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Evolut™ PRO+ EVPROPLUS-23USRecalls & reported problems

Medtronic Corevalve LLC · VLV EVPROPLUS-23 COMM US · Class 3 · Implant

All models of Medtronic Evolut TAVR (45) · Evolut PRO+ (8)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Medtronic Evolut PRO+ is an aortic heart valve placed through a catheter. Many of the 135 reports describe the valve dislodging or moving out of place, leaks around the valve, and some describe the valve failing years after implantation. The reports include 17 deaths and 101 injuries. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
134
Deaths reported
17
Injuries reported
101
Recalls naming it
0

Summary

The FDA's MAUDE database contains 134 adverse event reports that list this exact device (DI 00763000211103), received between Jan 9, 2020 and Jul 9, 2026 — classified as 17 deaths, 101 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (44 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.

Reports received per month

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 3 reportsFeb 2024: 3 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 1 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 2 reportsApr 2025: 6 reportsMay 2025: 3 reportsJun 2025: 3 reportsJul 2025: 1 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 2 reportsNov 2025: 2 reportsDec 2025: 3 reportsJan 2026: 2 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 2 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 1 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520266
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device Dislodged or Dislocated44
  • Adverse Event Without Identified Device or Use Problem36
  • Patient Device Interaction Problem24
  • Gradient Increase22
  • Perivalvular Leak22
  • Insufficient Device Problem Information16
  • Device Stenosis13
  • Activation Failure11

Patient problems

  • No Clinical Signs, Symptoms or Conditions40
  • Valvular Insufficiency/ Regurgitation19
  • Non specific EKG/ECG Changes15
  • Insufficient Information14
  • Heart Block11
  • Thrombosis/Thrombus10
  • Obstruction/Occlusion8
  • Aortic Valve Insufficiency/ Regurgitation7

Recent adverse event reports

The 25 most recent of 134 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 9, 2026Unspecified Valve Regurgitation

    Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

    MAUDE report 25762019 ↗
  • InjuryMay 26, 2026Calcified

    IT WAS REPORTED THAT APPROXIMATELY 3 YEARS AND 6 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 25283870 ↗
  • MalfunctionApr 14, 2026Device Stenosis

    IT WAS REPORTED THAT APPROXIMATELY 5 YEARS AND 5 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO AORTIC STENOSIS.

    Patient problems: Aortic Valve Stenosis

    MAUDE report 24877267 ↗
  • InjuryApr 13, 2026Patient Device Interaction Problem; Intravalvular regurgitation; Unspecified Valve Regurgitation

    IT WAS REPORTED THAT APPROXIMATELY 5 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO SEVERE AORTIC REGURGITATION. THE PATIENT SUFFERED HEMODYNAMIC INSTABILITY, AND WAS HOSPITALIZED AS A RESULT. THE PATIENT IS SCHEDULED FOR A VALVE-IN-VALVE PROCEDURE WITH A NON-MEDTRONIC 20 MILLIMETER (MM) VALVE APPROXIMATELY 3 DAYS FOLLOWING THE ONSET OF THE REGURGITATION.

    Patient problems: Hemodynamic instability; Valvular Insufficiency/ Regurgitation

    MAUDE report 24861755 ↗
  • MalfunctionMar 20, 2026Device Dislodged or Dislocated

    ADDITIONAL INFORMATION WAS RECEIVED THAT A PRE-IMPLANT BALLOON DILATION WAS PERFORMED. IT WAS NOTED THAT THE VALVE "OUT OF SYNC" MEANT THE VALVE DEPLOYMENT DID NOT RESPOND IN A ONE-TO-ONE MANNER WITH THE DELIVERY CATHETER SYSTEM (DCS) OPERATION. THE VALVE DISLODGED AFTER IT WAS FULLY RELEASED FROM THE DCS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24650143 ↗
  • InjuryJan 23, 2026Gradient Increase; Insufficient Device Problem Information; Device Stenosis

    IT WAS REPORTED THAT 4 YEARS AND 4 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, AN UNSPECIFIED VALVE FAILURE OCCURRED. ADDITIONAL INFORMATION WAS RECEIVED THAT AN ECHOCARDIOGRAM WAS PERFORMED APPROXIMATELY FOUR YEARS AND THREE MONTHS FOLLOWING THE VALVE IMPLANT WHICH SHOWED A WELL-SEATED TRANSCATHETER AORTIC BIOPROSTHETIC VALVE WITH SEVERE AORTIC STENOSIS WITH AN 80 MMHG PEAK GRADIENT AND 51 MMHG MEAN GRADIENT, AND AORTIC VALVE AREA (AVA) OF 0.5 CM2. THE MECHANISM FOR VALVE FAILURE WAS STENOSIS AND THE PATIENT WAS EXPERIENCING SYMPTOMS OF LIGHT-HEADEDNESS. IT WAS PLANNED TO IMPLANT ANOTHER VALVE BUT THE TYPE AND TIMING WAS NOT KNOWN.

    Patient problems: Dizziness; Insufficient Information

    MAUDE report 24164016 ↗
  • InjuryJan 21, 2026Calcified; Gradient Increase; Thickening of Material; Device Stenosis

    IT WAS REPORTED THAT APPROXIMATELY THREE YEARS, NINE AND A HALF MONTHS FOLLOWING THE IMPLANT OF A MEDTRONIC TRANSCATHETER AORTIC BIOPROSTHETIC VALVE (TAV), A MULTI-DETECTOR COMPUTED TOMOGRAPHY WAS PERFORMED. STRUCTURAL VALVE DETERIORATION WAS REPORTED; PREDOMINANT AORTIC STENOSIS WAS THE PRIMARY MODE OF VALVE FAILURE. THIS WAS CHARACTERIZED BY AN INCREASE IN MEAN GRADIENT OF >=20 MMHG FROM BASELINE AND A MEAN GRADIENT OF >=30 MMHG. THE PATIENT WAS ENROLLED IN A CLINICAL STUDY WITH EXISTING, BASELINE VALVE FAILURE TO DETERMINE WHETHER A REDO-TAV REPLACEMENT PROCEDURE, TAV-IN-TAV, WAS APPROPRIATE. APPROXIMATELY TWO AND A HALF MONTHS LATER, REINTERVENTION WAS PERFORMED. A NON-MEDTRONIC VALVE WAS IMPLANTED TAV-IN-TAV.

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

    MAUDE report 24133643 ↗
  • InjuryDec 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED BY THE PATIENT THAT APPROXIMATELY 2 YEARS AND 11 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED DUE TO AN UNKNOWN REASON. SUBSEQUENTLY, A NON-MEDTRONIC CARDIAC RHYTHM AND HEART FAILURE (CRHF) DEVICE WAS IMPLANTED.

    Patient problems: Insufficient Information

    MAUDE report 23897669 ↗
  • DeathDec 15, 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 1 YEAR AND 2 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, ENDOCARDITIS WAS CONFIRMED AND THE ORGANISM CULTURED WAS STREPTOCOCCI. IT WAS NOTED THAT THE PATIENT HAD ACTIVE PNEUMONIA WHICH COULD HAVE PREDISPOSED THE PATIENT TO ENDOCARDITIS. ADDITIONALLY, VEGETATION WAS NOT PRESENT ON ECHOCARDIOGRAM. THE PATIENT IS CURRENTLY PRESCRIBED SUPPRESSIVE ANTIBIOTICS. PER THE PHYSICIAN, THE VALVE AND IMPLANT PROCEDURE DID NOT CAUSE OR CONTRIBUTE TO THE INFECTION. APPROXIMATELY 4 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF THE VALVE, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED THAT REVEALED THE VALVE FAILED DUE TO AN UNKNOWN REASON AND THE PATIENT WAS HOSPITALIZED. ADDITIONALLY, POSSIBLE THROMBUS/PANNUS WAS OBSERVED INSIDE THE VALVE FRAME. ADDITIONAL INFORMATION WAS RECEIVED THAT THE TRANSCATHETER VALVE WAS IMPLANTED INTO THE NATIVE ANNULUS AT A FINAL DEPTH OF 4.9 MM ON THE LEFT CORONARY CUSP (LCC). THE VALVE FAILURE WAS DUE TO ENDOCARDITIS LEADING TO LEAFLET THICKENING. THROMBUS/PANNUS WAS CONFIRMED WITH THROMBUS NOTED ON THE VALVE LEAFLETS. THE PATIENT DIED BEFORE RECEIVING TREATMENT TO ADDRESS THE FAILED VALVE. THE PATIENT HAD A HISTORY OF ENDOC

    Patient problems: Endocarditis; Foreign Body Reaction; Heart Failure/Congestive Heart Failure; Pneumonia; Thrombosis/Thrombus

    MAUDE report 23810987 ↗
  • InjuryDec 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

    IT WAS REPORTED THAT 4 DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED FOR AN UNSPECIFIED ATRIO-VENTRICULAR (AV) BLOCK.

    Patient problems: Non specific EKG/ECG Changes

    MAUDE report 23758093 ↗
  • InjuryNov 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT APPROXIMATELY 4 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED FOR AN UNKNOWN REASON. SUBSEQUENTLY, A SURGICAL TISSUE VALVE WAS IMPLANTED.

    Patient problems: Insufficient Information

    MAUDE report 23658645 ↗
  • InjuryNov 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

    IT WAS REPORTED THAT 2 DAYS 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 23606937 ↗
  • InjuryOct 23, 2025Patient Device Interaction Problem; Intravalvular regurgitation; Patient Device Interaction Problem; Intravalvular regurgitation

    ADDITIONAL INFORMATION WAS RECEIVED THAT A NON-MEDTRONIC VALVE WAS IMPLANTED VALVE-IN-VALVE.

    Patient problems: Hemodynamic instability; Valvular Insufficiency/ Regurgitation

    MAUDE report 23367636 ↗
  • InjuryOct 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

    IT WAS REPORTED THAT ON THE DAY OF IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED FOR COMPLETE HEART BLOCK (CHB).

    Patient problems: Heart Block

    MAUDE report 23289384 ↗
  • DeathAug 20, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

    IT WAS REPORTED THAT APPROXIMATELY 4 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED WHICH REVEALED THE VALVE FAILED DUE TO AN UNKNOWN REASON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: Cancer; No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

    MAUDE report 22851326 ↗
  • InjuryJul 15, 2025Gradient Increase; Device Stenosis; Gradient Increase; Device Stenosis

    IT WAS REPORTED THAT APPROXIMATELY 4 YEARS AND 7 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE IN A PREVIOUSLY IMPLANTED NON-MEDTRONIC SURGICAL AORTIC VALVE, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED THAT REVEALED THE VALVE FAILED DUE TO STENOSIS. A MEAN GRADIENT OF 39 MILLIMETERS OF MERCURY (MM HG) WAS OBSERVED AS WELL. IT WAS PLANNED TO PERFORM A TRANSCATHETER AORTIC VALVE-IN-TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE USING A NON-MEDTRONIC TRANSCATHETER VALVE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22511288 ↗
  • MalfunctionJun 26, 2025Gradient Increase; Device Stenosis; Gradient Increase; Device Stenosis

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE INTO A PREVIOUSLY IMPLANTED NON-MEDTRONIC SURGICAL VALVE, FLUOROSCOPY AND TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWED GOOD POSITIONING AT 80% DEPLOYED. UPON FULL RELEASE OF THE VALVE, THE VALVE DISLODGED TO THE ASCENDING AORTA. THE IMPLANTING TEAM BELIEVED THERE WAS BACK TENSION ON THE DELIVERY CATHETER SYSTEM (DCS) THAT SNAGGED THE VALVE ALTHOUGH FORWARD PRESSURE WAS APPLIED UPON THE VALVE RELEASE. A SNARE WAS USED ON A PADDLE OF THE FIRST VALVE AND A SECOND VALVE WAS IMPLANTED SUCCESSFULLY. POST VALVE IMPLANT ANGIOGRAM CONFIRMED CORONARY PERFUSION AND GREATER HEAD VESSELS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.  ADDITIONAL INFORMATION WAS RECEIVED THAT APPROXIMATELY 4 YEARS FOLLOWING THE INITIAL VALVE IMPLANT PROCEDURE, THE CARDIOLOGIST NOTED A SYSTOLIC MURMUR. AN ECHOCARDIOGRAM WAS PERFORMED THAT REVEALED THE VALVE APPEARED WELL SEATED. THE GRADIENT AT THE TIME WAS BORDERLINE WITH A PEAK VELOCITY OF 2.4 M/S. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS LATER PERFORMED WHICH REVEALED FLOW ACCELERATION BETWEEN THE 2 TRANSCATHETER VALVES AND AN ELEVATED GRADIENT OF 15-17 MILLI

    Patient problems: No Clinical Signs, Symptoms or Conditions; Stenosis

    MAUDE report 22337698 ↗
  • InjuryJun 9, 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 PROCEDURE (TAVR), A PERMANENT PACEMAKER WAS IMPLANTED DUE TO AN UNSPECIFIED ATRIOVENTRICULAR (AV) BLOCK.

    Patient problems: Non specific EKG/ECG Changes

    MAUDE report 22170605 ↗
  • MalfunctionJun 3, 2025Patient Device Interaction Problem; Thickening of Material; Patient Device Interaction Problem; Thickening of Material

    IT WAS REPORTED THAT APPROXIMATELY 2 YEARS AND 9 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE IN A PREVIOUSLY IMPLANTED 23 MILLIMETER (MM) SURGICAL AORTIC VALVE, THE PATIENT PRESENTED FOR ROUTINE FOLLOW-UP OF CLASS I HEART FAILURE SYMPTOMS. HOWEVER, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED THAT REVEALED THE TRANSCATHETER VALVE HAD FAILED DUE TO EITHER HYPOATTENUATED LEAFLET THICKENING (HALT) OR HYPOATTENUATION AFFECTING MOTION (HAM).

    Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

    MAUDE report 22133594 ↗
  • InjuryMay 27, 2025Patient Device Interaction Problem; Thickening of Material; Device Stenosis; Intravalvular regurgitation; Patient Device Interaction Problem; Thickening of Material; Device Stenosis; Intravalvular regurgitation

    ADDITIONAL INFORMATION WAS RECEIVED THAT A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED REVEALING THE VALVE WAS WELL SEATED, AND ALL 3 LEAFLETS WERE MOVING WITHOUT RESTRICTION. THERE WAS MODERATE CENTRAL AORTIC REGURGITATION WITH AN ECCENTRIC JET. THE PATIENT WAS BEING WORKED UP FOR A VALVE-IN-VALVE PROCEDURE.

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

    MAUDE report 22088494 ↗
  • MalfunctionMay 7, 2025Device Stenosis; Device Stenosis

    IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE IN A PREVIOUSLY IMPLANTED 23 MILLIMETER (MM) TRANSCATHETER AORTIC VALVE, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED THAT REVEALED THE VALVE HAD FAILED DUE TO AORTIC STENOSIS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21978345 ↗
  • InjuryMay 7, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

    IT WAS REPORTED THAT APPROXIMATELY 2 YEARS AND 6 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED FOR AN UNSPECIFIED REASON. SUBSEQUENTLY, A SURGICAL AORTIC VALVE WAS IMPLANTED IN THE PATIENT.

    Patient problems: Embolism/Embolus; Ischemia Stroke; No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

    MAUDE report 21977630 ↗
  • MalfunctionApr 29, 2025Activation Failure; Activation Failure

    MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS PARTIALLY DEPLOYED BUT APPEARED CONSTRAINED. THE SYSTEM WAS REMOVED AND A NEW VALVE WAS USED FOR IMPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21928065 ↗
  • InjuryApr 28, 2025Gradient Increase; Patient Device Interaction Problem; Thickening of Material; Device Stenosis; Intravalvular regurgitation; Gradient Increase; Patient Device Interaction Problem; Thickening of Material; Device Stenosis; Intravalvular regurgitation

    IT WAS REPORTED THAT APPROXIMATELY 2 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE IN THE PATIENT'S NATIVE ANNULUS, AN ECHOCARDIOGRAM WAS PERFORMED THAT REVEALED MODERATE TO SEVERE AORTIC VALVE STENOSIS, AND A MEAN GRADIENT OF 33 MILLIMETERS OF MERCURY (MM HG) WITH A VALVE AREA OF 0.7 SQUARE CENTIMETERS. IT WAS NOTED THAT THE IMPLANT DEPTH AT THE NON-CORONARY CUSP (NCC) WAS 8 MILLIMETERS (MM), AND THE IMPLANT DEPTH AT THE LEFT CORONARY CUSP (LCC) WAS 8 MM. APPROXIMATELY 1 YEAR FOLLOWING THE IMPLANT OF THE TRANSCATHETER VALVE, THE PATIENT PRESENTED WITH WEAKNESS AND DYSPNEA. IT WAS REPORTED THAT THE PATIENT HAD ELEVATED TROPONIN LEVELS AND ELEVATED N-TERMINAL PRO-B-TYPE NATRIURETIC PEPTIDE (NT-PROBNP) LEVELS. SUBSEQUENTLY, A COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) SCAN WAS PERFORMED THAT SHOWED BILATERAL PULMONARY EMBOLI INVOLVING THE RIGHT SEGMENTAL AND SUBSEGMENTAL BRANCHES, AS WELL AS IN THE DISTAL LEFT MAIN PULMONARY ARTERY EXTENDING INTO THE SEGMENTAL LEFT UPPER LOBE BRANCHES. ADDITIONALLY, SIGNIFICANT PERIPHERAL HYPOATTENUATED LEAFLET THICKENING (HALT) ON THE VALVE LEAFLETS AND REDUCED SYSTOLIC EXCURSION WERE OBSERVED. FOLLOWING THE CTA, AN ECHOCARDIOGRAM WAS PERFORMED THA

    Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Dyspnea; Embolism/Embolus; Muscle Weakness/Atrophy; Thrombosis/Thrombus

    MAUDE report 21919996 ↗
  • MalfunctionApr 25, 2025Activation Failure; Activation Failure

    MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AN INFOLD WAS VISUALLY OBSERVED DURING LOADING. THE NODES INVOLVED IN THE OVERLAP WAS NODES 1-5. THE VALVE WAS ATTEMPTED TO BE RELOADED BUT WAS UNABLE TO BE EXPAND. A SECOND VALVE WAS LOADED ONTO THE SAME DELIVERY CATHETER SYSTEM (DCS) AND USED WITHOUT ISSUES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21907943 ↗

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

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Sources and updates

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