Evolut™ FX D-EVOLUTFX-34 (UDI 00763000942717)Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00763000942717), received between Jun 27, 2025 and Sep 17, 2026 — classified as 18 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (18 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Device Dislodged or Dislocated; Patient Device Interaction Problem

  Patient problems: Aortic dissection

  MAUDE report 50808552 ↗
• MalfunctionAug 27, 2026Difficult or Delayed Positioning; Device Dislodged or Dislocated

  It was reported that during the attempted implant of a 29 millimeter (mm) transcatheter aortic valve, the valve would not stay in place. After 4 deployment attempts and recaptures it was decided to size up. The valve was replaced with a larger 34 mm valve. The 34 mm valve was loaded into a new delivery catheter system (DCS), and the valve held in place after 2 attempts. Per the physician, the patient's anatomy and valve size contributed to the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50476718 ↗
• MalfunctionJun 18, 2026Material Invagination; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE, THE VALVE DISLODGED AT APPROXIMATELY 80% DEPLOYMENT WHEN IT WAS DESCRIBED AS WELL EXPANDED WITH NO SIGN OF INFOLDING. THE VALVE WAS RECAPTURED, AND UPON RECAPTURE IT APPEARED THAT VALVE INFOLDING HAD OCCURRED. ON A SECOND DEPLOYMENT ATTEMPT, THE VALVE INFOLDED AGAIN, AND THE VALVE WAS RECAPTURED AND REMOVED FROM THE PATIENT. A NEW VALVE WAS THEN LOADED AND DEPLOYED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25547333 ↗
• MalfunctionMay 28, 2026Material Separation; Failure to Advance

  IT WAS REPORTED THAT PRIOR TO THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED WITH A NON-MEDTRONIC 26 MILLIMETER (MM) BALLOON. FOLLOWING INSERTION OF THE DELIVERY CATHETER SYSTEM (DCS) INTO THE PATIENT, WHILE ATTEMPTING TO CROSS THE NATIVE VALVE, THE NOSE CONE BUCKLED. AN ADDITIONAL ATTEMPT WAS MADE TO CROSS THE NATIVE VALVE, HOWEVER THE DCS WAS UNABLE TO ADVANCE FURTHER. SUBSEQUENTLY, THE SYSTEM WAS WITHDRAWN FROM THE PATIENT, AND A SECOND VALVE AND DCS WERE OPENED. A SNARE WAS UTILIZED TO GUIDE THE SECOND DCS, AND THE VALVE WAS SUCCESSFULLY IMPLANTED. PER THE PHYSICIAN, THE PATIENT'S CALCIFICATION AND BICUSPID NATIVE VALVE CONTRIBUTED TO THE ADVANCEMENT DIFFICULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25321636 ↗
• MalfunctionApr 29, 2026Device Dislodged or Dislocated

  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. THE DCS WAS THEN INSERTED INTO THE PATIENT, AND THE VALVE WAS ADVANCED TO THE AORTIC ANNULUS. THE VALVE WAS THEN PARTIALLY DEPLOYED BUT SUBSEQUENTLY RECAPTURED. WHILE RECAPTURING THE VALVE, AN INFOLD WAS NOTED SO THE VALVE WAS WITHDRAWN FROM THE PATIENT'S BODY. A NEW DCS AND VALVE WERE THEN PREPARED AND INSERTED INTO THE PATIENT'S BODY. THE VALVE WAS THEN DEPLOYED AT THE AORTIC ANNULUS BUT SUBSEQUENTLY WAS RECAPTURED. UPON SECOND DEPLOYMENT, AN INFOLD WAS NOTED SO THE VALVE WAS RECAPTURED AND WITHDRAWN FROM THE PATIENT'S BODY. A THIRD VALVE WAS THEN PREPARED ALONG WITH A NEW DCS. THE DCS WAS THEN INSERTED INTO THE PATIENT'S BODY AND VALVE WAS SUCCESSFULLY IMPLANTED. A 20-MINUTE PROCEDURAL DELAY OCCURRED DUE TO THE VALVE INFOLDS. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO ISSUE DURING THE LOADING OF BOTH VALVES. THE FIRST VALVE WAS RECAPTURED BECAUSE THE VALVE DISLODGED INTO THE SINUS WHILE ATTACHED TO THE DCS AT 80% DEPLOYMENT. THE SECOND VALVE WAS RECAPTURED BECAUSE THE VALVE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035147 ↗
• MalfunctionApr 22, 2026Device Dislodged or Dislocated

  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 NATIVE BICUSPID VALVE. UPON DEPLOYMENT OF THE VALVE, THE VALVE REPEATEDLY DISLODGED WHILE ATTACHED TO THE DELIVERY CATHETER SYSTEM (DCS). SUBSEQUENTLY, THE VALVE WAS RECAPTURED INTO THE DCS, AND THE SYSTEM WAS WITHDRAWN FROM THE PATIENT. THE PROCEDURE WAS ABORTED, AND THE PATIENT IS BEING WORKED UP FOR A POTENTIAL SURGICAL AORTIC VALVE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957997 ↗
• MalfunctionApr 17, 2026Material Invagination; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED. ON THE FIRST DEPLOYMENT ATTEMPT, AN INFOLD OF THE VALVE WAS OBSERVED AT A TARGET IMPLANT DEPTH OF 3 MILLIMETERS (MM). SUBSEQUENTLY, THE VALVE DISLODGED WHILE STILL ATTACHED TO THE DELIVERY CATHETER SYSTEM (DCS). IT WAS OBSERVED THAT FOLLOWING THE DISLODGEMENT, THE INFOLD HAD RESOLVED. SUBSEQUENTLY, THE VALVE WAS RECAPTURED INTO THE DCS, AND ON THE SECOND DEPLOYMENT ATTEMPT, THE VALVE WAS IMPLANTED SUCCESSFULLY. 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 24912399 ↗
• MalfunctionApr 7, 2026Difficult or Delayed Positioning; Device Dislodged or Dislocated; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, TWO PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY'S WERE COMPLETED WITH A 26-MILLIMETER (MM) NON-MEDTRONIC BALLOON DUE TO THE PATIENT HAVING A BICUSPID AORTIC VALVE. IT WAS NOTED THAT DURING BOTH DILATIONS, COMPLETE EXPANSION DID NOT OCCUR. THE DELIVERY CATHETER SYSTEM (DCS) AND MEDTRONIC (STEDI) GUIDEWIRE WERE THEN ADVANCED THROUGH THE PATIENT'S ANATOMY. ONCE AT THE AORTIC ANNULUS, THERE WAS SIGNIFICANT DIFFICULTY ADVANCING THE DCS AND GUIDEWIRE OVER THE AORTIC ANNULUS. IT WAS NOTED THAT THE MEDTRONIC GUIDEWIRE CURVATURE APPEARED TO LOSE ITS SHAPE. EVENTUALLY, THE DCS WAS ABLE TO BE ADVANCED OVER THE ANNULUS AND WAS POSITIONED IN THAT IT WAS 0 MM FROM THE NON-CORONARY CUSP (NCC). THE VALVE WAS THEN DEPLOYED TO 80%, WHERE IT WAS THEN NOTED THAT THE VALVE WAS POSITIONED TOO DEEP IN RELATION TO THE AORTIC ANNULUS. SUBSEQUENTLY, THE VALVE WAS RECAPTURED AND REDEPLOYED AT A TARGET IMPLANT DEPTH OF 3 MM. DURING DEPLOYMENT IT WAS NOTED THAT AN INFOLD HAD OCCURRED. SUBSEQUENTLY, THE VALVE WAS RECAPTURED AND WITHDRAWN FROM THE PATIENT'S BODY. A NEW VALVE, DCS, AND NON-MEDTRONIC GUIDEWIRE WERE PREPARED. THE DCS WAS THEN

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 24810401 ↗
• MalfunctionApr 3, 2026Particulates; Contamination /Decontamination Problem

  IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, DURING LOADING, BLOOD WAS FOUND IN THE FLUSH PORT OF THE DELIVERY CATHETER SYSTEM (DCS). SUBSEQUENTLY, A NEW VALVE, DCS AND COMPRESSION LOADING SYSTEM (CLS) WERE OPENED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24778936 ↗
• InjuryMar 26, 2026Failure to Advance; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING AN ATTEMPTED TRANSCATHETER AORTIC VALVE PROCEDURE USING THE EVOLUT FX DELIVERY CATHETER SYSTEM (DCS), THE DCS WAS UNABLE TO BE TRACKED THROUGH THE PATIENT¿S FEMORAL ARTERY DESPITE USE OF SHOCKWAVE AND SEQUENTIAL ARTERIAL DILATION. THE PATIENT EXPERIENCED A FEMORAL ARTERY INJURY THAT REQUIRED BALLOONING OF THE FEMORAL ARTERIES AND PLACEMENT OF TWO COVERED STENTS, AND THE PATIENT RECEIVED A TRANSFUSION OF 2 UNITS OF BLOOD. THE VALVE WAS NOT IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED THAT RIGHT FEMORAL ARTERY ACCESS WAS USED FOR THE DCS AND THE MINIMUM DIAMETER OF THE ACCESS VESSEL WAS 6.0 MM. THE INJURY OCCURRED WHEN ADVANCING THE DCS THROUGH THE RIGHT FEMORAL ARTERY DUE TO TRAUMA CAUSING A HEMATOMA AND PERFORATION. PER THE PHYSICIAN, THE CAUSE OF THE INJURY WAS TRAUMA TO THE FEMORAL ARTERY WHICH WAS POSSIBLY CAUSED BY THE DCS. THE PATIENT HAD BILATERAL ILIAC AND COMMON FEMORAL STENTS AND HEAVILY CALCIFIED FEMORAL ARTERIES WHICH CONTRIBUTED TO THE INJURY.

  Patient problems: Hematoma; Perforation of Vessels; Unspecified Vascular Problem

  MAUDE report 24701329 ↗
• MalfunctionMar 23, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE, SEVERAL DEPLOYMENT ATTEMPTS WERE MADE, HOWEVER THE VALVE REPEATEDLY DISLODGED AORTIC WHILE STILL ATTACHED TO THE DCS. SUBSEQUENTLY, THE SYSTEM WAS WITHDRAWN FROM THE PATIENT, AND IT WAS DECIDED TO ABORT THE PROCEDURE TO RE-EVALUATE FOR ALTERNATIVE TREATMENT OPTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664450 ↗
• MalfunctionMar 18, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED DUE TO THE PATIENT'S PRE-EXISTING CALCIFICATION. UPON THE FIRST DEPLOYMENT ATTEMPT, IT WAS OBSERVED THAT THE VALVE DISLODGED WHILE STILL ATTACHED TO THE DELIVERY CATHETER SYSTEM (DCS) AS THE POSITIONING WAS TOO HIGH RELATIVE TO THE TARGET IMPLANT DEPTH OF 3-5 MILLIMETERS (MM), SO A RECAPTURE WAS NECESSARY. FOLLOWING RECAPTURE, AN INFOLD OF THE VALVE WAS OBSERVED. SUBSEQUENTLY, THE SYSTEM WAS WITHDRAWN FROM THE PATIENT, AND A NEW VALVE AND DCS WERE LOADED. IT WAS NOTED THAT THE PHYSICIAN DECIDED TO SWITCH FROM ONE NON-MEDTRONIC GUIDEWIRE TO ANOTHER NON-MEDTRONIC GUIDEWIRE FOR THE SECOND SYSTEM. UPON THE FIRST DEPLOYMENT ATTEMPT WITH THE NEW SYSTEM, THE POSITIONING OF THE VALVE WAS UNACCEPTABLE RELATIVE TO THE TARGET IMPLANT DEPTH, AND A RECAPTURE WAS SUBSEQUENTLY PERFORMED. UPON THE SECOND DEPLOYMENT ATTEMPT, THE PHYSICIAN DECIDED TO SWITCH BACK TO THE INITIAL NON-MEDTRONIC GUIDEWIRE, SO THE SYSTEM WAS WITHDRAWN FROM THE PATIENT. SUBSEQUENTLY, A THIRD VALVE WAS LOADED INTO A THIRD DCS, AND THE VALVE WAS PLACED SUCCESSFULLY. PER THE PHYSICIAN,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626858 ↗
• MalfunctionMar 17, 2026Packaging Problem

  IT WAS REPORTED THAT PRIOR TO THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE, IT WAS OBSERVED THAT THE OUTER BOX OF THE DELIVERY CATHETER SYSTEM (DCS) PACKAGING WAS DAMAGED. HOLES WERE OBSERVED IN THE STERILE WRAPPING, AND MOLD WAS SEEN OUTSIDE OF THE STERILE PACKAGING. SUBSEQUENTLY, A NEW DCS WAS OPENED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619689 ↗
• InjuryMar 6, 2026Patient 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 IT BEING STANDARD FOR THE IMPLANTING PHYSICIAN. THE DELIVERY CATHETER SYSTEM (DCS) WAS THEN INSERTED INTO THE PATIENT AND ADVANCED TO THE AORTIC ANNULUS. UPON 80-100% DEPLOYMENT OF THE 29-MILLIMETER (MM) VALVE, THE VALVE DISLODGED TOWARDS THE PATIENT'S VENTRICLE. SUBSEQUENTLY, THE VALVE WAS ABANDONED AND THE DCS WAS WITHDRAWN FROM THE PATIENT. A SECOND 34 MM VALVE WAS THEN PREPARED AND LOADED INTO A NEW DCS. ULTIMATELY, THE ATTEMPTED IMPLANT OF THE 34 MM VALVE WAS UNSUCCESSFUL. DURING THE PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED WITH A POTENTIAL "FLAP" VIA ECHOCARDIOGRAM. THE PATIENT WAS INTUBATED AND THE PROCEDURE WAS ABORTED. A 4-HOUR PROCEDURAL DELAY OCCURRED DUE TO THE VALVE DISLODGE AND PERICARDIAL EFFUSION.

  Patient problems: Pericardial Effusion

  MAUDE report 24537372 ↗
• InjuryFeb 16, 2026Difficult or Delayed Positioning; Device-Device Incompatibility; Difficult to Open or Close; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPERIENCED A STROKE AND LOST THEIR VISION.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Loss of Vision; Low Blood Pressure/ Hypotension; Stroke/CVA

  MAUDE report 24344482 ↗
• InjuryFeb 9, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING THE FIRST DEPLOYMENT ATTEMPT OF A TRANSCATHETER VALVE, AT A DEPTH OF 3 MM ON THE NON-CORONARY CUSP AND 10 MM ON THE LEFT CORONARY CUSP, COMPLETE HEART BLOCK (CHB) OCCURRED. A SECOND AND THIRD DEPLOYMENT ATTEMPT WERE PERFORMED TO RESOLVE THE CHB AND THE VALVE WAS IMPLANTED; HOWEVER, THE CHB CONTINUED FOLLOWING THE IMPLANT OF THE VALVE. SUBSEQUENTLY, A PERMANENT PACEMAKER WAS IMPLANTED TWO DAYS AFTER THE VALVE IMPLANT.

  Patient problems: Heart Block

  MAUDE report 24298593 ↗
• MalfunctionJan 8, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER VALVE, THE DEPLOYMENT OF THE VALVE WAS ATTEMPTED FOUR TIMES AS THE VALVE WOULD NOT SEAT AT AN APPROPRIATE DEPTH. SUBSEQUENTLY, THE VALVE WAS WITHDRAWN FROM THE PATIENT, AND NO FURTHER INTERVENTION WAS PERFORMED. PER THE PHYSICIAN, THE PATIENT'S PRE-EXISTING SEVERE AORTIC REGURGITATION CONTRIBUTED TO THE DISLODGE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24010493 ↗
• MalfunctionDec 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER VALVE, THE VALVE DID NOT FIXATE TO THE ANNULUS. SUBSEQUENTLY, THE VALVE WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865361 ↗
• MalfunctionDec 22, 2025Device Dislodged or Dislocated; Patient Device Interaction Problem; Device Dislodged or Dislocated; Patient Device Interaction Problem

  IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WHICH WAS STANDARD FOR THE IMPLANTING PHYSICIAN. UPON THE FIRST DEPLOYMENT ATTEMPT, A PREMATURE VENTRICULAR CONTRACTION (PVC) OCCURRED AND THE VALVE DISLODGED AORTIC. SUBSEQUENTLY, THE VALVE WAS RECAPTURED; HOWEVER, AN INFOLD WAS OBSERVED DURING RECAPTURE. THE SYSTEM WAS WITHDRAWN FROM THE PATIENT AND NEW VALVE AND NEW DELIVERY CATHETER SYSTEM (DCS) WERE USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN ATTRIBUTED THE INFOLD TO HOW THE INFLOW MADE CONTACT WITH THE OUTER CURVE OF THE AORTA AND THE RECAPTURE PROCESS HAD ALREADY STARTED ALLOWING THE VALVE TO FOLD.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23861422 ↗
• InjuryDec 5, 2025Difficult or Delayed Positioning; Patient Device Interaction Problem; Difficult or Delayed Positioning; Patient Device Interaction Problem

  IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER VALVE, THE PATIENT HAD A LOW EJECTION FRACTION (EF) OF 30%, OCCLUDED LEFT MAIN ARTERY, AND MULTIPLE PREVIOUSLY IMPLANTED STENT GRAFTS. A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED USING A 25 MILLIMETER (MM) NON-MEDTRONIC BALLOON. THE DEPLOYMENT OF THE VALVE WAS ATTEMPTED TWO TIMES WHILE THE PATIENT WAS RAPIDLY PACED, AND RECAPTURED FOLLOWING EACH ATTEMPT DUE TO A DEEP IMPLANT DEPTH ON THE LEFT CORONARY CUSP (LCC). FOLLOWING THE SECOND RECAPTURE, THE PATIENT BECAME HYPOTENSIVE. SUBSEQUENTLY, CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED, AND ADVANCED CARDIOVASCULAR LIFE SUPPORT (ACLS) MEDICATION WAS ADMINISTERED. VENTRICULAR FIBRILLATION OCCURRED AND DEFIBRILLATION WAS REQUIRED. THE PHYSICIAN DECIDED TO IMPLANT THE TRANSCATHETER VALVE, AND THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) FOLLOWING IMPLANTATION. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED THAT SHOWED THE VALVE WAS IN GOOD POSITION, A SINGLE DIGIT MEAN GRADIENT, AND NO AORTIC INSUFFICIENCY; HOWEVER, A LOW EF OF APPROXIMATELY 10% WAS NOTED. ADDITIONALLY, THERE WAS NO EVIDENCE OF ANNULAR RUPTURE OR AORTIC DISS

  Patient problems: Low Blood Pressure/ Hypotension; Ventricular Fibrillation

  MAUDE report 23732605 ↗
• InjuryDec 2, 2025Failure to Advance; Patient Device Interaction Problem; Failure to Advance; Patient Device Interaction Problem

  IT WAS REPORTED THAT PRIOR TO THE ATTEMPTED IMPLANT OF A TRANSCATHETER VALVE, THE 18 FRENCH (FR) NON-MEDTRONIC SHEATH WAS DIFFICULT TO ADVANCE. SUBSEQUENTLY, A SHOCKWAVE PROCEDURE WAS PERFORMED WITH A 12 MILLIMETER (MM) BALLOON, AND THE 18 FR SHEATH WAS ADVANCED. THE VALVE WAS CROSSED AND A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED DUE TO CALCIFICATION. HOWEVER, DURING DELIVERY CATHETER SYSTEM (DCS) ADVANCEMENT, THE DCS WAS UNABLE TO ADVANCE THROUGH THE LEFT COMMON ILIAC ARTERY. SUBSEQUENTLY, THE PROCEDURE WAS ABORTED, AND THE PATIENT WAS TRANSFERRED TO SURGERY DUE TO AN ILIAC DISSECTION. PER THE PHYSICIAN, THE PATIENT'S CALCIFIED ANATOMY CONTRIBUTED TO THE EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 23696371 ↗
• MalfunctionNov 26, 2025Particulates; Appropriate Device Problem Term/Code Not Available; Particulates; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION WAS RECEIVED THAT A HAIR WAS PRESENT AFTER OPENING THE DCS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659555 ↗
• InjuryNov 20, 2025Fluid/Blood Leak; Device Dislodged or Dislocated; Fluid/Blood Leak; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED THAT CLARIFIED THAT PVL DID NOT OCCUR FOLLOWING THE DISLODGEMENT OF THE SECOND VALVE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions; Valvular Insufficiency/ Regurgitation

  MAUDE report 23610293 ↗
• InjuryNov 13, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON THE SAME DAY AS THE IMPLANT OF A TRANSCATHETER VALVE, A POSTERIOR PERITONEAL HEMORRHAGE WAS OBSERVED AFTER THE PROCEDURE WAS COMPLETED. MEDICATION WAS PROVIDED TO TREAT THE ISSUE. ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE PERITONEAL HEMORRHAGE IS UNKNOWN, AND IT IS ALSO UNKNOWN IF A MEDTRONIC DEVICE WAS A CAUSAL FACTOR.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23543121 ↗
• InjuryNov 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER VALVE, UPON THE FIRST DEPLOYMENT ATTEMPT, THE VALVE WAS RECAPTURED DUE TO THE IMPLANT DEPTH BEING TOO HIGH. UPON RECAPTURE, AN INFOLD WAS OBSERVED. A SECOND DEPLOYMENT ATTEMPT WAS PERFORMED, AND THE INFOLD WAS STILL PRESENT. IT WAS NOTED THAT THE TARGET IMPLANT DEPTH WHEN THE INFOLD OCCURRED WAS 2 MILLIMETERS (MM). SUBSEQUENTLY, THE VALVE WAS RECAPTURED AND WITHDRAWN FROM THE PATIENT, AND A NEW TRANSCATHETER VALVE AND NEW DELIVERY CATHETER SYSTEM (DCS) WERE USED. UPON DEPLOYMENT OF THE NEW VALVE, THE IMPLANT DEPTH WAS 3 MM ON THE NON-CORONARY CUSP (NCC) AND 3 MM ON THE LEFT CORONARY CUSP (LCC). SUBSEQUENTLY, THE VALVE WAS FULLY DEPLOYED; HOWEVER, "SOME" PARAVALVULAR LEAK (PVL) WAS NOTED. A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED USING A 26 MM NON-MEDTRONIC BALLOON WHILE THE PATIENT WAS RAPIDLY PACED OFF THE MEDTRONIC GUIDEWIRE AS VENOUS ACCESS WAS UNABLE TO BE OBTAINED. DURING THE POST-IMPLANT BAV, PREMATURE VENTRICULAR CONTRACTION (PVC) WAS OBSERVED, AND THE VALVE DISLODGED AORTIC BEFORE THE BALLOON WAS DOWN. SUBSEQUENTLY, THE VALVE WAS SNARED IN PLACE ABOVE THE SINOTUBULAR JUN CTION (STJ) W

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23512918 ↗

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-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-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