Evolut™ FX+ EVFXPLUS-26Recalls & reported problems

Summary

The FDA's MAUDE database contains 279 adverse event reports that list this exact device (DI 00763000716134), received between May 28, 2024 and Sep 30, 2026 — classified as 46 deaths, 188 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (134 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 279 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Activation Failure; Thickening of Material

  It was reported that the day following the implant of this transcatheter bioprosthetic aortic valve within a pre-existing non-Medtronic transcatheter valve, a computed tomography (CT) was performed. The CT identified a fusiform thickening of the transcatheter aortic valve leaflets. This was consistent with Grade 2-3 hypoattenuated leaflet thickening (HALT). A transthoracic echocardiogram (TTE) was also performed. Baseline medication included anti-coagulation medication. Eliquis and aspirin would continue. The event was reported as resolving. No symptoms occurred due to HALT. The physician indicated the event was causal related to the transcatheter valve and the redo transcatheter valve implant procedure. Additional information indicated that prior to the implant of this transcatheter aortic bioprosthetic valve (TAV), a pre-implant dilatation of the non-Medtronic TAV was performed. During the valve-in-valve procedure, the second TAV was deployed and underexpansion of the Medtronic TAV occurred. A post-implant dilatation was performed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946641 ↗
• InjurySep 25, 2026Device Dislodged or Dislocated

  It was reported that during implant of a transcatheter aortic bioprosthetic valve, the implant depth was 3mm at the non-coronary cusp and 5mm at the left coronary cusp. A post-implant balloon aortic valvuloplasty (BAV) was performed. During the BAV, valve dislodgement occurred. The valve dislodged to the sinus at the level of the sinotubular junction and was snared into the ascending aorta. A second Medtronic valve was implanted at the annulus level. The procedure was delayed by approximately one hour.

  Patient problems: Foreign Body In Patient

  MAUDE report 50897186 ↗
• MalfunctionSep 21, 2026Material Invagination

  It was reported that prior to the attempted implant of a transcatheter aortic valve in a patient with critical stenosis of the native aortic valve, a pre-implant balloon aortic valvuloplasty (BAV) was performed due to the patient's calcified anatomy. Upon the first deployment attempt to 80% deployment, it was observed that the valve had infolded on the left coronary cusp (LCC) side. 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 opened and used. Per the physician, the patient's calcified anatomy contributed to the infold. A 20 minute procedural delay occurred as a result.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841361 ↗
• DeathSep 8, 2026Patient Device Interaction Problem

  It was reported that following the implant of a transcatheter aortic valve through the femoral access site, the patient experienced retroperitoneal bleeding and died. Per the physician, the retroperitoneal bleeding was the cause of death and the patient anatomy, including a large pannus, were identified as contributing factors.

  Patient problems: Retroperitoneal Hemorrhage

  MAUDE report 50677588 ↗
• MalfunctionSep 2, 2026Device Dislodged or Dislocated

  Patient problems: Insufficient Information

  MAUDE report 50566515 ↗
• InjuryAug 14, 2026Patient Device Interaction Problem; Thickening of Material

  It was reported that during the implant procedure of this Medtronic transcatheter bioprosthetic aortic valve, within a pre-existing non-Medtronic valve via the right femoral access, the delivery catheter system (DCS) recaptured the Medtronic valve one time due to a high position. The valve was repositioned and successfully implanted. A post implant balloon valvuloplasty was performed for an unspecified reason. Approximately 45 days following the Medtronic valve-in-valve (VIV) implant, hypoattenuated leaflet thickening (HALT) and thromobosis within the native sinus of the Medtronic valve was identified. At the time of the 30 day visit, the patient remained on an anticoagulant and a low dose aspirin. No actions or interventions were taken. Patient symptoms were not reported. The event remained resolving. The physician indicated the event was causal to the transcatheter valve.

  Patient problems: Insufficient Information; Thrombosis/Thrombus

  MAUDE report 50255261 ↗
• InjuryAug 14, 2026Device Dislodged or Dislocated; Insufficient Device Problem Information; Patient Device Interaction Problem

  It was reported that following the implant of a transcatheter aortic valve, a second valve was implanted valve-in-valve for an unspecified reason. An ID card was sent with the serial number of the valve that was initially implanted, and replaced. Subsequently, the serial number was corrected, and a new ID card with a data correction letter was sent. Approximately 6 days later, a permanent pacemaker was implanted for Brady/Tachy syndrome.

  Patient problems: Bradycardia; Tachycardia

  MAUDE report 50253405 ↗
• InjuryAug 5, 2026No Apparent Adverse Event; Insufficient Device Problem Information

  It was reported that following the implant of a transcatheter aortic valve, the valve was inactivated for an unspecified reason.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50144985 ↗
• InjuryAug 3, 2026Device Dislodged or Dislocated

  It was reported that during the attempted implant of a transcatheter aortic valve into an indwelling non-Medtronic surgical aortic valve (SAV), the valve was successfully positioned at 2 millimeters (mm) on the non-coronary cusp (NCC) and 4 mm on the left coronary cusp (LCC), however it was advised to recapture and place slightly deeper due to the existing plan to perform a post-implant balloon aortic valvuloplasty (BAV) to fracture the SAV. It was ultimately decided to implant the valve at the current position. Following the successful implant, the post-implant BAV was performed with a 23 mm non-Medtronic balloon, however the valve ultimately dislodged into the aortic root. Subsequently, a non-Medtronic valve was implanted. Per the physician, the depth of implant contributed to the dislodgement.

  Patient problems: Foreign Body In Patient

  MAUDE report 50119308 ↗
• InjuryJul 30, 2026Perivalvular Leak; Patient 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 due to the patient's calcified anatomy. Following insertion of the delivery catheter system (DCS) into the patient, on the first deployment attempt, it was observed that the valve was positioned too shallow in relation to the target implant depth. Subsequently, the valve was recaptured into the DCS. Upon the second deployment attempt, the valve was positioned too deep relative to the target implant depth. Subsequently, a second recapture was performed. On the third deployment attempt, the valve was implanted successfully, however paravalvular leak (PVL) of unspecified severity was observed. Subsequently, a post-implant BAV was performed with a non-Medtronic 22 millimeter (mm) balloon. The final angiogram revealed no PVL and patent flow in both coronary arteries. An echocardiogram assessment was being performed when the patient was observed to be hypotensive. Echocardiogram and coronary angiography revealed a partially obstructed left main coronary artery due, resulting in diminished flow. A stent was placed into the left main coronary a

  Patient problems: Cardiovascular Dysfunction/Insufficiency; Coronary obstruction/occlusion; Valvular Insufficiency/ Regurgitation

  MAUDE report 50087289 ↗
• DeathJul 9, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH AORTIC VALVE DISEASE UNDERWENT A TRANSCATHETER AORTIC VALVE IMPLANTATION. THE VALVE WAS REPORTED TO HAVE BEEN SUCCESSFULLY IMPLANTED AT A DEPTH OF 0 AND 1, WITH CORONARIES ASSESSED AS FLOWING WELL AND HEMODYNAMICS REPORTED AS GREAT. THE PATIENT REPORTEDLY DIED APPROXIMATELY 30 MINUTES AFTER THE IMPLANT PROCEDURE. THE ETIOLOGY OF DEATH WAS REPORTED AS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25765559 ↗
• MalfunctionJun 24, 2026Material Invagination; Activation Failure

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE, UPON THE FIRST DEPLOYMENT ATTEMPT, THE VALVE WAS CONSTRAINED AND APPEARED TO HAVE INFOLDED. SUBSEQUENTLY, THE VALVE WAS RECAPTURED, AND THE DELIVERY CATHETER SYSTEM (DCS) WAS WITHDRAWN FROM THE PATIENT. A NEW VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE OPENED AND USED 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 25609709 ↗
• InjuryJun 5, 2026Patient Device Interaction Problem

  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. AS THE VALVE WAS DEPLOYED TO 80% THE PATIENT BECAME UNSTABLE. THE VALVE WAS THEN RECAPTURED AND WITHDRAWN FROM THE PATIENT'S BODY VIA THE DCS. THE PATIENT WAS THEN STABILIZED WITH THE USE OF A NON-MEDTRONIC LEFT VENTRICULAR ASSIST DEVICE AS WELL AS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). AFTER THE PATIENT WAS STABILIZED, A NEW VALVE AND DCS WERE UTILIZED TO COMPLETE THE PROCEDURE.

  Patient problems: Hemodynamic instability

  MAUDE report 25409965 ↗
• DeathJun 5, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 30 MINUTES FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, AN ST ELEVATION WAS OBSERVED. ANGIOGRAPHY REVEALED 90% STENOSIS OF THE LEFT MAIN CORONARY ARTERY. SUBSEQUENTLY, THE ARTERY WAS DILATED, 2 STENTS WERE PLACED, AND THE ARTERY WAS DILATED AGAIN. VASOPRESSORS WERE ADMINISTERED, HOWEVER THE PATIENT WENT INTO CARDIAC ARREST. CHEST COMPRESSIONS WERE PERFORMED AND TEMPORARY PACING WAS ADMINISTERED, HOWEVER THE PATIENT ULTIMATELY DIED. A PROCEDURAL DELAY OF 2 HOURS OCCURRED AS A RESULT. PER THE PHYSICIAN, THE PATIENT'S CALCIFIED ANATOMY CONTRIBUTED TO THE EVENT.

  Patient problems: Cardiac Arrest; Coronary obstruction/occlusion

  MAUDE report 25408025 ↗
• DeathMay 28, 2026Perivalvular Leak; Device Dislodged or Dislocated; Activation Failure; Patient Device Interaction Problem; Unspecified Valve Regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT A NON-MEDTRONIC GUIDEWIRE WAS USED FOR THE PROCEDURE. SEVERE PARAVALVULAR LEAK WAS PRESENT AFTER THE FIRST VALVE DISLODGED. THE SECOND VALVE WAS IMPLANTED AT A DEPTH OF 3 MM ON THE NCC AND 4 MM ON THE LCC. WHILE THE PATIENT WAS IN RECOVERY, CARDIAC ARREST OCCURRED AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. IT WAS IDENTIFIED THAT THE SECOND VALVE DISLODGED FOLLOWING PROLONGED CPR. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT HAD A LOW HEMOGLOBIN BUT DID NOT ACCEPT BLOOD PRODUCTS DUE TO RELIGIOUS REASONS.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Cardiac Arrest

  MAUDE report 25323857 ↗
• InjuryMay 27, 2026Incomplete Coaptation; Intravalvular regurgitation

  IT WAS REPORTED THAT APPROXIMATELY 5 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE INTO AN INDWELLING SURGICAL AORTIC VALVE, THE VALVE FAILED DUE TO POOR LEAFLET COAPTATION, RESULTING IN SEVERE CENTRAL AORTIC REGURGITATION.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 25306437 ↗
• MalfunctionMay 26, 2026Material Invagination

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE, UPON THE FIRST DEPLOYMENT ATTEMPT, AN INFOLD WAS OBSERVED. TWO SUBSEQUENT DEPLOYMENT ATTEMPTS WERE MADE, HOWEVER THE INFOLD WOULD NOT RESOLVE. THE SYSTEM WAS ULTIMATELY WITHDRAWN FROM THE PATIENT FOLLOWING THE THIRD RECAPTURE, AND A NEW VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE LOADED. FOLLOWING LOADING OF THE SECOND SYSTEM, FRAME NODE OVERLAP TO THE FOURTH NODE WAS OBSERVED VISUALLY, CONSTITUTING A MISLOAD. SUBSEQUENTLY, A NEW VALVE AND DCS WERE OPENED. PER THE PHYSICIAN, A 10 MINUTE PROCEDURAL DELAY OCCURRED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25279858 ↗
• InjuryMay 18, 2026Perivalvular Leak; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, IN A PATIENT WITH A PREVIOUSLY IMPLANTED 23-MILLIMETER (MM) NON-MEDTRONIC SURGICAL VALVE, THE DELIVERY CATHETER SYSTEM (DCS) WAS INSERTED INTO THE PATIENT AND ADVANCED TO THE AORTIC ANNULUS. THE VALVE WAS THEN DEPLOYED TO 90% IN THAT IT WAS POSITIONED 6 MM THE AORTIC ANNULUS. AS THE VALVE WAS NEARLY FULLY DEPLOYED, IT MOVED IN THAT IT HAD A FINAL IMPLANT POSITION OF 12 MM FROM THE AORTIC ANNULUS. THE PATIENT WAS NOTED TO HAVE A VALVULAR GRADIENT OF 9 MILLIMETERS OF MERCURY (MMHG). THE ATTENDING PHYSICIAN DECIDED TO COMPLETE THE PROCEDURE. A COUPLE HOURS AFTER THE PROCEDURE, THE PATIENT WAS NOTED TO HAVE A PARAVALVULAR LEAK. IT FURTHER WAS IDENTIFIED THAT VALVE MIGRATION HAD OCCURRED. SUBSEQUENTLY, IT WAS DECIDED TO IMPLANT A SECOND NON-MEDTRONIC TRANSCATHETER VALVE INTO THE PREVIOUSLY IMPLANTED VALVE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 25209377 ↗
• InjuryMay 11, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE, UPON THE FIRST DEPLOYMENT ATTEMPT, IT WAS OBSERVED THAT THE VALVE WAS POSITIONED TOO DEEP. SUBSEQUENTLY, THE VALVE WAS RECAPTURED. TWO SUBSEQUENT DEPLOYMENT ATTEMPTS WERE MADE; HOWEVER, THE POSITIONING WAS DETERMINED TO BE TOO DEEP EACH TIME, REQUIRING TWO RECAPTURES. SUBSEQUENTLY, THE SYSTEM WAS WITHDRAWN FROM THE PATIENT, AND A NEW VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE OPENED AND PREPARED. THE SECOND VALVE WAS SUBSEQUENTLY IMPLANTED SUCCESSFULLY. IT WAS NOTED THAT A 20 MINUTE PROCEDURAL DELAY OCCURRED AS A RESULT OF THE POSITIONING DIFFICULTIES. APPROXIMATELY 2 DAYS LATER, IT CONFIRMED VIA NEUROLOGICAL ASSESSMENT THAT THE PATIENT HAD SUFFERED A STROKE, AND DEVELOPED HEMIPLEGIA OF THE LEFT SIDE AS A RESULT.

  Patient problems: Stroke/CVA

  MAUDE report 25140491 ↗
• DeathMay 7, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 1 DAY FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE PATIENT DIED DUE TO AN UNKNOWN CAUSE. A STROKE WAS SUSPECTED, HOWEVER THE COMPUTED TOMOGRAPHY (CT) SCAN WAS NEGATIVE FOR A STROKE.

  Patient problems: Insufficient Information

  MAUDE report 25112047 ↗
• DeathMay 6, 2026Patient Device Interaction Problem; Migration

  ADDITIONAL INFORMATION WAS RECEIVED THAT PER THE SURGEON, THERE WAS POSSIBLY AN ABSCESS THAT WAS NOT IDENTIFIED THAT COULD HAVE PREDISPOSED THE PATIENT TO THE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 25098634 ↗
• InjuryMay 5, 2026Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE STOKE WAS ISCHEMIC. TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS ADMINISTERED TO TREAT THE STROKE, AND THE ISCHEMIA RESOLVED BUT THE PATIENT HAD ONGOING RIGHT-SIDE WEAKNESS AND WAS UNDERGOING REHABILITATION.

  Patient problems: Muscle Weakness/Atrophy; Stroke/CVA

  MAUDE report 25085120 ↗
• MalfunctionApr 28, 2026Gradient Increase; Activation Failure

  IT WAS REPORTED THAT A TRANSCATHETER AORTIC VALVE WAS IMPLANTED INTO A PREVIOUSLY IMPLANTED SURGICAL VALVE. FOLLOWING IMPLANTATION, A VALVULAR GRADIENT OF 15 MILLIMETERS OF MERCURY (MMHG) WAS IDENTIFIED AS WELL AS VALVE UNDER EXPANSION. SUBSEQUENTLY, A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS COMPLETED WITH A 24-MILLIMETER (MM) NON-MEDTRONIC (TRUE) BALLOON. AFTER THE POST-IMPLANT BAV, A 5 MMHG GRADIENT VALVULAR GRADIENT WAS IDENTIFIED.

  Patient problems: Transvalvular Pressure Gradient Increased

  MAUDE report 25023257 ↗
• InjuryApr 16, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 1 MONTH FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A SURGICAL AORTIC VALVE WAS IMPLANTED FOR AN UNSPECIFIED REASON.

  Patient problems: Insufficient Information

  MAUDE report 24899625 ↗
• DeathApr 11, 2026Insufficient 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 DUE TO CALCIFICATION. THE DELIVERY CATHETER SYSTEM (DCS) WAS THEN INSERTED INTO THE PATIENT AND ADVANCED TO THE NATIVE AORTIC ANNULUS. THE VALVE WAS THEN PARTIALLY DEPLOYED IN THAT IT WAS POSITIONED APPROXIMATELY 4 MILLIMETERS (MM) FROM THE NON-CORONARY CUSP (NCC) AND 4 MM FROM THE LEFT CORONARY CUSP (LCC). DESPITE FOLLOWING TRAINING GUIDANCE FOR SLOW DEPLOYMENT OF THE VALVE AND CENTERING OF THE DCS NOSECONE BY SLIGHTLY RETRACTING THE GUIDEWIRE, THE NOSECONE SUDDENLY MOVED DURING FINAL DEPLOYMENT, CAUSING DCS INTERACTION WITH THE VALVE. THIS INTERACTION CAUSED THE VALVE TO EMBOLIZE INTO THE PATIENT'S ASCENDING AORTA. SUBSEQUENTLY, THE ATTENDING PHYSICIAN OPTED TO ATTEMPT IMPLANTATION OF A SECOND VALVE, SO A NEW VALVE WAS PREPARED AND LOADED INTO THE DCS. AS THE DCS WAS ADVANCED TOWARDS THE AORTIC ANNULUS, THE PREVIOUSLY DISLODGED VALVE BECAME UNSTABLE. THEREFORE, A SNARE WAS UTILIZED TO GRASP THE DISLODGED VALVE TO MAINTAIN ITS POSITION IN RELATION TO THE GREAT VESSELS AS THE SECOND VALVE WAS SUCCESSFULLY IMPLANTED. AFTER IMPLANTATION OF THE SE

  Patient problems: Cardiac Arrest; Pericardial Effusion; Rupture

  MAUDE report 24847844 ↗

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-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-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