Evolut™ PRO+ EVPROPLUS-26USRecalls & reported problems

Summary

The FDA's MAUDE database contains 578 adverse event reports that list this exact device (DI 00763000211110), received between Oct 28, 2019 and Sep 23, 2026 — classified as 66 deaths, 458 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (184 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 578 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Insufficient Device Problem Information

  It was reported that approximately 6 years and 3 months following the implant of a transcatheter aortic valve, the valve failed due to an unspecified cause. No patient complications were reported as a result of this event.

  Patient problems: Insufficient Information

  MAUDE report 50871881 ↗
• InjuryAug 7, 2026Device Stenosis

  Additional information was received that a probable implant of a non-Medtronic transcatheter aortic bioprosthetic valve (TAV) was pl anned.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 50175405 ↗
• InjuryJul 31, 2026Gradient Increase; Patient Device Interaction Problem; Material Split, Cut or Torn; Intravalvular regurgitation

  It was reported that approximately 6 years and 2 months following the implant of a transcatheter aortic valve, the valve failed due to severe central aortic regurgitation and a thrombus on the valve leaflets. The patient suffered from shortness of breath and dyspnea as a result. Subsequently, the valve was explanted, and a surgical aortic valve was implanted.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea; Heart Failure/Congestive Heart Failure; Thrombosis/Thrombus

  MAUDE report 50103006 ↗
• InjuryJul 30, 2026Intravalvular regurgitation

  It was reported that 4 years and 10 months following implantation of a transcatheter aortic valve, moderate central regurgitation was identified. Subsequently, the patient was hospitalized.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50089989 ↗
• MalfunctionJun 24, 2026Gradient Increase; Perivalvular Leak; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE PATIENT EXPERIENCED SHORTNESS OF BREATH DUE TO STENOSIS AND MILD PARAVALVULAR LEAK. AN ECHOCARDIOGRAM REVEALED A MEAN GRADIENT OF 57.2 MMHG. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 25609208 ↗
• InjuryJun 3, 2026Gradient Increase; Incomplete Coaptation; Patient Device Interaction Problem; Material Split, Cut or Torn; Thickening of Material; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 3 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO AORTIC STENOSIS AND A MEAN GRADIENT OF 42 MILLIMETERS OF MERCURY (MMHG). THE PATIENT IS CURRENTLY BEING EVALUATED FOR POTENTIAL TREATMENT OPTIONS.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Heart Failure/Congestive Heart Failure; Thrombosis/Thrombus; Transvalvular Pressure Gradient Increased

  MAUDE report 25379347 ↗
• InjuryJun 3, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 3 YEARS AND 9 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO SEVERE CENTRAL AORTIC REGURGITATION. SUBSEQUENTLY, THE VALVE WAS EXPLANTED, AND A SURGICAL AORTIC VALVE WAS IMPLANTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 25376862 ↗
• MalfunctionJun 2, 2026Perivalvular Leak

  IT WAS REPORTED THAT 5 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE INTO A PREVIOUSLY IMPLANTED SURGICAL VALVE, PARAVALVULAR LEAK (PVL) OF UNKNOWN SEVERITY WAS IDENTIFIED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 25364713 ↗
• InjuryMay 28, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 5 YEARS AND 1 MONTH FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO SEVERE CENTRAL AORTIC REGURGITATION.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 25317076 ↗
• DeathMay 12, 2026Patient Device Interaction Problem; Intravalvular regurgitation; Unspecified Valve Regurgitation

  IT WAS REPORTED, APPROXIMATELY 6 YEARS AND 4 MONTHS FOLLOWING THE IMPLANT OF THIS 26 MM TRANSCATHETER AORTIC BIOPROSTHETIC VALVE (TAV), THE PATIENT WAS HOSPITALIZED FOR A ST-ELEVATION MYOCARDIAL INFARCT (STEMI). THE PATIENT WAS TAKEN TO THE CATHETERIZATION LABORATORY, WHICH CONFIRMED MODERATE AORTIC INSUFFICIENCY (AI) WITH NO PRESENCE OF A LESION. THE PATIENT DECOMPENSATED AND PASSED IN THE FOLLOWING DAYS. PER THE PHYSICIAN, THE CAUSE OF DEATH WAS ACUTE AI AND THE VALVE CONTRIBUTED TO THE DEATH.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Cardiac Arrest; Ischemic Heart Disease

  MAUDE report 25148408 ↗
• MalfunctionMay 8, 2026Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO STENOSIS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 25129036 ↗
• MalfunctionMay 8, 2026Gradient Increase; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED. A NON-MEDTRONIC GUIDEWIRE WAS USED DURING THE IMPLANT PROCEDURE. THE DEPLOYMENT STARTING POINT WAS AT THE TIP OF THE PIGTAIL CATHETER. FOLLOWING THE IMPLANT OF THE VALVE AT AN IMPLANT DEPTH OF 5 MILLIMETERS (MM) ON THE NATIVE ANNULUS, A POST-IMPLANT BAV WAS PERFORMED FOR AN UNKNOWN REASON. SUBSEQUENTLY, THE VALVE DISLODGED TO 0 MM. FOLLOWING VALVE DISLODGEMENT, A SECOND VALVE WAS INTENDED FOR A VALVE-IN-VALVE; HOWEVER, THE PHYSICIAN DECIDED NOT TO IMPLANT THE SECOND VALVE FOR AN UNSPECIFIED REASON. ADDITIONAL INFORMATION WAS RECEIVED THAT FOLLOWING THE POST-IMPLANT BAV, THE PATIENT'S TRANSVALVULAR PRESSURE GRADIENT SIGNIFICANTLY IMPROVED. BASED ON COMPREHENSIVE ASSESSMENT AS WELL AS THE INHERENT SURGICAL RISK ASSOCIATED WITH A VALVE-IN-VALVE IMPLANT, THE PHYSICIAN DECIDED TO NOT PROCEED WITH THE IMPLANT OF THE SECOND VALVE. ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT ANATOMICAL FACTORS, SPECIFICALLY ANNULAR CALCIFICATION, MAY HAVE LEAD TO AN ELEVATED TRANSVALVULAR PRESSURE GRADIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Transvalvular Pressure Gradient Increased

  MAUDE report 25124541 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

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

  Patient problems: Heart Block

  MAUDE report 25086773 ↗
• MalfunctionMay 5, 2026Calcified; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 5 YEARS AND 10 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO STENOSIS AND CALCIFICATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Stenosis; Calcium Deposits/Calcification

  MAUDE report 25082136 ↗
• InjuryApr 17, 2026Perivalvular Leak

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE FIRST VALVE WAS INADVERTENTLY DEPLOYED AT AN UNINTENDED DEPTH. FOLLOWING THE IMPLANT OF THE VASCULAR PLUG, MILD PVL REMAINED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24916749 ↗
• InjuryApr 17, 2026Perivalvular Leak; Malposition of Device

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, THE VALVE WAS IMPLANTED BUT WAS NOTED TO BE POSITIONED R ELATIVELY HIGH IN RELATION TO THE AORTIC ANNULUS. ADDITIONALLY, IT WAS NOTED THAT THERE WAS SIGNIFICANT PARAVALVULAR LEAK (PVL). IN RESPONSE, THE ATTENDING PHYSICIAN DECIDED TO IMPLANT A SECOND VALVE INTO THE PREVIOUSLY IMPLANTED VALVE. AFTER IMPLANTATION OF THE SECOND TRANSCATHETER VALVE, MODERATE PARAVALVULAR LEAK WAS STILL IDENTIFIED. SUBSEQUENTLY, IT WAS DECIDED TO IMPLANT A NON-MEDTRONIC VASCULAR PLUG TO COMBAT THE PARAVALVULAR LEAK. ADDITIONAL INFORMATION WAS RECEIVED THAT THE FIRST VALVE WAS INADVERTENTLY DEPLOYED AT AN UNINTENDED DEPTH. FOLLOWING THE IMPLANT OF THE VASCULAR PLUG, MILD PVL REMAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INTENDED IMPLANT DEPTH OF THE FIRST VALVE WAS 3 MILLIMETERS (MM). THE ACTUAL IMPLANT DEPTH OF THE FIRST VALVE WAS 0 MM.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24916728 ↗
• InjuryApr 11, 2026Fluid/Blood Leak; Patient Device Interaction Problem; Thickening of Material

  IT WAS REPORTED, APPROXIMATELY FOUR YEARS, EIGHT MONTHS AFTER THE IMPLANT OF THIS TRANSCATHETER AORTIC BIOPROSTHETIC VALVE (TAV), THE PATIENT WAS HOSPITALIZED DUE TO UNSPECIFIED AORTIC INSUFFICIENCY. TWO DAYS LATER, COMPUTED TOMOGRAPHY (CT) IMAGING WAS OBTAINED TO DETERMINE VIABLE TREATMENT OPTIONS. UPON SUBJECT MATTER EXPERT REVIEW OF THE CT IMAGES, THE LEAFLETS APPEARED THICKENED WITH THROMBUS/PANNUS FORMATION AND THE TAV FRAME RANGED 3.6¿4.3MM DEEP TO THE NATIVE ANNULUS. NO TREATMENT OR INTERVENTION WAS PERFORMED. NO OTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Thrombosis/Thrombus

  MAUDE report 24852599 ↗
• MalfunctionMar 30, 2026Patient Device Interaction Problem; Thickening of Material; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 4 YEARS AND 11 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO STENOSIS AND LEAFLET CALCIFICATION. THE PATIENT SUFFERED FROM HEART FAILURE AND HEMODYNAMIC INSTABILITY AS A RESULT.

  Patient problems: Aortic Valve Stenosis; Calcium Deposits/Calcification; Heart Failure/Congestive Heart Failure; Hemodynamic instability

  MAUDE report 24716863 ↗
• InjuryMar 25, 2026Calcified; Intravalvular regurgitation

  IT WAS REPORTED THAT 4 YEARS AND 4 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, CENTRAL REGURGITATION OF SEVERE SEVERITY WAS IDENTIFIED AS WELL AS CALCIFICATION OF THE TRANSCATHETER AORTIC VALVE. CENTRAL REGURGITATION OF THE PATIENT'S MITRAL VALVE WAS ADDITIONALLY IDENTIFIED. SUBSEQUENTLY, A TRANSCATHETER AORTIC VALVE WAS IMPLANTED VALVE-IN-VALVE TO REPLACE THE PREVIOUSLY IMPLANTED VALVE. PER THE PHYSICIAN, THE DEPTH OF IMPLANT CONTRIBUTED TO THE EVENT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Calcium Deposits/Calcification

  MAUDE report 24691696 ↗
• InjuryMar 6, 2026Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT 4 YEARS AND 3 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE WAS EXPLANTED AND A SURGICAL AORTIC VALVE WAS IMPLANTED.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 24533728 ↗
• DeathMar 4, 2026Difficult or Delayed Positioning; Perivalvular Leak; Device Dislodged or Dislocated; Insufficient Device Problem Information; 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. 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 IMPLANT PROCE

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

  MAUDE report 24514500 ↗
• InjuryMar 3, 2026Insufficient Device Problem Information; Intravalvular regurgitation; Unspecified Valve Regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 5 YEARS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC BIOPROSTHETIC VALVE (TAV), THE VALVE FAILED DUE TO AN UNSPECIFIED CAUSE. THE PATIENT IS CURRENTLY BEING EVALUATED FOR A TAV-IN-TAV PROCEDURE TO ADDRESS THE VALVE FAILURE. ADDITIONAL INFORMATION WAS RECEIVED THAT A TAV-IN-TAV HAS NOT BEEN SCHEDULED YET.

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

  MAUDE report 24497511 ↗
• InjuryMar 2, 2026Perivalvular Leak; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC BIOPROSTHETIC VALVE (TAV), UPON THE FIRST DEPLOYMENT ATTEMPT, CIRCULATORY COLLAPSE AND A DROP IN BLOOD PRESSURE WAS OBSERVED. SUBSEQUENTLY, THE VALVE WAS RECAPTURED TO ADJUST THE DEPLOYMENT DEPTH. THE VALVE WAS SUCCESSFULLY IMPLANTED ON THE SECOND ATTEMPT, HOWEVER THE PATIENT'S BLOOD PRESSURE DID NOT RECOVER. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS INITIATED. SUBSEQUENTLY, UPON IMAGE REVIEW IT WAS OBSERVED THAT THE VALVE HAD MIGRATED, WITH "SIGNIFICANT" PARAVALVULAR LEAK (PVL). A SECOND VALVE WAS IMPLANTED IN A DEEPER POSITION, AND A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 22 MILLIMETER (MM) BALLOON, WHICH PROVIDED SIGNIFICANT IMPROVEMENT TO THE PVL.

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

  MAUDE report 24484912 ↗
• MalfunctionMar 2, 2026Activation Failure

  IT WAS REPORTED THAT PRIOR TO THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED WITH A 20 MILLIMETER (MM) BALLOON. TWO INITIAL DEPLOYMENT ATTEMPTS WERE MADE, HOWEVER THE VALVE WOULD NOT FULLY EXPAND. THE SYSTEM WAS SUBSEQUENTLY WITHDRAWN FROM THE PATIENT. FOLLOWING WITHDRAWAL, IT WAS OBSERVED THAT THE DELIVERY CATHETER SYSTEM (DCS) HAD KINKED. A NEW VALVE AND DCS WERE OPENED, AN ADDITIONAL PRE-IMPLANT BAV WAS PERFORMED WITH A 22 MM BALLOON AND THE NEW VALVE WASSUCCESSFULLY IMPLANTED. PER THE PHYSICIAN, THE PATIENT'S SEVERELY CALCIFIED ANATOMY CONTRIBUTED TO THE EXPANSION ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE WAS RECAPTURED TWICE DUE TO BOTH FRAME UNDER EXPANSION AND POSITIONING DIFFICULTIES; HOWEVER, THE UNDER EXPANDED VALVE WAS IMPLANTED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484850 ↗
• InjuryFeb 27, 2026Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 5 YEARS AND 11 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO AORTIC STENOSIS. THE PATIENT SUFFERED A STROKE AS A RESULT, AND IS BEING EVALUATED FOR A POTENTIAL THROMBUS.

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

  MAUDE report 24472054 ↗

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