CoreValve™ Evolut™ R EVOLUTR-26-US (UDI 00763000017668)Recalls & reported problems

Summary

The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 00763000017668), received between May 16, 2018 and Sep 17, 2026 — classified as 10 deaths, 87 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (30 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 107 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Device Stenosis

  Patient problems: Aortic Valve Stenosis

  MAUDE report 50808709 ↗
• DeathJun 9, 2026Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT 7 YEARS AND 2 MONTHS FOLLOWING THE IMPLANTATION OF A TRANSCATHETER AORTIC VALVE, THE PATIENT WAS NOTED TO BE HYPERNATREMIC WITH SODIUM LEVELS OF 142,150, AND 147 MILLIMOLES PER LITRE (MMOL/L). ON THE SAME DAY THE PATIENT WAS NOTED TO BE HYPERNATREMIC, THE PATIENT EXPERIENCED CARDIAC ARREST. SUBSEQUENTLY, THE PATIENT WAS ADMINISTERED VASOPRESSOR MEDICATION UNTIL THEIR FAMILY DECIDED TO WITHDRAW CARE. ULTIMATELY, THE PATIENT DIED.

  Patient problems: Cardiac Arrest; Hypernatremia

  MAUDE report 25452097 ↗
• InjuryMar 30, 2026Calcified; Activation Failure; Thickening of Material; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 11 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO SEVERE STENOSIS AND MODERATE CENTRAL AORTIC REGURGITATION. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS 26 MILLIMETER (MM) TRANSCATHETER VALVE WAS IMPLANTED IN A PREVIOUSLY IMPLANTED NON-MED TRONIC SURGICAL AORTIC VALVE. PER THE PHYSICIAN, TRANSCATHETER VALVE LEAFLETS APPEARED THICKENED AND PARTIALLY CALCIFIED. ADDITIONALLY, THE VALVE FRAME DID NOT LOOK FULLY EXPANDED. SUBSEQUENTLY, A 23 MM NON-MEDTRONIC TRANSCATHETER VALVE WAS IMPLANTED AS TREATMENT.

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

  MAUDE report 24734394 ↗
• InjuryJan 22, 2026Fluid/Blood Leak; Perivalvular Leak

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 11 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, REGURGITATION OF SEVERE SEVERITY WAS IDENTIFIED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24150172 ↗
• InjuryDec 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED THAT 6 YEARS AND 2 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 23795292 ↗
• InjuryOct 27, 2025Perivalvular Leak; Patient Device Interaction Problem; Material Split, Cut or Torn; Intravalvular regurgitation; Perivalvular Leak; Patient Device Interaction Problem; Material Split, Cut or Torn; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 6 MONTHS FOLLOWING THE IMPLANT OF A 26 MILLIMETER (MM) TRANSCATHETER VALVE IN A PREVIOUSLY IMPLANTED 25 MM NON-MEDTRONIC SURGICAL AORTIC VALVE, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO INCREASED DYSPNEA, AND FLUID RETENTION. A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED THAT REVEALED SEVERE CENTRAL AORTIC REGURGITATION, DECREASED LEFT VENTRICULAR EJECTION FRACTION (EF), AND ENLARGED INFERIOR VENA CAVA WITH NO RESPIRATORY COLLAPSE. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED THAT REVEALED THE MECHANISM OF AORTIC REGURGITATION TO BE CUSP DEGENERATION WITH LEAFLET RETRACTION AND LIKELY LEAFLET TEAR. ADDITIONALLY, MILD ANTERIOR PARAVALVULAR LEAK (PVL) WAS OBSERVED AND THERE WAS NO EVIDENCE OF ENDOCARDITIS. AN ELECTROCARDIOGRAM (ECG) WAS ALSO PERFORMED THAT REVEALED NEW ATRIAL FIBRILLATION (AFIB). FOUR DAYS FOLLOWING THE TTE, TEE AND ECG, A POSITRON EMISSION TOMOGRAPHY (PET) SCAN WITH COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED THAT REVEALED NO CONVINCING FINDINGS FOR INFECTIVE ENDOCARDITIS. SUBSEQUENTLY, THE PATIENT WAS ADMINISTERED SUBCUTANEOUS (SQ) HEPARIN, AND A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE WAS P

  Patient problems: Atrial Fibrillation; Cusp Tear; Dyspnea; Swelling/ Edema; Valvular Insufficiency/ Regurgitation

  MAUDE report 23391721 ↗
• InjuryJun 25, 2025Perivalvular Leak; Intravalvular regurgitation; Perivalvular Leak; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE SEVERITY OF THE PARAVALVULAR LEAK (PVL) WAS SEVERE, AND A NON-MEDTRONIC TRANSCATHETER V ALVE WAS SUBSEQUENTLY IMPLANTED VALVE-IN-VALVE.

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

  MAUDE report 22331132 ↗
• InjuryJun 3, 2025Fluid/Blood Leak; Patient Device Interaction Problem; Intravalvular regurgitation; Fluid/Blood Leak; Patient Device Interaction Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 9 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT WAS HOSPITALIZED DUE TO HEART FAILURE EXACERBATION AND AORTIC INSUFFICIENCY. APPROXIMATELY 2 DAYS LATER, A VALVE-IN-VALVE PROCEDURE WAS PERFORMED AS TREATMENT.

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

  MAUDE report 22132988 ↗
• InjuryMay 29, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 5 YEARS AND 7 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, VALVE STENOSIS WAS NOTED. NO PATIENT COMPLICATION HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Stenosis

  MAUDE report 22104882 ↗
• InjuryMay 2, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS, 1 MONTH, AND 12 DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, SEVERE CENTRAL AORTIC REGURGITATION WAS NOTED. SUBSEQUENTLY, A VALVE-IN-VALVE PROCEDURE WAS PERFORMED AND A SECOND VALVE WAS IMPLANTED IN THE PATIENT.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 21952141 ↗
• InjuryApr 1, 2025Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT THIS TRANSCATHETER BIOPROSTHETIC VALVE IMPLANT WAS IMPLANTED WITHIN A NON-MEDTRONIC SURGICAL VALVE. APPROXIMATELY 1 YEAR AND 1 MONTH FOLLOWING THE IMPLANT OF TRANSCATHETER VALVE A TRANSTHORACIC ECHOCARDIOGRAM (TTE) IDENTIFIED AN EJECTION FRACTION (EF) OF 65%, A MEAN GRADIENT (MG) OF 22 MILLIMETERS OF MERCURY (MM HG), A PEAK VELOCITY OF 3.37 METERS PER SECOND (M/S). MINIMAL MITRAL VALVE REGURGITATION (MR) AND MINIMAL TRICUSPID REGURGITATION (TR) WERE NOTED. THERE WAS NO AORTIC VALVE REGURGITATION (AR). AN ANTICOAGULANT WAS STARTED. A COMPUTED TOMOGRAPHY (CT) PERFORMED APPROXIMATELY 2 WEEKS LATER INDICATED HYPOATTENUATED LEAFLET AND THROMBUS WERE NOT PRESENT. THE ANTI-COAGULANT WAS CONTINUED. WITH THE RETURN VISIT TO THE CLINIC APPROXIMATELY 4 MONTHS LATER A TTE MEASURED AN EF OF 75%, AN MG OF 25 MMHG, AND A PEAK VELOCITY OF 3.3 M/S. THERE WAS MILD MR AND MINIMAL TR. AORTIC REGURGITATION WAS ABSENT. THE PATIENT REMAINED ON THE ANTICOAGULANT. APPROXIMATELY 6 MONTHS LATER, AT THE 7-YEAR VISIT, THE TTE MEASURED AN EF 70%, A MG OF 28 MMHG, AND A PEAK VELOCITY OF 3.8 M/S. MILD TR WAS PRESENT, HOWEVER, THERE WAS NO AR OR MR. THE PATIENT REPORTED NO SHORTNE SS OF BREATH

  Patient problems: Chest Pain; Mitral Valve Insufficiency/ Regurgitation; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 21746910 ↗
• MalfunctionFeb 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN TIME, THE VALVE DISLODGED. NO TREATMENT WAS REPORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21355084 ↗
• InjuryFeb 5, 2025Gradient Increase; Patient Device Interaction Problem; Intravalvular regurgitation; Gradient Increase; Patient Device Interaction Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 5 YEARS, 4 MONTHS, AND 2 WEEKS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE WITHIN A PRE-EXISTING NON-MEDTRONIC SURGICAL AORTIC VALVE, A LOW CARDIAC OUTPUT WAS OBSERVED. THE FOLLOWING DAY, SEVERE CENTRAL AORTIC REGURGITATION AND AN ELEVATED GRADIENT WERE ALSO NOTED. TWO DAYS LATER, INTERVENTION IN THE FORM OF A VALVE-IN-VALVE PROCEDURE WAS PERFORMED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Low Cardiac Output; Transvalvular Pressure Gradient Increased

  MAUDE report 21313103 ↗
• MalfunctionJan 14, 2025Gradient Increase; Patient Device Interaction Problem; Gradient Increase; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE INTO A PATIENT WITH AN EXISTING MEDTRONIC SURGICAL TISSUE VALVE, THE MEAN GRADIENT ACROSS THE MITRAL VALVE MEASURED 11MMHG WITHOUT ANY OBVIOUS MITRAL REGURGITATION(MR). DIFFICULTY TO ASSESS VIA ECHOCARDIOGRAM (ECHO) WAS REPORTED. EJECTION FRACTION (EF) MEASURED 36%. IT WAS REPORTED THE PATIENT HAD AN EXCELLENT RECOVERY. TWENTY-EIGHT DAYS POST IMPLANT, A FOLLOW UP ECHO SHOWED AN EF OF 56% WITH A MEAN GRADIENT ACROSS THE MITRAL VALVE OF 10MMHG. AGAIN, THE SEVERITY OF THE MR WAS DIFFICULT TO ASSESS. IT WAS NOTED THE PATIENT FELT MUCH BETTER; HOWEVER, THE PATIENT DEVELOPED HEART FAILURE SYMPTOMS. FIVE MONTHS AND EIGHT DAYS LATER, ANOTHER FOLLOW UP ECHO WAS PERFORMED SHOWING A MEAN GRADIENT ACROSS THE MITRAL VALVE OF 13MMHG. MODERATE-SEVERE MITRAL REGURGITATION WAS OBSERVED. THE MEAN GRADIENT ACROSS THE PATIENT¿S AORTIC VALVE WAS STABLE AT 24MMHG WITH NO SIGNIFICANT PERIVALVULAR LEAK. DUE TO THE PATIENT¿S PROGRESSIVE SYMPTOMS AND BIOPROSTHETIC MITRAL VALVE FAILURE, THE PHYSICIAN CHOSE TO PERFORM TRANSSEPTAL TRANSCATHETER MITRAL VALVE REPLACEMENT AND CONSIDERED THE PATIENT TO BE AT HIGH RI

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 21147916 ↗
• MalfunctionJan 7, 2025Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT FOUR YEARS AND NINE MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE INTO A PATIENT WITH AN EXISTING NON-MEDTRONIC SURGICAL AORTIC VALVE, CALCIFICATION WAS NOTED IN THE AORTIC ANNULUS UNDER NON-CORONARY CUSP (NCC) EXTENDING INTO THE LEFT VENTRICULAR OUTFLOW TRACT AND IN THE PROXIMAL RIGHT CORONARY ARTERY. THE IMPLANT DEPTH WAS 4MM ON THE NCC AND 0MM ON THE LEFT CORONARY CUSP. IT WAS NOTED THAT IMAGING WAS PERFORMED DUE TO HIGH GRADIENTS. THE MEAN GRADIENT WAS 40.7 MILLIMETERS OF MERCURY (MMHG). THERE WAS NO EVIDENCE OF THROMBUS OR LEAFLET THICKENING ON THE BIOPROSTHETIC VALVE. NO INTERVENTION WAS PERFORMED OR SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21093790 ↗
• InjuryNov 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE WEEK FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED IN THE PATIENT DUE TO COMPLETE HEART BLOCK.

  Patient problems: Heart Block

  MAUDE report 20787324 ↗
• InjuryNov 19, 2024Fluid/Blood Leak; Material Split, Cut or Torn; Intravalvular regurgitation; Fluid/Blood Leak; Material Split, Cut or Torn; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 5 YEARS AND 1 MONTHS FOLLOWING THE IMPLANT OF THE EVOLUTR-26-US VALVE, THE PATIENT EXPERIENCED A TORN LEAFLET RESULTING IN SEVERE AORTIC INSUFFICIENCY. THE PATIENT UNDERWENT HOSPITALIZATION DUE TO THIS CONDITION. IT WAS NOTED THAT THE MEDTRONIC DEVICE WAS IMPLICATED IN THE SYMPTOMS. A TREATMENT INTERVENTION WAS PLANNED, INVOLVING A TAV-TAV PROCEDURE WITH AN NON-MEDTRONIC VALVE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE AORTIC INSUFFICIENCY WAS CENTRAL, AND THE VALVE-IN-VALVE PROCEDURE WAS SUCCESSFULLY PERFORMED.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 20724780 ↗
• InjuryNov 13, 2024Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED DUE TO CALCIFICATION. SUBSEQUENTLY, THE VALVE AS IMPLANTED IN THE PATIENT. APPROXIMATELY 4 YEARS AND 10 MONTHS LATER, VALVE STENOSIS WAS NOTED AND A SECOND VALVE WAS IMPLANTED IN THE PATIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674411 ↗
• InjuryNov 1, 2024Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) WAS PERFORMED. SEVERE STENOSIS WITH SYMPTOMATIC AORTIC STENOSIS WAS REPORTED. THE FOLLOWING DAY A NON-MEDTRONIC TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANT VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 20593864 ↗
• MalfunctionOct 29, 2024Degraded; Degraded

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 3 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE FAILED DUE TO AN UNKNOWN REASON. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20557340 ↗
• InjuryOct 18, 2024Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 5 YEARS AND 20 DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE WITHIN A PRE-EXISTING NON-MEDTRONIC SURGICAL AORTIC VALVE, SEVERE CENTRAL AORTIC REGURGITATION WAS NOTED. SUBSEQUENTLY, BOTH VALVES WERE EXPLANTED AND A NEW NON-MEDTRONIC SURGICAL AORTIC VALVE WAS IMPLANTED IN THE PATIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 20482037 ↗
• InjuryOct 7, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 5 MONTHS AND 3 WEEKS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO ATRIO-VENTRICULAR BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 20384976 ↗
• MalfunctionSep 19, 2024Degraded; Device Stenosis; Degraded; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 5 YEARS, 1 MONTHS, AND 3 WEEKS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AN UNSPECIFIED VALVE FAILURE OCCURRED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 20257771 ↗
• InjuryApr 25, 2024Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY FIVE YEARS AND SEVEN MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE IN A PATIENT WITH PREVIOUS NON-MEDTRONIC AORTIC VALVE REPLACEMENT, AORTIC STENOSIS WAS IDENTIFIED. SUBSEQUENTLY, A NEW VALVE WAS IMPLANTED VALVE-IN-VALVE. FOLLOWING VALVE IMPLANT, A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED FOR VALVE EXPANSION USING A 20 MM NON-MEDTRONIC BALLOON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Valvular Stenosis

  MAUDE report 19182915 ↗
• InjuryApr 25, 2024Gradient Increase; Device Stenosis; Gradient Increase; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT FOUR YEARS AND ONE MONTH FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE FAILED. THE FAILURE MODE WAS SEVERE AORTIC STENOSIS AND HIGH GRADIENTS. THE VALVE'S DEPTH OF IMPLANT CONTRIBUTED TO THE PATIENT SYMPTOMS. TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WAS PLANNED AS A TREATMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Transvalvular Pressure Gradient Increased

  MAUDE report 19179505 ↗

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, Labeled as
• 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 CE
• 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 B
• 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