Evolut™ FX EVOLUTFX-26Recalls & reported problems

Summary

The FDA's MAUDE database contains 382 adverse event reports that list this exact device (DI 00763000370695), received between Jul 28, 2022 and Sep 22, 2026 — classified as 51 deaths, 276 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (154 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 382 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Insufficient Device Problem Information

  It was reported that approximately 3 years and 3 months following the implant of a transcatheter aortic valve, the valve was explanted for an unspecified reason. Subsequently, a surgical aortic valve was implanted.

  Patient problems: Insufficient Information

  MAUDE report 50856312 ↗
• MalfunctionSep 17, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50808792 ↗
• InjuryMay 19, 2026Perivalvular Leak; Patient Device Interaction Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT 8 MONTHS FOLLOWING IMPLANTATION OF A TRANSCATHETER AORTIC VALVE, IN A PATIENT WITH A PREVIOUSLY IMPLANTED SURGICAL VALVE, ENDOCARDITIS WITH STREPTOCOCCUS MITIS BACTERIUM WAS IDENTIFIED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). SUBSEQUENTLY, THE PATIENT WAS PUT ON CHRONIC SUPPRESSIVE ANTIBIOTIC THERAPY. 2 YEARS AND 5 MONTHS FOLLOWING IMPLANTATION OF THE TRANSCATHETER AORTIC VALVE, SEVERE CENTRAL REGURGITATION WAS IDENTIFIED, AS WELL AS MODERATE PARAVALVULAR LEAK (PVL). SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Endocarditis

  MAUDE report 25224535 ↗
• InjuryApr 10, 2026No Apparent Adverse Event; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON THE SAME DAY AS THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE WAS EXPLANTED FOR AN UNSPECIFIED CAUSE. ADDITIONAL INFORMATION WAS RECEIVED TO CLARIFY THAT THIS TRANSCATHETER VALVE WAS NOT TRULY IMPLANTED OR EXPLANTED. DURING THE ATTEMPTED IMPLANT OF THIS VALVE, THE DELIVERY CATHETER SYSTEM (DCS) WAS UNABLE TO ADVANCE DUE TO THE PATIENT'S SEVERE VESSEL CALCIFICATION. SUBSEQUENTLY, THE SYSTEM WAS WITHDRAWN FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839215 ↗
• InjuryApr 10, 2026No Apparent Adverse Event; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON THE SAME DAY AS THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE WAS EXPLANTED FOR AN UNSPECIFIED CAUSE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839144 ↗
• DeathMar 30, 2026Gradient Increase; Insufficient Device Problem Information; Patient Device Interaction Problem; Thickening of Material; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE MEAN GRADIENT WHEN THE PATIENT PRESENTED WITH HIGH GRADIENTS WAS 86 MILLIMETERS OF MERCURY (MM HG), AND THERE WAS EVIDENCE OF LEAFLET THICKENING ON THE TRANSCATHETER VALVE, BUT NO EVIDENCE OF THROMBUS ON THE TRANSCATHETER VALVE. PRIOR TO THE TAV-IN-TAV, THE PATIENT WAS IN CARDIOGENIC SHOCK FROM THE TRANSCATHETER VALVE. PER THE PHYSICIAN, THE CAUSE OF DEATH WAS UNKNOWN; HOWEVER, IT WAS NOTED THAT THE CAUSE OF DEATH WAS NOT CARDIAC. THE PATIENT'S UNDERLYING MEDICAL HISTORY CONTRIBUTED TO THE DEATH.

  Patient problems: Aortic Valve Stenosis; Cardiogenic Shock; Heart Failure/Congestive Heart Failure; Hemodynamic instability; Inflammation

  MAUDE report 24723066 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

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

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 24299152 ↗
• InjuryJan 16, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 2 YEARS AND 3 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE WAS EXPLANTED DUE TO AN UNSPECIFIED REASON. SUBSEQUENTLY, A BIOPROSTHETIC TISSUE VALVE WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24099968 ↗
• InjuryJan 16, 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 AN UNSPECIFIED ATRIO-VENTRICULAR (AV) BLOCK. ADDITIONAL INFORMATION WAS RECEIVED THAT ON THE SAME DAY AS THE IMPLANT OF THE VALVE, THE PATIENT DEVELOPED SECOND DEGREE AV BLOCK. THE NEXT MORNING, THE AV BLOCK PROGRESSED TO COMPLETE HEART BLOCK (CHB); THEREFORE, A PACEMAKER WAS IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED TO CLARIFY THAT THE SECOND DEGREE AV BLOCK FIRST OCCURRED POS-OPERATIVELY THE DAY FOLLOWING THE IMPLANT OF THE VALVE.

  Patient problems: Heart Block; Non specific EKG/ECG Changes

  MAUDE report 24094844 ↗
• InjuryJan 8, 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 24007512 ↗
• InjuryJan 2, 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) AND ATRIAL ARRYTHMIAS.

  Patient problems: Arrhythmia; Heart Block

  MAUDE report 23945103 ↗
• InjuryDec 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE COMPLETE HEART BLOCK (CHB) OCCURRED DURING THE VALVE IMPLANT PROCEDURE.

  Patient problems: Heart Block

  MAUDE report 23913819 ↗
• InjuryDec 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE CHB FIRST OCCURRED ON THE DAY OF THE VALVE IMPLANT PROCEDURE.

  Patient problems: Heart Block

  MAUDE report 23851968 ↗
• DeathNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE ATTEMPTED IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE DELIVERY CATHETER SYSTEM (DCS) WAS UNABLE TO BE ADVANCED OVER THE NON-MEDTRONIC GUIDEWIRE IN THE AREA OF THE ABDOMINAL AORTA. SUBSEQUENTLY, THE DCS AND VALVE WERE WITHDRAWN FROM THE PATIENT; HOWEVER, DIFFICULTY WAS ALSO EXPERIENCED DURING THE WITHDRAWAL OF THE DCS FOR THE SAME REASON. FOLLOWING WITHDRAWAL, A NEW VALVE WAS IMPLANTED IN THE PATIENT RESULTING IN A 30-MINUTE PROCEDURAL DELAY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED TO REPORT APPROXIMATELY ONE YEAR, THREE WEEKS FOLLOWING THE VALVE IMPLANT PROCEDURE, THE PATIENT DIED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23647426 ↗
• MalfunctionNov 21, 2025Fluid/Blood Leak; Perivalvular Leak; Fluid/Blood Leak; Perivalvular Leak

  IT WAS REPORTED THAT APPROXIMATELY 2 YEARS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE VALVE FAILED DUE TO AORTIC INSUFFICIENCY OF UNSPECIFIED SEVERITY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 23619366 ↗
• InjuryNov 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE VALVE IMPLANT PROCEDURE, A BUNDLE BRANCH BLOCK OCCURRED.

  Patient problems: Arrhythmia

  MAUDE report 23595528 ↗
• MalfunctionNov 4, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Thickening of Material; Insufficient Device Problem Information; Patient Device Interaction Problem; Thickening of Material

  IT WAS REPORTED THAT APPROXIMATELY 2 YEARS AND 7 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE VALVE FAILED DUE TO AN UNKNOWN REASON. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED THAT REVEALED LEAFLET THICKENING WITH THROMBUS/PANNUS FORMATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT APPROXIMATELY TWO YEARS AND SIX MONTHS FOLLOWING THE VALVE IMPLANT, EXAMINATION AND IMAGING SHOWED THE AORTIC VALVE WELL SEATED WITH NO PARAVALVULAR LEAK (PVL)OR ISSUES NOTED. ADDITIONAL INFORMATION WAS RECEIVED THAT NO TREATMENT WAS PRESCRIBED FOR THE TRANSCATHETER AORTIC VALVE AS IT WAS DEEMED NOT TO HAVE FAILED AND THE PATIENT WAS NOT TREATED FOR THROMBUS. THE PATIENT IS BEING EVALUATED FOR TRANSCATHETER MITRAL VALVE REPLACEMENT DUE TO SEVERE MITRAL REGURGITATION.

  Patient problems: Foreign Body Reaction; Mitral Valve Insufficiency/ Regurgitation; Thrombosis/Thrombus

  MAUDE report 23467486 ↗
• InjuryOct 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 1 DAY FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED FOR AN UNSPECIFIED ATRIO-VENTRICULAR (AV) BLOCK.

  Patient problems: Heart Block; Non specific EKG/ECG Changes

  MAUDE report 23428749 ↗
• InjuryOct 21, 2025Patient Device Interaction Problem; Patient 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 23347809 ↗
• InjurySep 10, 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 AN UNSPECIFIED ATRIO-VENTRICULAR (AV) BLOCK.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23016889 ↗
• InjuryAug 29, 2025Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT APPROXIMATELY 2 YEARS AND 11 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE VALVE FAILED DUE TO A SEVERE PARAVALVULAR LEAK (PVL). SUBSEQUENTLY, THE VALVE WAS EXPLANTED AND A SURGICAL VALVE WAS IMPLANTED.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 22924098 ↗
• InjuryAug 22, 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 1 DAY FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO COMPLETE HEART BLOCK (CHB).

  Patient problems: Heart Block

  MAUDE report 22878067 ↗
• InjuryAug 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 1 DAY FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO COMPLETE HEART BLOCK (CHB).

  Patient problems: Heart Block

  MAUDE report 22861148 ↗
• InjuryAug 18, 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 1 DAY FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO COMPLETE HEART BLOCK (CHB).

  Patient problems: Heart Block

  MAUDE report 22830181 ↗
• InjuryAug 11, 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 ON THE SAME DAY AS A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO ATRIAL ARRYTHMIAS AND COMPLETE HEART BLOCK (CHB).

  Patient problems: Arrhythmia; Heart Block

  MAUDE report 22779431 ↗

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-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-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