Evolut™ FX+ EVFXPLUS-29Recalls & reported problems

Summary

The FDA's MAUDE database contains 465 adverse event reports that list this exact device (DI 00763000716141), received between Jun 25, 2024 and Sep 30, 2026 — classified as 30 deaths, 290 injuries, 145 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (210 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 465 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50949195 ↗
• InjurySep 28, 2026Intravalvular regurgitation

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50924020 ↗
• MalfunctionSep 24, 2026Material Invagination; Appropriate Device Problem Term/Code Not Available

  It was reported that prior to the implant of a transcatheter aortic bioprosthetic valve, the valve was loaded into the delivery catheter system and upon fluoroscopic inspection of the valve load, frame overlap was observed extending to approximately the fourth node. During initial deployment to 80%, the infold did not resolve and extended to the top of the valve frame. The valve was recaptured and withdrawn from the patient. A replacement valve was loaded, screened, and successfully implanted. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50887528 ↗
• InjurySep 22, 2026Patient Device Interaction Problem

  It was reported that approximately three months following the implant of a transcatheter bioprosthetic valve, a permanent pacemaker was implanted due to complete heart block.

  Patient problems: Heart Block

  MAUDE report 50854356 ↗
• MalfunctionSep 21, 2026Material Invagination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848225 ↗
• MalfunctionSep 21, 2026Material Invagination; Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848029 ↗
• DeathSep 21, 2026Patient Device Interaction Problem

  It was reported that following the implant of a transcatheter aortic valve, the patients blood pressure did not recover. Suicide ventricle, effusion, central regurgitation, paravalvular leak (PVL), coronary occlusion and mitral regurgitation were all ruled out as possible causes for the lack of pressure recovery. Chest compressions were initiated, however the patient ultimately died. Per the physician, possible plaque embolization into the left coronary artery may have been a contributing factor to the death.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 50842659 ↗
• InjurySep 21, 2026Device Dislodged or Dislocated; Activation Failure

  It was reported that during transcatheter aortic valve implantation with the EVFXPLUS-29 transcatheter aortic valve, a pre-implant balloon aortic valvuloplasty (BAV) was performed for calcification. Upon implant of the valve, frame underexpansion was observed, and a post-implant BAV was performed with rapid pacing. During the BAV, the balloon reportedly interacted with the outflow crown and the valve dislodged. Implant depth changed from 3 mm at the non-coronary cusp and left coronary cusp before dislodgement to 0 mm at both cusps after dislodgement. No paravalvular leak, gradient, or central regurgitation was reported. Subsequently, a second Medtronic valve was implanted.

  Patient problems: Foreign Body In Patient

  MAUDE report 50837855 ↗
• InjurySep 17, 2026Patient Device Interaction Problem

  Patient problems: Heart Block

  MAUDE report 50810371 ↗
• DeathSep 14, 2026Difficult or Delayed Positioning; 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 with a non-Medtronic 22 millimeter (mm). Upon the first deployment attempt, the valve was positioned too deep. Subsequently, the valve was recaptured into the delivery catheter system (DCS). Upon the second deployment attempt, the valve was positioned correctly at 80% deployment, however upon turning off the temporary pacing, it was observed that the patient had no blood pressure. The valve was fully deployed, however the patient's blood pressure did not return upon full release. Cardiopulmonary resuscitation (CPR) was initiated, and a transesophageal echocardiogram (TEE) was performed revealing pericardial effusion. The DCS was removed, and pericardiocentesis was performed. Aortogram was performed, revealing acceptable coronary flow and no aortic root injury or annular rupture. The anatomical source of the effusion could not be confirmed, and the patient ultimately died later that day.

  Patient problems: Hemodynamic instability; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 50759844 ↗
• DeathSep 3, 2026Patient Device Interaction Problem

  It was reported that following the implant of a transcatheter aortic valve, while the patient was recovering in the intensive care unit (ICU), the patient's blood pressure suddenly decreased. Resuscitation was attempted, however the patient ultimately died. It was determined that the cause of death was left ventricular tamponade.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 50588286 ↗
• InjuryAug 14, 2026Device Markings/Labelling Problem; 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 50253409 ↗
• MalfunctionAug 6, 2026Material Invagination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50164710 ↗
• InjuryAug 3, 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 50121325 ↗
• InjuryJul 28, 2026Perivalvular Leak; Device Dislodged or Dislocated

  It was reported that, following the implant of the transcatheter aortic valve, paravalvular leak (PVL) of unknown severity occurred. A post-implant balloon aortic valvuloplasty (BAV) was performed while the patient was rapidly paced. Subsequently, the valve dislodged. Prior to valve dislodgement, the implant depth on the non-coronary cusp (NCC) and left coronary cusp (LCC) was 4 millimeter's (mm). After valve dislodgement, the implant depth on the NCC and LCC was -2 mm. The original valve was left in the sinus, and a second valve was implanted valve-in-valve at an implant depth of 6 mm. It was noted that mild PVL was observed post deployment, but a post-implant BAV was not performed. Per the physician, the cause of the dislodgement was due to the post-implant BAV and the depth of implant.

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

  MAUDE report 50060132 ↗
• InjuryJun 23, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 1 YEAR AND 2 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: Insufficient Information

  MAUDE report 25600366 ↗
• InjuryJun 23, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A SECOND VALVE WAS IMPLANTED FOR AN UNSPECIFIED REASON.

  Patient problems: Insufficient Information

  MAUDE report 25596853 ↗
• MalfunctionJun 18, 2026Material Invagination

  IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, DURING THE LOADING CHECK, FRAME NODE OVERLAP TO NODE 3 WAS OBSERVED. A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED DUE TO THE PATIENT'S CALCIFIED ANATOMY. UPON THE FIRST DEPLOYMENT, AT TO 80% DEPLOYMENT IT WAS OBSERVED THAT THE VALVE HAD INFOLDED AT A TARGET IMPLANT DEPTH OF (B)(6)). 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 HIGH CALCIUM BURDEN CONTRIBUTED TO THE INFOLD. A 5-MINUTE PROCEDURAL DELAY OCCURRED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25549505 ↗
• MalfunctionJun 15, 2026Difficult or Delayed Positioning; Material Invagination; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE IMPLANT OF A TRANSCATHETER AORTIC, THE VALVE INFOLDED ON RECAPTURE AND DISLODGED UP INTO THE ASCENDING AORTA. THE DELIVERY SYSTEM AND VALVE WERE RECAPTURED AND REMOVED FROM THE PATIENT AND A NEW VALVE WAS LOADED INTO A NEW DELIVERY SYSTEM AS A REPLACEMENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25511065 ↗
• InjuryJun 11, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 1 DAY FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED FOR COMPLETE HEART BLOCK (CHB).

  Patient problems: Heart Block

  MAUDE report 25473599 ↗
• MalfunctionJun 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 AND SUBSEQUENTLY RECAPTURED DUE TO SUBOPTIMAL POSITIONING. ON THE SECOND DEPLOYMENT ATTEMPT, THE VALVE WAS POSITIONED 3-MILLIMETERS (MM) FROM THE AORTIC ANNULUS. HOWEVER, DURING DEPLOYMENT AN INFOLD WAS NOTED SO THE VALVE WAS RECAPTURED INTO THE DCS. IN RESPONSE, THE DCS WAS REMOVED FROM THE PATIENT'S BODY. A NEW VALVE AND DCS WERE THEN UTILIZED 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25410946 ↗
• InjuryMay 29, 2026Material Invagination; Malposition of Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, AFTER DEPLOYMENT OF THE VALVE, AN INFOLD WAS NOTED. SUBS EQUENTLY, A 23-MILLIMETER (MM) NON-MEDTRONIC BALLOON WAS PREPPED FOR A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV). THE BALLOON WAS THEN PLACED AT THE 29 MM VALVE, AND AS THE POST-IMPLANT BAV WAS BEING COMPLETED, RAPID PACING WAS REDUCED FROM 180 BEATS PER MINUTE (BPM) TO 120 BPM AT REQUEST OF THE ATTENDING PHYSICIAN. AS THE RAPID PACING WAS DECREASED, THE BALLOON WAS NOT FULLY INFLATED, CAUSING THE VALVE TO EMBOLIZE INTO THE DESCENDING AORTA. SUBSEQUENTLY, A NEW 29 MM VALVE WAS PREPARED AND SUCCESSFULLY IMPLANTED. A 1-HOUR PROCEDURAL DELAY OCCURRED DUE TO THE VALVE INFOLD AND DISLODGE. PER THE PHYSICIAN, THE EARLY TERMINATION OF THE RAPID PACING AND LATE INFLATION OF THE POST-IMPLANT BAV CONTRIBUTED TO THE VALVE DISLODGE. ADDITIONALLY, THE PHYSICIAN REPORTED THAT THE PROCEDURE CONTRIBUTED TO THE VALVE INFOLD AND DISLODGE.

  Patient problems: Foreign Body In Patient

  MAUDE report 25331158 ↗
• MalfunctionMay 20, 2026Material Invagination

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS COM PLETED DUE TO IT BEING STANDARD FOR THE IMPLANTING PHYSICIAN AND CALCIFICATION. 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 3 MILLIMETERS (MM) FROM THE NON-CORONARY CUSP (NCC) AND 4 MM FROM THE LEFT CORONARY CUSP (LCC). AS THE VALVE WAS BEING DEPLOYED, AN INFOLD WAS NOTED. SUBSEQUENTLY, THE VALVE WAS RECAPTURED AND REMOVED FROM THE PATIENT. A NEW VALVE WAS 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 25234267 ↗
• InjuryMay 19, 2026Device Dislodged or Dislocated; Intravalvular regurgitation

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, IN A PATIENT WITH A PREVIOUSLY IMPLANTED MEDTRONIC SURGICAL VALVE, THE DELIVERY CATHETER SYSTEM (DCS) WAS INSERTED INTO THE PATIENT AND ADVANCED TO THE AORTIC ANNULUS. THE VALVE WAS THEN IMPLANTED IN THAT IT WAS POSITIONED 4 TO 5 MILLIMETERS (MM) FROM THE NCC AND 4 TO 5 MM FROM THE LEFT CORONARY CUSP (LCC). AN INITIAL ECHOCARDIOGRAM WAS THEN OBTAINED, WHICH REVEALED THAT SEVERE CENTRAL AORTIC VALVE REGURGITATION WAS PRESENT. SUBSEQUENTLY, THE GUIDEWIRE AND PIGTAIL WERE REMOVED FROM THE NCC. ANOTHER ECHOCARDIOGRAM WAS THEN OBTAINED, WHICH REVEALED THAT THE VALVE HAD MOVED 1 TO 2 MM TOWARDS THE PATIENT'S AORTA IN RELATION TO BOTH THE NCC AND LCC. SUBSEQUENTLY, THE ATTENDING PHYSICIAN DECIDED TO IMPLANT A SECOND NON-MEDTRONIC 26 MM TRANSCATHETER VALVE BETWEEN NODE 3 AND NODE 4 OF THE PREVIOUSLY IMPLANTED VALVE. AFTER IMPLANTATION OF THE SECOND VALVE, NO REGURGITATION WAS IDENTIFIED AND THE PROCEDURE WAS COMPLETED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 25220927 ↗
• MalfunctionMay 18, 2026Material Invagination; Activation Failure

  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 THEN DEPLOYED BUT SUBSEQUENTLY RECAPTURED DUE TO SUB-OPTIMAL POSITIONING AND VALVE UNDER EXPANSION. THE VALVE WAS THEN REPOSITIONED IN THAT IT WAS 4-MILLIMETERS (MM) FROM THE NON-CORONARY CUSP (NCC) AND 5 MM FROM THE LEFT CORONARY CUSP (LCC). THE VALVE WAS THEN DEPLOYED FOR A SECOND TIME, HOWEVER, DURING THE SECOND DEPLOYMENT ATTEMPT AN INFOLD WAS NOTED. SUBSEQUENTLY, THE VALVE WAS RECAPTURED AND REMOVED FROM THE PATIENT'S BODY. A BALLOON AORTIC VALVULOPLASTY WAS THEN COMPLETED WITH A NON-MEDTRONIC BALLOON. A NEW DCS WAS THEN UTILIZED TO SUCCESSFULLY IMPLANT A NEW VALVE. 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 25205591 ↗

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, 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-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