Evolut™ FX EVOLUTFX-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 00763000370688), received between Aug 10, 2022 and Aug 30, 2026 — classified as 11 deaths, 74 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (40 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 106 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2026Insufficient Device Problem Information; Intravalvular regurgitation

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 50513073 ↗
• MalfunctionAug 24, 2026Gradient Increase; Patient Device Interaction Problem

  Patient problems: Heart Failure/Congestive Heart Failure; Transvalvular Pressure Gradient Increased

  MAUDE report 50411522 ↗
• InjuryJul 30, 2026Gradient Increase; Patient Device Interaction Problem; Thickening of Material; Device Stenosis

  It was reported that approximately 1 year and 2 months following the implant of a transcatheter aortic valve, an echocardiogram was performed revealing moderate aortic stenosis and a mean gradient of 30 millimeters of mercury (mmHg). Approximately 4 days later, the patient reported increased shortness of breath. Approximately 4 months later, a computed tomography (CT) scan was performed, demonstrating hypoattenuated leaflet thickening (HALT). An echocardiogram was performed the following day revealing the mean gradient had increased to 35 mmHg. Approximately one month later, the patient was hospitalized due to shortness of breath and increased work of breathing, where they were diagnosed with congestive heart failure (CHF). The patient was started on anti-coagulation medicine, andwill return for a repeat echocardiogram to evaluate for potential further treatment options.

  Patient problems: Aortic Valve Stenosis; Dyspnea; Heart Failure/Congestive Heart Failure; Transvalvular Pressure Gradient Increased

  MAUDE report 50087326 ↗
• MalfunctionMay 7, 2026Gradient Increase; Perivalvular Leak; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED THAT APPROXIMATELY 2 YEARS FOLLOWING THE IMPLANT OF THIS VALVE, AN ECHOCARDIOGRAM WAS PERFORMED THAT REVEALED A MEAN AORTIC VALVE GRADIENT OF 16 MILLIMETERS OF MERCURY (MM HG), PEAK VELOCITY OF 2.8 METERS PER SECOND (M/S), AORTIC VALVE AREA OF 2.36 SQUARED CENTIMETERS, MILD TO MODERATE TRICUSPID REGURGITATION, AND A 29 MILLIMETER (MM) BIOPROSTHETIC MITRAL VALVE WITH A MITRAL VALVE GRADIENT OF 8 MM HG AND TRACE MITRAL REGURGITATION. APPROXIMATELY 2 YEARS AND 11 MONTHS FOLLOWING THE IMPLANT OF THE VALVE, ANOTHER ECHOCARDIOGRAM WAS PERFORMED THAT REVEALED WORSENING VELOCITY AND GRADIENTS WITH A MEAN GRADIENT OF 34 MM HG, MAX VELOCITY OF 3.9 M/S, AND AT LEAST MODERATE PARAVALVULAR LEAK (PVL) RESPONSIBLE FOR THESE FINDINGS.

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

  MAUDE report 25112583 ↗
• InjuryJan 9, 2026Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CHB FIRST OCCURRED 1 DAY POST IMPLANT.

  Patient problems: Heart Block

  MAUDE report 24027699 ↗
• InjuryDec 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT COMPLETE HEART BLOCK (CHB) WITH NO ESCAPE RHYTHM OCCURRED DURING DEPLOYMENT.

  Patient problems: Heart Block

  MAUDE report 23818063 ↗
• InjuryDec 15, 2025Gradient Increase; Patient Device Interaction Problem; Device Stenosis; Gradient Increase; Patient Device Interaction Problem; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 1 YEAR AND 10 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE PATIENT WAS HOSPITALIZED DUE TO CONGESTIVE HEART FAILURE (CHF) WITH A MEAN GRADIENT OF 40  MILLIMETERS OF MERCURY (MM HG). A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED THAT REVEALED THE VALVE FAILED DUE TO AORTIC STENOSIS. SUBSEQUENTLY, THE PATIENT WAS EVALUATED FOR A POSSIBLE BALLOON AORTIC VALVULOPLASTY (BAV), OR TRANSCATHETER AORTIC VALVE-IN-TRANSCATHETER AORTIC VALVE REPLACEMENT.

  Patient problems: Heart Failure/Congestive Heart Failure; Transvalvular Pressure Gradient Increased; Valvular Stenosis

  MAUDE report 23800011 ↗
• InjuryNov 25, 2025Perivalvular Leak; Perivalvular Leak

  ADDITIONAL INFORMATION WAS RECEIVED THAT A BALLOON AORTIC VALVULOPLASTY WAS PERFORMED USING AN 18 MM NON-MEDTRONIC BALLOON TO TREAT THE MODERATE PVL. THE PVL IMPROVED, BUT THE PATIENT WAS SUBSEQUENTLY SCHEDULED FOR AN ECHOCARDIOGRAM.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 23645725 ↗
• MalfunctionNov 23, 2025Gradient Increase; Insufficient Device Problem Information; Patient Device Interaction Problem; Thickening of Material; Device Stenosis; Gradient Increase; Insufficient Device Problem Information; Patient Device Interaction Problem; Thickening of Material; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE VALVE FAILED DUE TO SEVERE PROSTHETIC AORTIC STENOSIS. TWO MONTHS FOLLOWING THE VALVE IMPLANT, A VALVE GRADIENT OF 31 MILLIMETERS OF MERCURY (MM HG) WAS OBSERVED. MEDICATION WAS ADMINISTERED AND TWO MONTHS LATER, THE VALVE GRADIENT AND DECREASED TO21 MMHG. APPROXIMATELY ONE YEAR AND ONE MONTH FOLLOWING THE VALVE IMPLANT, A VALVE GRADIENT OF 40 MMHG WAS OBSERVED. NO TREATMENT WAS REPORTED. IT WAS NOTED THAT THE VALVE WAS IMPLANTED VALVE-IN-VALVE INTO A PREVIOUSLY IMPLANTED NON-MEDTRONIC SURGICAL VALVE.

  Patient problems: Aortic Valve Stenosis; Foreign Body Reaction; Thrombosis/Thrombus; Transvalvular Pressure Gradient Increased

  MAUDE report 23627931 ↗
• InjuryNov 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

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

  Patient problems: Heart Block

  MAUDE report 23507303 ↗
• InjuryAug 27, 2025Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT APPROXIMATELY 2 YEARS AND 8 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED WHICH REVEALED A HIGH GRADIENT AND THROMBOSIS. SUBSEQUENTLY, DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED AND FOLLOW UP WILL BE CONDUCTED.

  Patient problems: Transvalvular Pressure Gradient Increased

  MAUDE report 22902782 ↗
• InjuryJul 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 2 YEARS AND 6 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE WAS EXPLANTED FOR AN UNKNOWN REASON AND A SURGICAL TISSUE VALVE WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494740 ↗
• MalfunctionMay 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE VALVE FAILED DUE TO AN UNKNOWN REASON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005451 ↗
• InjuryApr 21, 2025Gradient Increase; Activation Failure; Device Stenosis; Gradient Increase; Activation Failure; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 1 YEAR, 7 MONTHS, AND 3 WEEKS FOLLOWING THE IMPLANT IF THIS TRANSCATHETER BIOPROSTHETIC VALVE WITHIN A PRE-EXISTING NON-MEDTRONIC SURGICAL AORTIC VALVE, THE PATIENT PRESENTED TO THE HOSPITAL WITH CHEST PAIN. A TRANSESOPHAGEAL ECHOCARDIOGRAM REVEALED VALVE UNDER-EXPANSION, VALVE STENOSIS, AND A HIGH GRADIENT. THE PATIENT WAS HOSPITALIZED.

  Patient problems: Chest Pain; Transvalvular Pressure Gradient Increased

  MAUDE report 21874123 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO AN UNS PECIFIED ATRIO-VENTRICULAR BLOCK.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 21547438 ↗
• InjuryFeb 24, 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 FOR COMPLETE HEART BLOCK (CHB).

  Patient problems: Heart Block

  MAUDE report 21446899 ↗
• InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT FOLLOWING A PROCEDURE INVOLVING A TRANSCATHETER AORTIC VALVE REPLACEMENT, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO COMPLETE HEART BLOCK (CHB). ADDITIONAL INFORMATION WAS RECEIVED TO CLARIFY THE CHB OCCURRED DURING THE TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE.

  Patient problems: Heart Block

  MAUDE report 21196816 ↗
• MalfunctionJan 10, 2025Structural Problem; Structural Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, WHEN DELIVERING THE POST-BALLOON AORTIC VALVULOPLASTY (BAV), THE C-TAB OF THE VALVE WAS PUSHED BEHIND AND THROUGH THE ADJACENT CELL. PER THE PHYSICIAN, NO ADDITIONAL INTERVENTIONS WERE ATTEMPTED DUE TO THE RISK OUTWEIGHING THE BENEFIT. THE PATIENT'S AORTIC ROOT ANGLE CONTRIBUTED TO THE ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21129429 ↗
• MalfunctionJan 10, 2025Fracture; Device Markings/Labelling Problem; Fracture; Device Markings/Labelling Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, DURING LOADING WHEN THE LOADER WENT TO MARRY THE VALVE INSIDE OF THE COMPRESSION LOADING SYSTEM (CLS), THE VALVE WAS NOT CAPTURED ENOUGH AND FOLDED IN ON ITSELF. THE LOADER OPENED THE CLS AND WAS EXTREMELY ROUGH WHEN GETTING THE VALVE OUT, CAUSING THE STRUTS TO BREAK. ANOTHER VALVE WAS USED AND THE PROCEDURE WAS SUCCESSFUL. IT WAS ALSO REPORTED THAT AN ID CARD WAS SENT TO THE PATIENT WITH THE INCORRECT VALVE SN REGISTERED. THE REGISTRATION WAS CORRECTED AND A UPDATED ID CARD WAS MAILED TO THE PATIENT WITH A DATA CORRECTION LETTER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124283 ↗
• MalfunctionJan 9, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS CONSTRAINED AT 80% RELEASE. THE VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE REMOVED, AND A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED. THE VALVE AND DCS WERE REPLACED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21114127 ↗
• MalfunctionJan 8, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AT 80% DEPLOYMENT THE VALVE DID NOT APPEAR TO BE FULLY EXPANDED. THE VALVE WAS RECAPTURE AND REMOVED FROM THE PATIENT. A PRE-BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED AND A NEW VALVE WAS IMPLANTED SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21104420 ↗
• MalfunctionJan 8, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE ATTEMPTED IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WOULD NOT FULLY EXPAND. THE VALVE WAS WITHDRAWN FROM THE PATIENT AND DEPLOYED IN WARM SALINE, HOWEVER, THE VALVE CONTINUED TO NOT FULLY EXPAND. A DIFFERENT VALVE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102141 ↗
• MalfunctionDec 5, 2024Perivalvular Leak; Perivalvular Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT'S COMPUTED TOMOGRAPHY (CT) MEASUREMENTS WERE BORDERLINE FOR A 23 MILLIMETER (MM) AND 26MM VALVE. DUE TO A SMALLER LEFT VENTRICULAR OUTFLOW TRACT (LVOT), A 23MM VALVE WAS SELECTED. AT 80% DEPLOYMENT, MODERATE TO SEVERE PARAVALVULAR LEAK (PVL) WAS OBSERVED AS A RESULT OF THE SMALLER VALVE SIZE. THE VALVE WAS RECAPTURED, AND A 26MM VALVE WAS IMPLANTED. EXPANSION OF THE 26MM VALVE APPEARED APPROPRIATE UPON DEPLOYMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 20854325 ↗
• MalfunctionDec 4, 2024Perivalvular Leak; Inadequacy of Device Shape and/or Size; Perivalvular Leak; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT WAS SIZED FOR A 26 MILLIMETER (MM). HOWEVER, DUE TO LOW CORONARY ARTERIES, A 23MM VALVE WAS ATTEMPTED FOR THE IMPLANT. DURING THE ATTEMPTED IMPLANT, THE VALVE WAS DEPLOYED TO 80%. SEVERE PARAVALVULAR LEAK (PVL) WAS OBSERVED, AND THE VALVE WAS RECAPTURED AND REMOVED FROM THE PATIENT. A 26MM MEDTRONIC VALVE WAS IMPLANTED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 20846383 ↗
• DeathNov 27, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT IN THE HOSPITAL WITH CRITICAL HEART FAILURE AND ISCHEMIA UNDERWENT A PROCEDURE INVOLVING THE IMPLANTATION OF AN EVOLUTFX-23 VALVE. THE PATIENT PRESENTED WITH LOW BLOOD PRESSURE, RECORDED AT 80/45 MMHG AT THE START OF THE PROCEDURE. THE VALVE WAS ADVANCED TO THE ANNULUS AND DEPLOYED; HOWEVER, THE BLOOD PRESSURE DROPPED TO 40/20 MMHG. THE VALVE WAS DEPLOYED TO 80% AND PACING WAS STOPPED, BUT THE BLOOD PRESSURE DID NOT RECOVER. DESPITE THE USE OF ANESTHESIA FOR SEDATION AND ADMINISTRATION OF LIFESAVING MEDICATIONS, THE PATIENT'S CONDITION DID NOT IMPROVE. THE VALVE WAS RECAPTURED AND PULLED BACK INTO THE DESCENDING AORTA, AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. THE VALVE WAS THEN IMPLANTED. CPR AND MEDICATIONS CONTINUED. THE PATIENT'S RHYTHM CHANGED TO VENTRICULAR FLUTTER. SUBSEQUENTLY, DEFIBRILLATION WAS PERFORMED AND CPR CONTINUED. A DIAGNOSTIC CORONARY ANGIOGRAM SHOWED OPEN CORONARIES. AN ECHOCARDIOGRAM REVEALED NO PERFORATION OR REGURGITATION. THE PATIENT DID NOT CONVERT FROM VENTRICULAR FLUTTER AFTER MULTIPLE SHOCKS AND ADVANCED CARDIAC LIFE SUPPORT, AND THE PATIENT WAS PRONOUNCED DECEASED.

  Patient problems: Arrhythmia; Low Blood Pressure/ Hypotension

  MAUDE report 20798412 ↗

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-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-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-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