12 MILLIMETER (MM) PVL PLUG WAS IMPLANTED. FOLLOWING THE PLACEMENT OF THE PLUG, IT WAS OBSERVED THAT THE SEVERITY OF THE PVL HAD BEEN REDUCED TO TRACE. IT WAS NOTED THAT EXTENSIVE LEAFLET AND LEFT VENTRICULAR OUTFLOW TRACT (LVOT) CALCIFICATION LIKELY CONTRIBUTED TO THE PVL.

  Patient problems: Calcium Deposits/Calcification; Valvular Insufficiency/ Regurgitation

  MAUDE report 25126072 ↗
• InjuryApr 11, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 1 DAY FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED FOR CLASS 3 HEART FAILURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24846348 ↗
• InjuryApr 3, 2026Perivalvular Leak; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE WIRE USED DURING THE IMPLANT OF THE VASCULAR PLUG WAS A NON-MEDTRONIC GUIDEWIRE. PER THE PHYSICIAN, THE NON-MEDTRONIC GUIDEWIRE WAS BELIEVED TO BE THE CAUSE OF THE EFFUSION.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Heart Failure/Congestive Heart Failure; Hemodynamic instability; Pleural Effusion

  MAUDE report 24781732 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

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

  Patient problems: Heart Block

  MAUDE report 24746059 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED FOR COMPLETE HEART BLOCK (CHB).

  Patient problems: Heart Block

  MAUDE report 24664210 ↗
• InjuryMar 4, 2026Perivalvular Leak; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 1 YEAR AND 8 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO SEVERE PARAVALVULAR LEAK (PVL). THE PATIENT SUFFERED HEART FAILURE AND HEMODYNAMIC INSTABILITY AS A RESULT.

  Patient problems: Heart Failure/Congestive Heart Failure; Hemodynamic instability; Valvular Insufficiency/ Regurgitation

  MAUDE report 24514025 ↗
• InjuryFeb 26, 2026Fluid/Blood Leak; Perivalvular Leak

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE MODERATE-SEVERE AORTIC REGURGITATION OBSERVED DURING THE MRI WAS PARAVALVULAR LEAK (PVL). THE PATIENT WAS SCHEDULED FOR A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AT A LATER DATE TO DETERMINE THE TREATMENT PLAN.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Valvular Insufficiency/ Regurgitation

  MAUDE report 24458971 ↗
• InjuryFeb 25, 2026Patient Device Interaction Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED CONSERVATIVE TREATMENT INCLUDED OBSERVATION OF THE PATIENT DURING ADMISSION.

  Patient problems: Chest Pain; Myocardial Infarction; Non specific EKG/ECG Changes; Thromboembolism; Thrombosis/Thrombus

  MAUDE report 24442914 ↗
• InjuryFeb 18, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 6 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 24377554 ↗
• MalfunctionFeb 16, 2026Fluid/Blood Leak; Gradient Increase; Perivalvular Leak; Mechanics Altered; Thickening of Material; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT 3 YEARS AND 5 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, VALVE STENOSIS WAS IDENTIFIED.

  Patient problems: Aortic Valve Stenosis; Dyspnea; Fatigue; Mitral Valve Insufficiency/ Regurgitation; Transvalvular Pressure Gradient Increased; Tricuspid Valve Insufficiency/ Regurgitation; Valvular Insufficiency/ Regurgitation

  MAUDE report 24345408 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE SAME DAY A TRANSCATHETER AORTIC VALVE WAS IMPLANTED, A PERMANENT PACEMAKER WAS IMPLANTED FOR 2ND DEGREE ATR IO-VENTRICULAR (AV) BLOCK.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 24284559 ↗
• InjuryFeb 6, 2026Patient Device Interaction Problem

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

  Patient problems: Heart Block

  MAUDE report 24283969 ↗
• InjuryJan 28, 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). ADDITIONAL INFORMATION WAS RECEIVED THAT THE CHB OCCURRED ON THE SAME DAY AS THE VALVE IMPLANT FOLLOWING THE PROCEDURE.

  Patient problems: Heart Block

  MAUDE report 24202912 ↗
• DeathJan 28, 2026Insufficient Device Problem Information; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE DELIVERY CATHETER SYSTEM (DCS) WAS PULLED, CAUSING THE NOSECONE TO DISLODGE THE IMPLANTED VALVE AND THE PATIENT TO DECOMPENSATE. AN ADDITIONAL VALVE WAS IMPLANTED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE IMPLANT OF THE VALVE, THE RIGHT FEMORAL ARTERY WAS USED FOR THE ACCESS SITE. NO PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED. A NON-MEDTRONIC GUIDEWIRE (SAFARI) WAS USED DURING THE IMPLANT. THE VALVE WAS IMPLANTED INTO THE NATIVE ANNULUS. CUSPAL OVERLAP TECHNIQUE WAS USED ALONG WITH SLOW DEPLOYMENT TRAINING GUIDANCE. IT WAS REPORTED THAT THE NOSECONE WAS NOT CENTERED WITHIN THE VALVE FRAME INFLOW PRIOR TO WITH DRAWING THE DELIVERY CATHETER SYSTEM (DCS). THE DCS WAS NOT TWISTED OR TORQUED DURING DEPLOYMENT. HYPOTENSION WAS OBSERVE WHEN THE PATIENT DECOMPENSATED AND THEY WERE PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT FAMILY MEMBER REPORTING IT WAS A BAD EXPERIENCE WITH PUTTING IN T

  Patient problems: Foreign Body In Patient; Heart Block

  MAUDE report 24202316 ↗
• InjuryJan 9, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE INVOLVING A TRANSCATHETER AORTIC VALVE REPLACEMENT, EVIDENCE OF HEART BLOCK PRESENTED. ONE DAY LATER, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO COMPLETE HEART BLOCK (CHB). PER THE PHYSICIAN, THE CHB WAS POSSIBLY RELATED TO THE IMPLANT PROCEDURE, BUT NOT RELATED TO THE VALVE.

  Patient problems: Heart Block

  MAUDE report 24021986 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED FOR AN UNSPECIFIED A TRIO-VENTRICULAR (AV) BLOCK.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23984283 ↗
• InjuryDec 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 3 WEEKS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE WAS EXPLANTED DUE TO AN UNSPECIFIED INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23910038 ↗
• InjuryDec 21, 2025Gradient Increase; Perivalvular Leak; Intravalvular regurgitation; Gradient Increase; Perivalvular Leak; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT FOLLOWING THE REDO TAV IMPLANT, THE MEAN GRADIENT WAS 6 MMHG.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information; Mitral Valve Insufficiency/ Regurgitation; Transvalvular Pressure Gradient Increased; Tricuspid Valve Insufficiency/ Regurgitation; Valvular Insufficiency/ Regurgitation

  MAUDE report 23860474 ↗
• InjuryDec 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED 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 23839349 ↗
• InjuryDec 9, 2025Fluid/Blood Leak; Gradient Increase; Patient Device Interaction Problem; Thickening of Material; Device Stenosis; Fluid/Blood Leak; Gradient Increase; Patient Device Interaction Problem; Thickening of Material; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 9 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE PATIENT DEVELOPED ENDOCARDITIS THAT WAS CONFIRMED. SUBSEQUENTLY, THE PATIENT WAS TREATED FOR ENDOCARDITIS AT THAT TIME; HOWEVER, THE PATIENT HAS HAD CONTINUED DYSPNEA. AN UNSPECIFIED AMOUNT OF TIME FOLLOWING THE IMPLANT OF THE VALVE AN ECHOCARDIOGRAM WAS PERFORMED THAT REVEALED AORTIC STENOSIS (AS) AND MILD AORTIC INSUFFICIENCY (AI).

  Patient problems: Aortic Valve Stenosis; Dyspnea; Endocarditis; Heart Failure/Congestive Heart Failure; Swelling/ Edema; Transvalvular Pressure Gradient Increased; Valvular Insufficiency/ Regurgitation

  MAUDE report 23759554 ↗

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