CoreValve™ Evolut™ PRO EVOLUTPRO-26-US (UDI 00763000017828)Recalls & reported problems

Summary

The FDA's MAUDE database contains 305 adverse event reports that list this exact device (DI 00763000017828), received between May 14, 2018 and Sep 28, 2026 — classified as 26 deaths, 241 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (105 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 305 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50923972 ↗
• MalfunctionSep 23, 2026Gradient Increase; Device Stenosis; Unspecified Valve Regurgitation

  It was reported that approximately 7 years and 11 months following the implant of a transcatheter aortic valve, the valve failed due to aortic stenosis and a mean pressure gradient of 53 millimeters of mercury (mmHg). No patient complications were reported as a result of this event.

  Patient problems: Aortic Valve Stenosis; Transvalvular Pressure Gradient Increased; Valvular Insufficiency/ Regurgitation

  MAUDE report 50873660 ↗
• InjurySep 21, 2026Gradient Increase; Patient Device Interaction Problem; Intravalvular regurgitation

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

  MAUDE report 50847547 ↗
• MalfunctionSep 18, 2026Intravalvular regurgitation

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50826031 ↗
• InjuryAug 30, 2026Perivalvular Leak; Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Heart Failure/Congestive Heart Failure; Insufficient Information; Valvular Insufficiency/ Regurgitation

  MAUDE report 50512954 ↗
• InjuryJun 25, 2026Patient Device Interaction Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO SEVERE CENTRAL AORTIC REGURGITATION. THE PATIENT SUFFERED FROM HEART FAILURE AND HEMODYNAMIC INSTABILITY AS A RESULT. SUBSEQUENTLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL, AND IS PLANNED FOR A VALVE-IN-VALVE WITH A NON-MEDTRONIC VALVE.

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

  MAUDE report 25620181 ↗
• InjuryJun 18, 2026Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 6 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO STENOSIS. APPROXIMATELY 1 MONTH LATER, A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 25546259 ↗
• InjuryJun 10, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT ONE DAY FOLLOWING THE IMPLANTATION OF A TRANSCATHETER AORTIC VALVE, ATRIO-VENTRICULAR (AV) BLOCK OF UNSPECIFIED DEGREE OCCURRED AND A PERMANENT PACEMAKER WAS IMPLANTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 25462090 ↗
• MalfunctionMay 28, 2026Inadequacy of Device Shape and/or Size; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NOTHING IN TERMS OF PATIENT ANATOMY THAT CONTRIBUTED TO THE EXPANSION ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25317068 ↗
• InjuryMay 27, 2026Calcified

  IT WAS REPORTED THAT APPROXIMATELY 5 YEARS AND 8 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE PATIENT WAS RE-HOSPITALIZED DUE TO VALVE CALCIFICATION. SUBSEQUENTLY, THE VALVE WAS EXPLANTED, AND A SURGICAL AORTIC VALVE WAS IMPLANTED.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 25302801 ↗
• InjuryMay 19, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT 5 YEARS AND 10 MONTHS FOLLOWING IMPLANTATION OF A TRANSCATHETER AORTIC VALVE, THE VALVE WAS EXPLANTED FOR AN UNSPECIFIED REASON.

  Patient problems: Insufficient Information

  MAUDE report 25222587 ↗
• InjuryMay 5, 2026Perivalvular Leak; Patient Device Interaction Problem; Unspecified Valve Regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 10 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO MODERATE-SEVERE AORTIC INSUFFICIENCY.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 25082825 ↗
• MalfunctionMay 5, 2026Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 6 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO AN UNSPECIFIED REASON. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 25081904 ↗
• MalfunctionMay 4, 2026Perivalvular Leak; Device Stenosis

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER AORTIC BIOPROSTHETIC VALVE (TAV), MILD PARAVALVULAR LEAK WAS NOTED. APPROXIMATELY 6 YEARS, 10 MONTHS FOLLOWING VALVE IMPLANT, VALVE FAILURE WAS REPORTED. THE PRIMARY MODE OF VALVE FAILURE WAS STRUCTURAL VALVE DETERIORATION: PREDOMINANT AORTIC STENOSIS WITHOUT HEMODYNAMIC VALVE DETERIORATION. THE PATIENT WAS ENROLLED IN A CLINICAL STUDY WITH EXISTING, BASELINE VALVE FAILURE TO DETERMINE WHETHER A REDO-TAV REPLACEMENT PROCEDURE WAS APPROPRIATE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 25075929 ↗
• MalfunctionApr 13, 2026Patient Device Interaction Problem; Device Stenosis

  IT WAS REPORTED THAT 6 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, VALVE STENOSIS WAS IDENTIFIED.

  Patient problems: Aortic Valve Stenosis; Thrombosis/Thrombus

  MAUDE report 24867129 ↗
• DeathApr 13, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT FOLLOWING THE SUCCESSFUL IMPLANT OF A TRANSCATHETER AORTIC VALVE, A CORONARY OCCLUSION OCCURRED. IT WAS ATTEMPTED TO RESTORE CORONARY FLOW, HOWEVER IT WAS UNSUCCESSFUL, RESULTING IN CARDIAC ARREST. EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS INITIATED, HOWEVER DUE TO THE PROLONGED DURATION OF RESUSCITATION, IT WAS ASSESSED THAT OPEN CHEST INTERVENTION WOULD HAVE LIMITED BENEFIT, AND THE PATIENT ULTIMATELY DIED. ADDITIONAL INFORMATION WAS RECEIVED THAT PER THE PHYSICIAN, THE VALVE AND DELIVERY CATHETER SYSTEM (DCS) DID NOT CAUSE OR CONTRIBUTE TO THE CORONARY OCCLUSION. ADDITIONAL INFORMATION WAS RECEIVED THAT THE TRANSCATHETER VALVE DID NOT DISLODGE AND OCCLUDE THE CORONARY OSTIA, AND THE DCS DID NOT DISLODGE CALCIUM/PLAQUE THAT OCCLUDED THE CORONARY ARTERY. PER THE PHYSICIAN, THE CAUSE OF DEATH WAS DUE TO VALVE LEAFLET OBSTRUCTION OF THE CORONARY ARTERY; HOWEVER, THE TRANSCATHETER VALVE AND DCS CAN BE EXCLUDED AS CONTRIBUTING FACTORS TO THE DEATH.

  Patient problems: Cardiac Arrest; Coronary obstruction/occlusion

  MAUDE report 24862453 ↗
• MalfunctionApr 10, 2026Device Stenosis

  IT WAS REPORTED THAT 6 YEARS AND 9 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, VALVE STENOSIS WAS IDENTIFIED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 24845606 ↗
• DeathMar 30, 2026Gradient Increase; Perivalvular Leak; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT APPROXIMATELY 6 YEARS AND 5 MONTHS FOLLOWING THE IMPLANT OF THIS TAV, THE PATIENT BECAME SYMPTOMATIC WITH MULTIFACTORIAL DYSPNEA, LOWER EXTREMITY SWELLING, AND ORTHOPNEA. APPROXIMATELY 5 MONTHS LATER, THE PATIENT WAS HOSPITALIZED. APPROXIMATELY ONE MONTH FOLLOWING ADMISSION, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. HOWEVER, THREE DAYS FOLLOWING DISCHARGE, THE PATIENT WAS RE-ADMITTED AND TRANSFERRED TO A DIFFERENT HOSPITAL FOR A SECOND SURGICAL OPINION. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED THAT REVEALED THE SEVERE STENOSIS WITH A MEAN GRADIENT OF 56 MILLIMETERS OF MERCURY (MM HG), SEVERE CENTRAL AORTIC REGURGITATION, AS WELL AS SEVERE PARAVALVULAR LEAK (PVL), AND THE PATIENT WAS DENIED STRUCTURAL AND SURGICAL INTERVENTION. APPROXIMATELY 3 WEEKS AFTER RE-ADMISSION, THE PATIENT WAS DISCHARGED HOME WITH HOSPICE CARE. THREE DAYS LATER, THE PATIENT DIED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Dyspnea; Swelling/ Edema; Transvalvular Pressure Gradient Increased

  MAUDE report 24723569 ↗
• MalfunctionMar 25, 2026Device Stenosis

  IT WAS REPORTED THAT 6 YEARS AND 7 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, VALVE STENOSIS WAS IDENTIFIED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 24690800 ↗
• MalfunctionMar 24, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 8 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO AN UNSPECIFIED CAUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24676135 ↗
• InjuryMar 24, 2026Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT TREATMENT FOR THE VALVE WAS PLANNED. THE INTENTION WAS TO USE A NON-MEDTRONIC TRANSCATHETER VALVE AND PERFORM BI-LATERAL LEAFLET MODIFICATION.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24674948 ↗
• InjuryMar 15, 2026Patient Device Interaction Problem; Thickening of Material; Device Stenosis

  IT WAS REPORTED THAT 6 YEARS AND 8 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, POTENTIAL HYPERATTENUATED LEAFLET THICKENING (HALT) AND THROMBUS WERE IDENTIFIED. ADDITIONAL INFORMATION WAS RECEIVED THAT 6 YEARS AND 9 MONTHS FOLLOWING THE IMPLANT OF THE VALVE, THE TRANSCATHETER VALVE FAILED AND VALVULAR STENOSIS WAS OBSERVED. SUBSEQUENTLY, THE VALVE REQUIRED RE-INTERVENTION.

  Patient problems: Aortic Valve Stenosis; Thrombosis/Thrombus

  MAUDE report 24601779 ↗
• MalfunctionMar 12, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO CENTRAL AORTIC REGURGITATION OF UNSPECIFIED SEVERITY.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24580833 ↗
• InjuryMar 9, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT 6 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, CENTRAL REGURGITATION OF MODERATE SEVERITY WAS IDENTIFIED. SUBSEQUENTLY, THE TRANSCATHETER VALVE WAS EXPLANTED AND A SURGICAL AORTIC VALVE WAS IMPLANTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24546406 ↗
• DeathFeb 27, 2026Difficult or Delayed Positioning; Perivalvular Leak; Device Dislodged or Dislocated; Insufficient Device Problem Information; Activation Failure; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS COM PLETED. THE DELIVERY CATHETER SYSTEM (DCS) WAS THEN INSERTED INTO THE PATIENT AND PARTIALLY DEPLOYED. AS THE VALVE WAS PARTIALLY DEPLOYED, THE PATIENT EXPERIENCED HYPOTENSION AND CIRCULATORY COLLAPSE OCCURRED. THE VALVE WAS THEN RECAPTURED SO THAT THE PHYSICIAN COULD ADJUST THE DEPTH OF THE VALVE. THE VALVE WAS THEN REDEPLOYED AND FULLY IMPLANTED. AFTER FULL IMPLANTATION, THE PATIENT'S BLOOD PRESSURE DID NOT INCREASE. SUBSEQUENTLY, CHEST COMPRESSIONS WERE INITIATED, AND THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). IT WAS THEN IDENTIFIED VIA DIGITAL SUBTRACTION ANGIOGRAPHY (DSA), THAT THE VALVE HAD DISLODGED AND IN RESULT THERE WAS PARAVALVULAR LEAK (PVL). IT WAS THEN DECIDED TO IMPLANT A SECOND TRANSCATHETER AORTIC VALVE IN THE PREVIOUSLY IMPLANTED VALVE. AFTER IMPLANTATION OF THE SECOND VALVE, A POST-IMPLANT BAV WAS COMPLETED WITH A 22-MILLIMETER (MM) BALLOON, WHICH SIGNIFICANTLY IMPROVED THE PVL. THE PATIENT WAS PUT UNDER OBSERVATION. ADDITIONAL INFORMATION WAS RECEIVED THAT A NON-MEDTRONIC GUIDEWIRE WAS USED DURING THE IMPL

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Foreign Body In Patient; Hemodynamic instability; Insufficient Information; Low Blood Pressure/ Hypotension

  MAUDE report 24476689 ↗

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-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-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