Evolut™ FX+ EVFXPLUS-34Recalls & reported problems

Summary

The FDA's MAUDE database contains 344 adverse event reports that list this exact device (DI 00763000716158), received between Jun 20, 2024 and Sep 30, 2026 — classified as 7 deaths, 143 injuries, 194 malfunctions.

The most frequently reported specific device problem is “Material Invagination” (183 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 344 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952129 ↗
• MalfunctionSep 30, 2026Material Invagination

  It was reported that prior to the attempted implant of a transcatheter aortic valve, a pre-implant balloon aortic valvuloplasty (BAV) was performed due to the patient's calcified anatomy. Upon the first deployment attempt, an infold was identified at a target implant depth of 3 millimeters (mm) on the non-coronary cusp (NCC) and 3 mm on the left coronary cusp (LCC). Subsequently, the valve was recaptured into the delivery catheter system (DCS), and the system was withdrawn from the patient. A new valve and DCS were then opened and used. A 6-minute procedural delay occurred as a result.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951581 ↗
• InjurySep 29, 2026Patient Device Interaction Problem

  It was reported that prior to the attempted implant of a transcatheter aortic valve, a pre-implant balloon aortic valvuloplasty (BAV) was performed with a non-Medtronic 23 millimeter (mm) balloon due to the patient's calcified and bicuspid native valve. Upon deployment of the first 3-4 nodes of the valve, it was identified that the valve was positioned too high relative to the target implant depth of 2 mm on the non-coronary cusp (NCC) and 3 mm on the left coronary cusp (LCC). Subsequently, the valve was recaptured into the delivery catheter system (DCS). Upon the second deployment attempt, an infold was identified. Subsequently, the valve was recaptured, and the system was withdrawn from the patient. An additional pre-implant BAV was performed with a non-Medtronic 25 mm balloon, and a new valve and DCS were opened and prepped. The second valve was implanted successfully, however the patient went into complete heart block (CHB) following the release of the valve. The following day, a permanent pacemaker was implanted for the CHB. Per the physician, the patient's bicuspid native valve and calcified anatomy contributed to the infold. A 10 minute procedural delay occurred as a result.

  Patient problems: Heart Block

  MAUDE report 50936256 ↗
• MalfunctionSep 29, 2026Material Invagination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936157 ↗
• InjurySep 28, 2026Patient Device Interaction Problem

  It was reported that following the implant of a transcatheter aortic valve, the patient suffered a stroke. No further details were provided.

  Patient problems: Stroke/CVA

  MAUDE report 50915466 ↗
• InjurySep 23, 2026Patient Device Interaction Problem

  It was reported that prior to the attempted implant of a transcatheter aortic valve in a patient with a recent history of 1st degree atrio-ventricular (AV) block, hospitalization due to paroxysmal atrial fibrillation with electrical cardioversion, and an active left bundle branch block (LBBB), a wide QRS complex was noted upon performance of a pre-implant balloon aortic valvuloplasty (BAV) and insertion of the guidewire. The valve was ultimately implanted successfully, and a bi-ventricular permanent pacemaker was implanted the following day.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 50871590 ↗
• MalfunctionSep 17, 2026Material Invagination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810794 ↗
• MalfunctionSep 2, 2026Material Invagination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50565623 ↗
• MalfunctionAug 26, 2026Material Invagination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459636 ↗
• InjuryAug 14, 2026Patient Device Interaction Problem

  It was reported that an unspecified amount of time following the implant of a transcatheter aortic valve, endocarditis was identified. Approximately 9 months following the implant of the valve, and an unspecified amount of time following the identification of endocarditis, the valve was explanted. Subsequently, a surgical aortic valve was implanted.

  Patient problems: Endocarditis

  MAUDE report 50254413 ↗
• InjuryJul 30, 2026Device Dislodged or Dislocated

  It was reported that during a femoral transcatheter aortic valve implantation procedure, the first valve was positioned at a 3 millimeter (mm) implant depth at 80% deployment, and upon paddle release the valve dislodged up above the annulus. The valve was snared to the ascending aorta. A second transcatheter aortic valve was implanted valve-in-valve.

  Patient problems: Foreign Body In Patient

  MAUDE report 50082718 ↗
• InjuryJul 29, 2026Patient Device Interaction Problem

  It was reported that 4 days following the implant of this transcatheter bioprosthetic aortic valve within a pre-existing Medtronic transcatheter valve, the patient presented to the emergency department with non-cardiac chest pain and a hypertensive emergency. The systolic blood pressure measured in the range of 210  millimeters of mercury (mm Hg) and the diastolic blood pressure was >100 mmHg. The chest pain was a short lived episode of midsternal, non-radiating chest pressure, shortness of breath, dyspnea on exertion, and mild low extremity swelling. An electrocardiogram (ECG) showed no evidence of obvious ST elevations to indicate acute ischemia or infarct. Troponins were reported as ¿flat¿ which measured 45 and 41. The B-type natriuretic peptide (BNP) was minimally elevated at 149. Intravenous diuretics and a nitroglycerin drip were administered. Cardiology was consulted. Hospitalization was required and was prolonged by the hypertensive event. Discharge occurred 2 days following admission. The chest pain event was reported causal related to the transcatheter valve. The hypertensive event was reported as unrelated to the Medtronic products and the implant procedure. The cause wa

  Patient problems: Cardiac Enzyme Elevation; Chest Pain; Dyspnea; High Blood Pressure/ Hypertension; Peripheral Edema

  MAUDE report 50069191 ↗
• InjuryJul 28, 2026Activation Failure

  Medtronic received information that five years and five months following the implant of this transcatheter bioprosthetic valve, a failed valve was identified. The primary mode of valve failure was reported as structural valve dysfunction (SVD), mixed aortic stenosis (AS)/aortic regurgitation (AR) with moderate hemodynamic valve deterioration (HVD), specified as a new occurrence or increase of >=1 grade of intra-prosthetic AR resulting in >=moderate AR. It was noted that following the implant of this valve no paravalvular leak (PVL) observed. Two months and fifteen days later, a second Medtronic transcatheter aortic valve (TAV) was implanted valve-in-valve. Additional information confirmed that during the valve-in-valve (VIV) procedure, a pre-ballooning of the pre-existing Medtronic valve was performed. The Medtronic replacement valve was then implanted. This new valve was reported to be in the correct position, both within the proper and desired anatomical location. A post-ballooning of this new, active Medtronic valve was performed due to under expansion. The patient was discharged on the same date as the VIV.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50061235 ↗
• MalfunctionJul 1, 2026Material Invagination

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE, ON THE FIRST DEPLOYMENT ATTEMPT, THE VALVE WAS POSITIONED TOO SHALLOW IN RELATION TO THE TARGET IMPLANT DEPTH. SUBSEQUENTLY, THE VALVE WAS RECAPTURED INTO THE DELIVERY CATHETER SYSTEM (DCS). UPON THE SECOND DEPLOYMENT ATTEMPT, AN INFOLD WAS IDENTIFIED AT A TARGET IMPLANT DEPTH OF 3 MILLIMETERS (MM). SUBSEQUENTLY, THE VALVE WAS RECAPTURED INTO THE DCS, AND THE SYSTEM WAS WITHDRAWN FROM THE PATIENT. A NEW VALVE AND DCS WERE OPENED AND USED. PER THE PHYSICIAN, THE PATIENT'S CALCIFIED ANATOMY CONTRIBUTED TO THE EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25680015 ↗
• InjuryJun 30, 2026Perivalvular Leak; Patient Device Interaction Problem

  IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A NON-MEDTRONIC 24 MILLIMETER (MM) BALLOON. FOLLOWING THE SUCCESSFUL IMPLANT OF THE VALVE AT 8 MM ON THE NON-CORONARY CUSP (NCC) AND 16 MM ON THE LEFT CORONARY CUSP (LCC), MODERATE PARAVALVULAR LEAK (PVL) WAS OBSERVED VIA ECHOCARDIOGRAM. SUBSEQUENTLY, A POST-IMPLANT BAV WAS PERFORMED WITH A NON-MEDTRONIC BALLOON, AND A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE. A MEAN GRADIENT OF 38 MILLIMETERS OF MERCURY (MM HG) WAS REPORTED FOLLOWING THE IMPLANT OF THE SECOND VALVE. PER THE PHYSICIAN, THE PATIENT'S BICUSPID NATIVE VALVE AND THE DEPTH OF IMPLANT CONTRIBUTED TO THE EVENT. IT WAS NOTED A 15 MINUTE PROCEDURAL DELAY OCCURRED AS A RESULT. APPROXIMATELY 2 DAYS LATER, A PERMANENT PACEMAKER WAS IMPLANTED FOR SICK SINUS SYNDROME.

  Patient problems: Non specific EKG/ECG Changes; Valvular Insufficiency/ Regurgitation

  MAUDE report 25667992 ↗
• MalfunctionJun 18, 2026Material Invagination; Activation Failure

  IT WAS REPORTED THAT PRIOR TO THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED DUE TO THE PATIENT'S CALCIFIED ANATOMY. UPON THE FIRST DEPLOYMENT ATTEMPT, IT WAS NOTED THAT THE VALVE APPEARED COMPRESSED. SUBSEQUENTLY, THE VALVE WAS RECAPTURED INTO THE DELIVERY CATHETER SYSTEM (DCS). UPON THE SECOND DEPLOYMENT ATTEMPT, AN INFOLD WAS OBSERVED AT A TARGET IMPLANT DEPTH OF 3 MILLIMETERS (MM). SUBSEQUENTLY, THE VALVE WAS RECAPTURED A SECOND TIME, AND THE SYSTEM WAS WITHDRAWN FROM THE PATIENT. A NEW VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE OPENED AND PREPARED. PER THE PHYSICIAN, THE PATIENT'S CALCIFIED ANATOMY CONTRIBUTED TO THE INFOLD/EXPANSION ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25547249 ↗
• InjuryMay 28, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, AN AORTIC DISSECTION WAS IDENTIFIED. SUBSEQUENTLY, MEDICATION WAS ADMINISTERED TO TREAT THE DISSECTION. PER THE PHYSICIAN, THE PATIENT'S CALCIFICATION AND BICUSPID NATIVE VALVE CONTRIBUTED TO THE DISSECTION.

  Patient problems: Aortic dissection

  MAUDE report 25322047 ↗
• InjuryMay 18, 2026Perivalvular Leak; Activation Failure; Patient Device Interaction Problem

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, IT WAS OBSERVED THAT THE VALVE WAS CONSTRAINED, AND THERE WAS STILL PARAVALVULAR LEAK (PVL) OF UNSPECIFIED SEVERITY. SUBSEQUENTLY, A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A NON-MEDTRONIC 24 MILLIMETER (MM) BALLOON. UPON CLOSURE OF THE ACCESS SIDE, THE PATIENT'S BLOOD PRESSURE DROPPED. IT WAS OBSERVED VIA ECHOCARDIOGRAM THAT PERICARDIAL EFFUSION HAD OCCURRED, AND AN ANNULAR RUPTURE WAS LATER CONFIRMED. SUBSEQUENTLY, THE VALVE WAS EXPLANTED AND THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT (ICU).

  Patient problems: Pericardial Effusion; Rupture; Valvular Insufficiency/ Regurgitation

  MAUDE report 25203975 ↗
• MalfunctionMay 15, 2026Material Invagination; Activation Failure

  IT WAS REPORTED THAT PRIOR TO THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 24 MILLIMETER (MM) BALLOON. UPON DEPLOYMENT OF THE VALVE TO 80% AT A DEPTH OF 4 MM ON THE NON-CORONARY CUSP (NCC) AND 5 MM ON THE LEFT CORONARY CUSP (LCC), THE VALVE WAS EXTREMELY CONSTRAINED, AND IT APPEARED THERE WAS AN INFOLD. SUBSEQUENTLY, THE VALVE WAS RECAPTURED INTO THE DELIVERY CATHETER SYSTEM (DCS) AND THE SYSTEM WAS WITHDRAWN FROM THE PATIENT. SUBSEQUENTLY, AN ADDITIONAL PRE-IMPLANT BAV WAS PERFORMED WITH A 26 MM BALLOON. A NEW VALVE AND DCS WERE OPENED AND USED TO COMPLETE THE PROCEDURE. IT WAS NOTED THAT A 15 MINUTE PROCEDURAL DELAY OCCURRED AS A RESULT. PER THE PHYSICIAN, THE PATIENT'S NATIVE BICUSPID VALVE CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25190285 ↗
• MalfunctionMay 14, 2026Material Invagination

  IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED DUE TO CALCIFICATION. UPON FLUOROSCOPIC INSPECTION OF THE VALVE LOAD, AN INFOLD WAS NOT DEFINITIVELY CONFIRMED. UPON THE FIRST DEPLOYMENT ATTEMPT, AN INFOLD WAS IDENTIFIED. FOLLOWING THE IMPLANT OF THE VALVE AND AFTER REMOVING THE DELIVERY CATHETER SYSTEM (DCS), A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED THAT CONFIRMED THE INFOLD IN THE VALVE FRAME SUBSEQUENTLY, A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED WITH A 24 MILLIMETER (MM) BALLOON TO RESOLVE THE INFOLD. IT WAS LATER IDENTIFIED THAT FRAME NODE OVERLAP TO THE 4TH NODE OCCURRED DURING LOADING OF THIS VALVE, CONSTITUTING A MISLOAD THAT WAS NOT IDENTIFIED AND THE MISLOADED VALVE AND DCS WERE USED FOR IMPLANTATION. IT WAS NOTED THAT THE MISLOAD WAS NOT DUE TO A NEW VALVE LOADER. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25174417 ↗
• InjuryMay 12, 2026Material Invagination

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE, UPON THE FIRST DEPLOYMENT ATTEMPT AT A TARGET IMPLANT DEPTH OF 2 MILLIMETERS (MM) ON THE NATIVE ANNULUS, AN INFOLD WAS IDENTIFIED. SUBSEQUENTLY, THE VALVE WAS RECAPTURED, AND THE SYSTEM WAS WITHDRAWN FROM THE PATIENT. IT WAS NOTED THAT "ECHMO" WAS PROVIDED AS A TREATMENT. SUBSEQUENTLY, A NEW VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE OPENED AND PREPARED. FOLLOWING INSERTION INTO THE PATIENT, IT WAS OBSERVED THAT THE CORRECT POSITIONING OF THE VALVE COULD NOT BE ACHIEVED. 4 DEPLOYMENT ATTEMPTS WERE MADE, HOWEVER CORRECT POSITIONING WAS NOT ACHIEVED ON ANY OF THE 4 ATTEMPTS. SUBSEQUENTLY, THE VALVE WAS RECAPTURED FOR A FINAL TIME, AND THE SYSTEM WAS WITHDRAWN FROM THE PATIENT. PER THE PHYSICIAN, THE PATIENT'S NATIVE BICUSPID VALVE CONTRIBUTED TO THE INFOLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150937 ↗
• MalfunctionMay 6, 2026Material Invagination

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS COMPLETED DUE TO IT BEING STANDARD FOR THE IMPLANTING PHYSICIAN. THE DELIVERY CATHETER SYSTEM (DCS) WAS THEN INSERTED INTO THE PATIENT AND ADVANCED TO THE AORTIC ANNULUS. THE VALVE WAS THEN DEPLOYED IN THAT IT WAS POSITIONED 7-MILLIMETERS (MM) FROM THE NON-CORONARY CUSP (NCC) AND 7 MM LEFT CORONARY CUSP (LCC). IT WAS THEN IDENTIFIED THAT THE VALVE WAS POSITIONED TOO DEEP IN RELATION TO THE AORTIC ANNULUS. SUBSEQUENTLY, THE VALVE WAS RECAPTURED AND PARTIALLY DEPLOYED IN THAT IT WAS 3 MM FROM THE AORTIC ANNULUS. WHILE DEPLOYING THE VALVE, IT WAS IDENTIFIED THAT AN INFOLD HAD OCCURRED. SUBSEQUENTLY, THE VALVE WAS RECAPTURED INTO THE DCS AND THE DCS WAS REMOVED FROM THE PATIENT. IN RESPONSE, A NEW VALVE AND DCS WERE PREPARED. THE NEW VALVE WAS THEN SUCCESSFULLY IMPLANTED AT A FINAL IMPLANT DEPTH OF 3 MM FROM THE AORTIC ANNULUS. A 4 MINUTE PROCEDURAL DELAY OCCURRED DUE TO THE VALVE INFOLD AND POSITIONING DIFFICULTIES. PER THE PHYSICIAN, THE RECAPTURE AFTER INITIAL DEPLOYMENT CONTRIBUTED TO THE INFOLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107593 ↗
• MalfunctionMay 5, 2026Material Invagination

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS COMPLETED DUE TO CALCIFICATION. THE DELIVERY CATHETER SYSTEM (DCS) WAS THEN INSERTED INTO THE PATIENT AND ADVANCED TO THE AORTIC ANNULUS. THE VALVE WAS THEN DEPLOYED AT A TARGET IMPLANT DEPTH OF 3-MILLIMETERS (MM). DURING DEPLOYMENT AN INFOLD WAS NOTED. SUBSEQUENTLY , THE VALVE WAS RECAPTURED AND WITHDRAWN FROM THE PATIENT'S BODY ALONG WITH THE DCS. A NEW VALVE AND DCS WERE THEN UTILIZED TO COMPLETE THE PROCEDURE. PER THE PHYSICIAN, THE PATIENT'S CALCIFIED ANATOMY CONTRIBUTED TO THE EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25088455 ↗
• MalfunctionApr 23, 2026Material Invagination

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, THE DELIVERY CATHETER SYSTEM (DCS) WAS INSERTED INTO THE PATIENT AND ADVANCED TO THE AORTIC ANNULUS. THE VALVE WAS PARTIALLY DEPLOYED IN THAT IT WAS POSITIONED 3 MILLIMETER'S (MM) FROM THE AORTIC ANNULUS. DURING DEPLOYMENT AN INFOLD WAS NOTED. SUBSEQUENTLY, THE VALVE WAS RECAPTURED AND REMOVED FROM THE PATIENT'S BODY. A NEW VALVE AND DCS WERE THEN UTILIZED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24973566 ↗
• MalfunctionApr 21, 2026Material Invagination

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE AT A TARGET IMPLANT DEPTH OF 3 MILLIMETERS (MM), THE VALVE WAS RECAPTURED FOLLOWING ONE DEPLOYMENT ATTEMPT FOR AN UNSPECIFIED REASON. UPON THE SECOND DEPLOYMENT ATTEMPT, AN INFOLD OF THE VALVE WAS OBSERVED. SUBSEQUENTLY, THE VALVE WAS RECAPTURED, AND THE SYSTEM WAS WITHDRAWN FROM THE PATIENT. A NEW VALVE WAS LOADED INTO A NEW DELIVERY CATHETER SYSTEM (DCS) IN ORDER TO COMPLETE THE PROCEDURE. PER THE PHYSICIAN, THE PATIENT'S CALCIFIED ANATOMY CONTRIBUTED TO THE INFOLD. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE WAS RECAPTURED FOLLOWING THE FIRST DEPLOYMENT ATTEMPTED DUE TO THE VALVE BEING TOO AORTIC. PER THE PHYSICIAN, THE PATIENT'S ANATOMY, SPECIFICALLY BICUSPID NATIVE VALVE, CONTRIBUTED TO THE INFOLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24945223 ↗

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-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-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-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