CoreValve™ Evolut™ PRO EVOLUTPRO-29-US (UDI 00763000017835)Recalls & reported problems

Summary

The FDA's MAUDE database contains 596 adverse event reports that list this exact device (DI 00763000017835), received between May 2, 2018 and Sep 29, 2026 — classified as 30 deaths, 493 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (117 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 596 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Patient Device Interaction Problem; Device Stenosis

  Patient problems: Aortic Valve Stenosis; Heart Failure/Congestive Heart Failure

  MAUDE report 50936820 ↗
• InjurySep 21, 2026Device Stenosis

  It was reported that approximately eight years and one month following the implant of an Evolut PRO transcatheter valve, stenosis was identified. It was noted that an intervention was required, and the patient was undergoing evaluation to determine a treatment plan for the valve stenosis.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 50839178 ↗
• MalfunctionAug 26, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50461346 ↗
• InjuryAug 5, 2026Intravalvular regurgitation; Unspecified Valve Regurgitation

  It was reported that approximately 7 years following the implant of a transcatheter aortic valve, the valve failed due to regurgitation of unspecified type and severity. It was noted that a valve-in-valve procedure will be required to treat the regurgitation.

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

  MAUDE report 50145564 ↗
• InjuryJul 27, 2026Patient Device Interaction Problem

  It was reported that during the attempted implant of a transcatheter aortic valve, upon deployment of the valve to 80%, ventricular fibrillation was observed, secondary to coronary vasospasms. Medication was administered, however the medication was unsuccessful. Subsequently, the patient was referred to surgery.

  Patient problems: Vasospasm; Ventricular Fibrillation

  MAUDE report 50011282 ↗
• InjuryJun 19, 2026Patient 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 25561115 ↗
• InjuryApr 20, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 7 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO SEVERE CENTRAL AORTIC REGURGITATION. THE PATIENT WAS HOSPITALIZED AS A RESULT. PER THE PHYSICIAN, A FLAIL LEAFLET CONTRIBUTED TO THE REGURGITATION. ADDITIONAL INFORMATION WAS RECEIVED THAT APPROXIMATELY 2 WEEKS AFTER THE VALVE FAILURE WAS IDENTIFIED, A NON-MEDTRONIC TRANSCATHETER VALVE WAS IMPLANTED AS TREATMENT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24931780 ↗
• InjuryApr 17, 2026Perivalvular Leak; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, AFTER IMPLANTATION OF THE VALVE, MILD PARAVALVULAR LEAK (PVL) WAS NOTED. SUBSEQUENTLY, A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS COMPLETED WITH A 23-MILLIMETER (MM) BALLOON. DURING THE POST-IMPLANT BAV, THE VALVE DISLODGED, WHICH RESULTED IN THE PATIENT HAVING SEVERE PVL. IN RESPONSE, THE ATTENDING PHYSICIAN DECIDED TO IMPLANT A SECOND VALVE INTO THE PREVIOUSLY IMPLANTED VALVE. AFTER IMPLANT OF THE SECOND TRANSCATHETER VALVE, THE PATIENT'S PVL IMPROVED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Foreign Body In Patient

  MAUDE report 24915695 ↗
• InjuryApr 16, 2026Insufficient Device Problem Information; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE FAILED DUE TO SEVERE CENTRAL AORTIC REGURGITATION. SUBSEQUENTLY, A 23 MILLIMETER (MM) NON-MEDTRONIC TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 24900076 ↗
• InjuryApr 13, 2026Gradient Increase; Insufficient Device Problem Information; Activation Failure; Patient Device Interaction Problem; Thickening of Material; Unspecified Valve Regurgitation

  IT WAS REPORTED THAT 6 YEARS AND 11 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, AN UNSPECIFIED VALVE FAILURE OCCURRED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Foreign Body Reaction; Insufficient Information; Thrombosis/Thrombus; Transvalvular Pressure Gradient Increased

  MAUDE report 24866975 ↗
• MalfunctionApr 9, 2026Material Invagination; Activation Failure

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, THE FIRST VALVE FAILED TO UNFOLD PROPERLY AND DID NOT MEET THE IMPLANTATION REQUIREMENTS. SUBSEQUENTLY, THE VALVE WAS RECAPTURED AND WITHDRAWN FROM THE PATIENT. A NEW VALVE WAS THEN PREPARED AND THE DELIVERY CATHETER SYSTEM (DCS) WAS INSERTED INTO THE PATIENT. WHILE ATTEMPTING TO IMPLANT THE SECOND VALVE, PERICARDIAL EFFUSION WAS NOTED. IN RESPONSE, THE VALVE AND DCS WERE WITHDRAWN FROM THE PATIENT. THE PATIENT WAS THEN PROVIDED SURGICAL TREATMENT FOR THE PERICARDIAL EFFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24831562 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, THE PATIENT'S CORONARY RISK WAS FOUND TO BE HIGHER THAN ANTICIPATED. IN CONSIDERATION OF THE PATIENT'S LOW EJECTION FRACTION AND POOR CARDIAC FUNCTION, IT WAS DECIDED TO ABORT THE TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE AND TRANSITION TO ADDRESSING THE CORONARY ARTERIES.

  Patient problems: Coronary obstruction/occlusion

  MAUDE report 24830665 ↗
• InjuryApr 8, 2026Perivalvular Leak

  IT WAS REPORTED THAT FOLLOWING THE SUCCESSFUL IMPLANT OF A TRANSCATHETER AORTIC VALVE, PARAVALVULAR LEAK (PVL) OF UNSPECIFIED SEVERITY WAS IDENTIFIED. GIVEN THE POSITIONING OF THE VALVE, IT WAS DETERMINED THAT THE VALVE WAS AT RISK FOR DISLODGE WITH A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV). SUBSEQUENTLY, IT WAS DECIDED TO IMPLANT A SECOND VALVE VALVE-IN-VALVE TO SEAL THE CALCIFIED AREA AND ENSURE STABILITY DURING THE POST-IMPLANT BAV. FOLLOWING THE IMPLANT OF THE SECOND VALVE AND THE BAV, IT WAS NOTED THAT THE PVL HAD IMPROVED, AND THE GRADIENT WAS 3 MILLIMETERS OF MERCURY (MMHG).

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 24816986 ↗
• MalfunctionApr 2, 2026Material Invagination; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE LOAD WAS CONFIRMED VISUALLY, TACTILELY, AND ON FLUOROSCOPY. THE VALVE WAS LOADED 3 TIMES BEFORE USE; HOWEVER, IT WAS REPORTED THAT A MISLOAD WAS NOT IDENTIFIED DURING LOADING. A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED USING A 20 MM NON-MEDTRONIC BALLOON. THE INFOLD IN THE VALVE WAS FIRST IDENTIFIED AFTER THE THIRD DEPLOYMENT ATTEMPT, AND THE VALVE WAS RECAPTURED 3 TIMES. PER THE PHYSICIAN, AORTIC CALCIFICATION CONTRIBUTED TO THE INFOLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24765621 ↗
• InjuryMar 30, 2026Perivalvular Leak; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Patient Device Interaction Problem

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF A 29 MILLIMETER (MM) TRANSCATHETER AORTIC VALVE, THE VALVE DISLODGED. SUBSEQUENTLY, THE VALVE WAS SNARED INTO THE SINOTUBULAR JUNCTION (STJ), AND A 34 MM VALVE WAS IMPLANTED VALVE-IN-VALVE. AN ADDITIONAL VALVE WAS IMPLANTED IN THE ASCENDING AORTIC ARCH IN ORDER TO SECURE THE 34 MM VALVE.

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

  MAUDE report 24714602 ↗
• InjuryMar 25, 2026Insufficient Device Problem Information; Patient Device Interaction Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT 6 YEARS AND 11 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, AN UNSPECIFIED VALVE FAILURE OCCURRED.

  Patient problems: Insufficient Information; Thrombosis/Thrombus

  MAUDE report 24688720 ↗
• InjuryMar 24, 2026Calcified; Patient Device Interaction Problem; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT CALCIFICATION WAS OBSERVED ON THE VALVE LEAFLETS.

  Patient problems: Aortic Valve Stenosis; Heart Failure/Congestive Heart Failure

  MAUDE report 24680574 ↗
• InjuryMar 19, 2026Perivalvular Leak; Device Dislodged or Dislocated; Activation Failure

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, POST-IMPLANT BALLOON DILATATION WAS PERFORMED. SUBSEQUENTLY, THE VALVE DISLODGED. A NEW VALVE WAS LOADED INTO A NEW DELIVERY CATHETER SYSTEM (DCS) AND SUCCESSFULLY IMPLANTED.

  Patient problems: Foreign Body In Patient; Valvular Insufficiency/ Regurgitation

  MAUDE report 24638028 ↗
• InjuryMar 16, 2026Fluid/Blood Leak; Perivalvular Leak

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER AORTIC BIOPROSTHETIC VALVE (TAV), MILD PARAVALVULAR LEAK WAS NOTED. APPROXIMATELY SIX YEARS, NINE AND A HALF MONTHS FOLLOWING VALVE IMPLANT, VALVE FAILURE WAS REPORTED. THE PRIMARY MODE OF VALVE FAILURE WAS STRUCTURAL VALVE DETERIORATION: PREDOMINANT AORTIC REGURGITATION WITHOUT HEMODYNAMIC VALVE DETERIORATION. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH RE-INTERVENTION FOR THE FAILED TAV. A SECOND NON-MEDTRONIC VALVE WAS IMPLANTED WITHIN THE MEDTRONIC TAV.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24606889 ↗
• InjuryMar 11, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 5 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569873 ↗
• InjuryMar 11, 2026Device Stenosis

  IT WAS REPORTED THAT 6 YEARS AND 6 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, VALVULAR STENOSIS WAS IDENTIFIED. SUBSEQUENTLY, A TRANSCATHETER AORTIC VALVE WAS IMPLANTED VALVE-IN-VALVE TO REPLACE THE VALVE.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 24568446 ↗
• MalfunctionMar 10, 2026Intravalvular regurgitation

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

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24562902 ↗
• MalfunctionMar 10, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 2 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 24562827 ↗
• InjuryMar 4, 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 AORTIC STENOSIS. THE PATIENT WAS RE-HOSPITALIZED AS A RESULT. THE PATIENT IS BEING EVALUATED FOR POTENTIAL TREATMENT OPTIONS.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 24507404 ↗
• InjuryMar 4, 2026Gradient Increase; Perivalvular Leak; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 5 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO A MEAN GRADIENT OF 44 MILLIMETERS OF MERCURY (MM HG). MILD CENTRAL AORTIC REGURGITATION AND TRACE PARAVALVULAR LEAK (PVL) WERE ALSO OBSERVED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE OUTCOMES AS A RESULT OF THE FAILED VALVE. APPROXIMATELY 2 MONTHS AFTER THE VALVE FAILURE WAS IDENTIFIED, A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WAS PERFORMED AS TREATMENT USING A NON-MEDTRONIC TRANSCATHETER AORTIC VALVE.

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

  MAUDE report 24507336 ↗

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