EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV)Recalls & reported problems across all models

We found 3 models of EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 168 adverse event reports in the FDA's MAUDE database, received between Feb 5, 2021 and Jun 22, 2026 — classified as 3 deaths, 165 injuries.

The most frequently reported specific device problem is “Degraded” (66 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) problems

EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) 9300TFX

  Aortic valve, prosthesis, percutaneously delivered
  1 death68 reports
• EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) 9300TFX

  Aortic valve, prosthesis, percutaneously delivered
  1 death64 reports
• EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) 9300TFX

  Aortic valve, prosthesis, percutaneously delivered
  1 death36 reports

Recent EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2026Device Stenosis

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, APPROXIMATELY 10 YEARS AND 6 MONTHS POST IMPLANTATION OF A 26MM SAPIEN XT VALVE IN A ON EDWARDS SURGICAL VALVE IN THE TRICUSPID POSITION, A VALVE IN VALVE WITH 23MM SAPIEN 3 ULTRA RESILIA VALVE WAS PERFORMED DUE TO STENOSIS. PATIENT SYMPTOMS NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25580972 ↗
• InjuryMay 26, 2026Insufficient Device Problem Information

  AS REPORTED BY IMPLANT PATIENT REGISTRY THROUGH RECEIPT OF AN IMPLANT DATA CARD, APPROXIMATELY 9 YEARS AND 7 MONTHS POST TRANSFEMORAL TRANSCATHETER VALVE REPLACEMENT PROCEDURE WITH A 23 MM SAPIEN XT VALVE IN THE PULMONIC POSITION, THE PATIENT'S VALVE WAS EXPLANTED AND REPLACED WITH A SURGICAL VALVE. THE CAUSE OF THE EXPLANT IS UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 25280507 ↗
• DeathApr 24, 2026Device Stenosis

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT A 26MM SAPIEN XT VALVE, IMPLANTED IN THE AORTIC POSITION, IS FAILING AFTER AN IMPLANT DURATION OF 10 YEARS AND 11 MONTHS DUE TO STENOSIS. A VALVE IN VALVE PROCEDURE WAS SCHEDULED. THROUGH FOLLOW UP WITH THE VALVE CLINIC COORDINATOR, IT WAS REPORTED THAT THE PATIENT PASSED AWAY PRIOR TO THE VALVE IN VALVE PROCEDURE. THE PATIENT'S VALVE WAS STENOTIC AND THE PATIENT HAD SYMPTOMS OF FATIGUE AND EDEMA. THE PATIENTS CO-MORBIDITIES INCLUDED NONALCOHOLIC STEATOHEPATITIS (NASH), DIABETES MELLITUS (DM), ANEMIA AND CHRONIC RESPIRATORY FAILURE. THE PATIENT'S RECENT ECHO SHOWED A LEFT VENTRICULAR EJECTION FRACTION (LVEF) OF 65-70%, MODERATE AORTIC STENOSIS S/P TAVR, MODERATE TRICUSPID REGURGITATION, MILD-MODERATE MITRAL REGURGITATION, MODERATE-SEVERE MITRAL ANNULAR CALCIFICATION, AND NO MITRAL STENOSIS.

  Patient problems: Dyspnea; Fatigue

  MAUDE report 24988784 ↗
• InjuryApr 13, 2026Degraded

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY TEN YEARS AND NINE MONTHS FOLLOWING A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE WITH A 26MM SAPIEN XT VALVE, THE PATIENT PRESENTED WITH DYSPNEA. ECHOCARDIOGRAPHY DEMONSTRATED MIXED AORTIC STENOSIS AND A MILD CENTRAL LEAK. THE PATIENT SUBSEQUENTLY UNDERWENT A SUCCESSFUL VALVE-IN-VALVE PROCEDURE USING A 20MM SAPIEN 3 ULTRA RESILIA VALVE. THE PATIENT WAS REPORTED TO BE STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Dyspnea

  MAUDE report 24866957 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY IMPLANT PATIENT REGISTRY, THE PATIENT HAD A SUCCESSFUL TAVR PROCEDURE USING A 26MM SAPIEN XT VALVE IN THE AORTIC POSITION. DURING THE PROCEDURE THE PATIENT DEVELOPED A TRANSIENT AV BLOCK. WHILE THE HEART BLOCK RESOLVED WITH A RETURN OF NORMAL QRS DIMENSION, THE BLOCK NECESSITATED THE NEED FOR INSERTION OF A NEW TEMPORARY PACEMAKER. DUE TO CHALLENGES FACED DURING TEMPORARY PACEMAKER LEAD PLACEMENT, BOTH THE LEFT GROIN VEIN AND THE RIGHT AXILLARY SUBCLAVIAN VEIN ACCESSES WERE UTILIZED.

  Patient problems: Heart Block

  MAUDE report 24590419 ↗
• InjuryJan 19, 2026Fluid/Blood Leak

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, APPROXIMATELY 7 YEARS POST IMPLANTATION OF A 23MM SAPIEN XT VALVE IN THE PULMONIC POSITION, A VALVE IN VALVE WITH A 23MM SAPIEN 3 VALVE WAS PERFORMED DUE TO CENTRAL PULMONIC REGURGITATION. PATIENT SYMPTOMS NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24111412 ↗
• InjuryDec 22, 2025Device Stenosis; Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY (B)(6) POST TRANSFEMORAL TMVR (TRANSCATHETER MITRAL VALVE REPLACEMENT) PROCEDURE WITH A 26MM SAPIEN XT VALVE IN THE NATIVE MITRAL POSITION, THE VALVE FAILED DUE TO STENOSIS. PER REPORT, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE PATIENT UNDERWENT A SUCCESSFUL VALVE-IN-VALVE PROCEDURE WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Dyspnea

  MAUDE report 23872718 ↗
• InjuryDec 2, 2025Degraded; Perivalvular Leak; Degraded; Perivalvular Leak

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT A PATIENT WITH A 29MM SAPIEN XT VALVE, IMPLANTED IN THE TRICUSPID POSITION, UNDERWENT A TRANSSEPTAL VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 10 YEARS AND 1 MONTH DUE TO PVL. A 26MM SAPIEN 3 ULTRA RESILIA VALVE WAS IMPLANTED SUCCESSFULLY. THE PATIENT WAS AN ADULT CONGENITAL ANATOMY WITH PRIOR SURGICAL REPAIR.

  Patient problems: Insufficient Information

  MAUDE report 23694750 ↗
• InjuryNov 25, 2025Degraded; Device Stenosis; Unspecified Valve Regurgitation; Degraded; Device Stenosis; Unspecified Valve Regurgitation

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 9 YEARS AND 1 MONTH POST TRANSFEMORAL TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 29MM SAPIEN XT VALVE, THE VALVE FAILED DUE TO AORTIC STENOSIS (AS) AND AORTIC INSUFFICIENCY (AI). THE PATIENT UNDERWENT A SUCCESSFUL VALVE-IN-VALVE PROCEDURE WITH A 29MM SAPIEN 3 ULTRA RESILIA VALVE.

  Patient problems: Insufficient Information

  MAUDE report 23649763 ↗
• InjuryNov 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY AN EDWARDS LIFESCIENCES AFFILIATE, APPROXIMATELY 7 YEARS AND 3 MONTHS POST IMPLANTATION OF A 23MM SAPIEN XT VALVE IN THE PULMONIC POSITION, A VALVE IN VALVE WAS PERFORMED WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE DUE TO MODERATE PULMONIC VALVE REGURGITATION, MEAN GRADIENT IS 20MMHG W/MILD PS. PATIENT SYMPTOMS: WORSENING RV DILATION VIA MRI.

  Patient problems: Insufficient Information

  MAUDE report 23469436 ↗
• DeathNov 4, 2025Malposition of Device; Device Stenosis; Malposition of Device; Device Stenosis

  AS REPORTED BY IMPLANT PATIENT REGISTRY, A PATIENT PASSED AWAY APPROXIMATELY 5 YEARS AND 9 MONTHS POST TAVR. MEDICAL RECORDS WERE RECEIVED FROM THE HOSPITAL. AFTER A REVIEW OF MEDICAL RECORDS PROVIDED, IT WAS CONFIRMED THAT THE PATIENT WAS AN 80-YEAR-OLD FEMALE WITH A PAST MEDICAL HISTORY OF AORTIC STENOSIS (AS), ACUTE ON CHRONIC DIASTOLIC HEART FAILURE, CORONARY ARTERY DISEASE (CAD), NON-ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI), AND ACUTE HYPOXIC RESPIRATORY FAILURE, WHO UNDERWENT A SUCCESSFUL IMPLANTATION OF A 23MM EDWARDS XT VALVE IN THE AORTIC POSITION ON (B)(6) 2015. APPROXIMATELY 5 YEARS AND 9 MONTHS POST-IMPLANTATION, THE EDWARDS IMPLANT PATIENT REGISTRY RECEIVED NOTIFICATION OF THE PATIENT'S DEATH. RECORDS INDICATE THE PATIENT WAS ADMITTED ON (B)(6) 2025 WITH SHORTNESS OF BREATH AND TREATED WITH DIURETICS FOR ACUTE ON CHRONIC DIASTOLIC HEART FAILURE. ON (B)(6) 2025, THE PATIENT WAS FOUND UNRESPONSIVE WITHOUT A PULSE. ADVANCED CARDIAC LIFE SUPPORT (ACLS) WAS INITIATED AND RETURN OF SPONTANEOUS CIRCULATION (ROSC) WAS ACHIEVED AFTER APPROXIMATELY 6 MINUTES. THE PATIENT WAS INTUBATED AND TRANSFERRED TO THE ICU. ON (B)(6) 2025, THE PATIENT EXPERIENCED BRADYCARDIA AND LATER A

  Patient problems: Cardiac Arrest

  MAUDE report 23468300 ↗
• InjuryOct 23, 2025Degraded; Degraded

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, A PATIENT UNDERWENT A TRANSFEMORAL TAVR PROCEDURE WITH A 29MM SAPIEN XT VALVE IN AORTIC POSITION. APPROXIMATELY 10 YEARS AND 3 MONTHS LATER, THE PATIENT UNDERWENT A VALVE IN VALVE WITH A 26MM SAPIEN 3 ULTRA RESILIA VALVE INSIDE THE PRE-EXISTING 29MM SAPIEN XT VALVE DUE TO STENOSIS AND NEW ONSET ACUTE AORTIC INSUFFICIENCY (AI). THE CARDIOLOGIST NOTED THAT A PIECE OF THE FAILED VALVE LEAFLET PROLAPSING COULD BE VISUALIZED ON TEE. PATIENT REMAINED IN STABLE CONDITION AND THE AI HAS RESOLVED AND DIASTOLIC PRESSURES ARE BETTER.

  Patient problems: Insufficient Information

  MAUDE report 23374246 ↗
• InjuryOct 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, 10 YEARS AND 8.5 MONTHS FOLLOWING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE WITH A 26MM SAPIEN XT VALVE IMPLANTED WITHIN A THV IMPLANTED WITHIN A HOMOGRAFT, THE PATIENT WAS FOUND TO HAVE 3 TO 4+ CENTRAL AORTIC INSUFFICIENCY AND WILL MOST LIKELY BE TREATED WITH A SURGICAL EXPLANT. AFTER REVIEWING THE MEDICAL RECORDS PROVIDED, THE PATIENT IS A 63-YEAR-OLD MALE, WITH A HISTORY OF AORTIC ROOT HOMOGRAFT, HOMOGRAFT VALVE STENOSIS, HEART FAILURE WITH PRESERVED EJECTION FRACTION, NON-OBSTRUCTIVE CORONARY ARTERY DISEASE, NEW-ONSET ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE, STAGE IV CHRONIC KIDNEY DISEASE, MESENTERIC ADENOPATHY, CHRONIC LYMPHEDEMA, GASTROINTESTINAL BLEEDING, GASTRIC ULCER, THROMBOCYTOPENIA, AND ARTHRITIS, WHO UNDERWENT A IMPLANTATION OF A 26MM XT VALVE IN THE FAILED HOMOGRAFT ON (B)(6) 2015. THE INITIAL VALVE WAS DEPLOYED TOO VENTRICULAR WITHIN THE HOMOGRAFT, NECESSITATING DEPLOYMENT OF A SECOND 26MM XT VALVE. THIS EVENT WAS PREVIOUSLY DOCUMENTED UNDER COMPLAINT (B)(4) IN THE EDWARDS PILGRIM SYSTEM. APPROXIMATELY 10 YEARS AND 8 MONTHS POST-IMPLANTATION, THE PATIENT WAS HOSPITALIZED FOR GASTROINTEST

  Patient problems: Insufficient Information

  MAUDE report 23327611 ↗
• InjurySep 16, 2025Degraded; Degraded

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 7 YEARS POST TRANSFEMORAL TRANSCATHETER PULMONIC VALVE REPLACEMENT (TPVR) PROCEDURE WITH A 23 MM SAPIEN XT VALVE, THE VALVE WAS FAILING DUE TO REGURGITATION AND MODERATE TO SEVERE STENOSIS. A CATHETERIZATION REVEALED A PRE-PROCEDURAL PRESSURE GRADIENT OF >35 MMHG. THE INITIAL BALLOON DILATIONS WERE PERFORMED USING A 24 MM X 4 CM NON-EDWARDS BALLOON, FOLLOWED BY A 26 MM X 4 CM NON-EDWARDS BALLOON, WHICH SHOWED A SMALL WAIST. THE SAPIEN XT VALVE WAS DESCRIBED AS ''NAPKIN RINGED.'' A VALVE-IN-VALVE PROCEDURE WAS PERFORMED USING A 26 MM SAPIEN 3 VALVE, IMPLANTED WITH AN OVERFILL OF +3CC. A VISUAL GAP BETWEEN THE VALVE FRAMES WAS NOTED, PROMPTING A POST-DILATION WITH AN ADDITIONAL +1CC, WHICH RESULTED IN MINIMAL IMPROVEMENT. THE PRESSURE GRADIENT DECREASED TO APPROXIMATELY 15 MMHG. A FINAL BALLOON INFLATION USING A 26 MM X 4 CM NON-EDWARDS BALLOON AT 12 ATM FURTHER REDUCED THE GRADIENT TO AROUND 10 MMHG. INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CONFIRMED THAT THERE WAS NO RESIDUAL LEAK. NO PATIENT COMPLICATIONS WERE REPORTED.

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

  MAUDE report 23068579 ↗
• InjurySep 10, 2025Degraded; Degraded

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, A PATIENT WITH A 26 MM SAPIEN XT AORTIC VALVE IMPLANTED FOR 9 YEARS AND 8 MONTHS UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO STENOSIS AND CENTRAL LEAK WITH SHORT OF BREATH. THE PATIENT WAS TREATED WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE. THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: Dyspnea

  MAUDE report 23022705 ↗

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