Edwards SAPIEN 3 Ultra Transcatheter Heart ValveRecalls & reported problems across all models

We found 3 models of Edwards SAPIEN 3 Ultra Transcatheter Heart Valve by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 2,147 adverse event reports in the FDA's MAUDE database, received between Jan 19, 2021 and Aug 7, 2026 — classified as 115 deaths, 1,827 injuries, 205 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (518 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 3 Ultra Transcatheter Heart Valve problems

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve models

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

• Edwards SAPIEN 3 Ultra Transcatheter Heart Valve 9750TFX26

  Prosthesis, Mitral Valve, Percutaneously Delivered
  64 deaths1,070 reports
• Edwards SAPIEN 3 Ultra Transcatheter Heart Valve 9750TFX23

  Prosthesis, Mitral Valve, Percutaneously Delivered
  42 deaths936 reports
• Edwards SAPIEN 3 Ultra Transcatheter Heart Valve 9750TFX20

  Prosthesis, Mitral Valve, Percutaneously Delivered
  9 deaths141 reports

Recent Edwards SAPIEN 3 Ultra Transcatheter Heart Valve adverse event reports

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

• InjuryAug 7, 2026Degraded

  As reported by the Field Clinical Specialist (FCS), 5 years, 10 months, and 7 days post-implant of a 26 mm Sapien 3 Ultra valve in the aortic position, the 26 mm Sapien 3 Ultra valve required intervention due to stenosis and moderate central regurgitation. The aortic valve area (AVA) is not available, however the gradient was noted to be between 35-50mmHg. The patient was experiencing heart failure, dyspnea, and fatigue. A valve in valve was completed successfully using a Sapien 3 Ultra Resilia valve. The patient was in stable condition.

  Patient problems: Dyspnea; Fatigue; Heart Failure/Congestive Heart Failure

  MAUDE report 50174904 ↗
• InjuryAug 3, 2026Calcified

  As reported to the Implant Patient Registry (IPR), 6 years, 3 months, and 27 days post-implant of a 26 mm Sapien 3 Ultra valve in the aortic position, the 26 mm Sapien 3 Ultra valve was explanted due to calcification and an Inspiris Resilia was implanted.According to the medical records, the patient presented for a transcatheter aortic valve replacement (TAVR) vs surgical aortic valve replacement (SAVR) evaluation after a syncopal episode. The patient also reports constant shortness of breath at rest and with activity. TTE showed an ejection fraction (EF) of 65-70% and severely stenotic bioprosthetic aortic valve (26mm Sapien). The CT scan showed heavy calcifications of the TAVR leaflets. The patient went for TAVR a explant and a 23mm Inspiris was placed, and additionally the mitral valve was replaced with a 31mm Epic porcine valve. There were no procedural complications

  Patient problems: Dyspnea

  MAUDE report 50113664 ↗
• InjuryJun 25, 2026Insufficient Device Problem Information

  IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT A 20MM SAPIEN 3 ULTRA VALVE IMPLANTED IN THE AORTIC POSITION FOR 3 YEARS AND 1 MONTH WAS EXPLANTED. A SURGICAL VALVED CONDUIT WAS IMPLANTED IN REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 25630378 ↗
• InjuryJun 25, 2026Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, A PATIENT WITH A 26MM SAPIEN 3 ULTRA AORTIC VALVE IMPLANTED FOR 5 YEARS AND 5 MONTHS UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO STENOSIS. THE PATIENT ARRIVED TO THE OR ON IABP WITH SYMPTOMS OF CARDIOGENIC SHOCK. WITH SUBCLAVIAN CUTDOWN, A 23MM SAPIEN 3 ULTRA RESILIA VALVE WAS DEPLOYED WITH 3 EXTRA CC. THERE WAS TRACE LEAK WITH A MEAN OF 3MMHG. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Cardiogenic Shock

  MAUDE report 25630344 ↗
• InjuryJun 22, 2026Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), 3 YEARS, 6 MONTHS, AND 23 DAYS POST-IMPLANT OF A 26MM SAPIEN 3 ULTRA VALVE IN THE PULMONIC POSITION WITHIN A FAILED 25MM MAGNA EASE, THE 26MM SAPIEN 3 ULTRA VALVE REQUIRED INTERVENTION DUE TO STENOSIS. THE PEAK GRADIENT WAS 49MMHG AND MEAN GRADIENT WAS 30MMHG. THE PATIENT WAS EXPERIENCING EXERCISE INTOLERANCE, SHORTNESS OF BREATH, FATIGUE AND CHEST PAIN, HYPOXIA WITH MINIMAL ACTIVITIES. THE OPERATOR BALLOONED WITH A TRUE BALLOON AND THEN IMPLANTED THE 23MM SAPIEN 3 ULTRA RESILIA WITHOUT COMPLICATION. THE PATIENT WAS SENT TO RECOVERY AND SUBSEQUENTLY DISCHARGED. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT WAS EXPERIENCING PROGRESSIVE SHORTNESS OF BREATH AND FATIGUE WITH ACTIVITIES AND CARDIAC EXAM WAS SIGNIFICANT FOR LOWER HYPOXEMIA WITH LOWER PREDUCTAL SP02. AN ECHOCARDIOGRAM SHOWED INCREASED GRADIENT ON THE SAPIEN VALVE/PULMONARY STENOSIS AND SUBJECTIVELY DECREASED RIGHT VENTRICLE (RV) SYSTOLIC FUNCTION COMPARED TO PRIOR. A TTE WAS PROVIDED THAT SHOWED THE NEO-PULMONARY SAPIEN VALVE, MEAN GRADIENT OF 30MMHG, AND MILD INSUFFICIENCY. ANOTHER TTE S/P TRANSCATHETER PULMONIC VALVE REPLACEMENT (TPVR) SHOWED NO SIGNIFICANT PULMONARY S

  Patient problems: Dyspnea

  MAUDE report 25578711 ↗
• InjuryJun 22, 2026Patient Device Interaction Problem

  AS REPORTED BY THE PATIENTS CARE ADVOCATE AFTER A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 26MM SAPIEN 3 ULTRA VALVE THE PATIENT WAS IMPLANTED WITH A PACEMAKER BEFORE BEING DISCHARGED HOME. THE PATIENT WAS DEALING WITH SEVERAL ILLNESSES ALSO, INCLUDING STAGE 4 LUNG CANCER REQUIRING CHEMORADIATION TREATMENT AND FREQUENT HOSPITALIZATION. APPROXIMATELY 4 MONTHS AND 2 DAYS POST TAVR THE PATIENT WENT UNCONSCIOUS AT HOME, WAS TAKEN TO THE HOSPITAL, AND EXPIRED DUE TO UNKNOWN CAUSES.

  Patient problems: Heart Block

  MAUDE report 25577831 ↗
• InjuryJun 11, 2026Insufficient Device Problem Information

  AS REPORTED BY THE IMPLANT PATIENT REGISTRY TEAM, APPROXIMATELY 2 YEARS POST SUCCESSFUL TRANSCAVAL TRANSCATHETER AORTIC VALVE REPLACEMENT WITH A 26MM SAPIEN 3 ULTRA VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A 27MM SURGICAL HEART VALVE. THE REASON FOR EXPLANT IS UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 25478534 ↗
• InjuryJun 11, 2026Insufficient Device Problem Information

  EDWARDS RECEIVED NOTIFICATION FROM THE IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 9750TFX 26MM SAPIEN 3 ULTRA VALVE, IMPLANTED IN THE PULMONIC POSITION, UNDERWENT AN EXPLANT PROCEDURE AFTER AN IMPLANT DURATION OF (B)(6) DUE TO UNKNOWN REASONS. A 29MM EDWARDS SURGICAL VALVE WAS IMPLANTED IN REPLACEMENT. THE PATIENT'S POST OPERATIVE STATUS WAS NOTED AS, IN RECOVERY.

  Patient problems: Insufficient Information

  MAUDE report 25474422 ↗
• DeathJun 11, 2026Calcified

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) APPROXIMATELY 5 YEARS, 5 MONTHS AND 7 DAYS POST TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 26 MM SAPIEN 3 ULTRA VALVE THE VALVE WAS FAILING DUE TO AORTIC STENOSIS. ACCORDING TO THE PHYSICIAN THE PATIENT WAS IN CONGESTIVE HEART FAILURE (CHF) DUE TO THE AORTIC STENOSIS; THE PATIENT HAD COME TO THE HOSPITAL AND WAS TREATED, STABILIZED, AND SENT HOME. THE PATIENT WAS BEING WORKED UP FOR A TAVR REDO. THE PATIENT EXPIRED TWO DAYS AFTER BEING SEEN AT THE HOSPITAL, THE REASON FOR DEATH IS UNKNOWN. PER MEDICAL RECORDS THE VALVE HAD SEVERE BIOPROSTHETIC AORTIC VALVE STENOSIS AND THE CT OF THE HEART, SHOWED THE TAVR VALVE IN PLACE HOWEVER THE TAVR VALVE LEAFLETS ARE CALCIFIED. THE PATIENT WAS BROUGHT INTO THE EMERGENCY DEPARTMENT PRESENTING WITH SYNCOPE. THE PATIENT WAS NOTED TO HAVE POSITIVE CARDIAC MARKERS AND WAS ADMITTED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 25469503 ↗
• InjuryJun 11, 2026Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) APPROXIMATELY 4 YEARS, 9 MONTHS AND 30 DAYS POST TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 23MM SAPIEN 3 ULTRA VALVE THE VALVE FAILED DUE TO STENOSIS. A VALVE IN VALVE WAS PERFORMED USING A 20MM SAPIEN 3 ULTRA RESILIA VALVE. THERE WAS NO REPORT OF PATIENT INJURY, AND THE VALVE WAS SUCCESSFULLY IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 25469394 ↗
• InjuryJun 10, 2026Insufficient Device Problem Information

  AS REPORTED BY IMPLANT PATIENT REGISTRY (IPR), APPROXIMATELY 3 YEARS AND 6 MONTHS POST-IMPLANTATION OF A 26 MM SAPIEN 3 VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH, THE VALVE WAS EXPLANTED AND AN EDWARDS INSPIRIS SURGICAL VALVE WAS IMPLANTED. THE REASON FOR THE EXPLANT IS UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 25462155 ↗
• InjuryJun 9, 2026Device Stenosis

  PER THE FIELD CLINICAL SPECIALIST, APPROXIMATELY THREE YEARS AND THREE MONTHS POST-IMPLANTATION OF A 26 MM SAPIEN 3 ULTRA VALVE IN THE MITRAL POSITION WITHIN A PRE-EXISTING SURGICAL VALVE, THE PATIENT UNDERWENT A BALLOON MITRAL VALVULOPLASTY (BMV) TO TREAT STENOSIS.

  Patient problems: Insufficient Information

  MAUDE report 25447116 ↗
• InjuryJun 8, 2026Device Stenosis

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 5 YEARS AND 1 MONTH POST-IMPLANT OF A 26 MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH, THE VALVE FAILED DUE TO STENOSIS. A VALVE IN VALVE WAS PERFORMED WITH 26 MM SAPIEN 3 ULTRA RESILIA VALVE WITHOUT ANY COMPLICATION. A POST CATH GRADIENT OF 2 MM WAS RECORDED. NO PATIENT INJURIES AND THE TEAM DID NOT INDICATE EARLY FAILURE.

  Patient problems: Insufficient Information

  MAUDE report 25436701 ↗
• InjuryJun 8, 2026Degraded

  IT WAS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) THAT APPROXIMATELY 5 YEARS, 6 MONTHS AND 17 DAYS POST TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT WITH A 23MM SAPIEN 3 ULTRA VALVE, THE VALVE WAS FAILING. THE VALVE WAS EXPLANTED AND A SURGICAL VALVE WAS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 25428441 ↗
• InjuryJun 3, 2026Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 4 YEARS, 3 MONTHS, 17 DAYS POST TRANSFEMORAL TAVR PROCEDURE WITH A 23MM SAPIEN 3 ULTRA VALVE, THE VALVE PRESENTED STENOSIS WITH AN AVA OF 0.58, A MEAN GRADIENT OF 47MMHG, VELOCITY 4.6, DI 0.34, SVI 32, EF 60-65%. THERE IS NO INTERVENTION PLANNED. THE PATIENT WAS TREATED WITH A 20MM SAPIEN 3 ULTRA RESILIA VALVE. THE INITIAL 23MM SAPIEN 3 ULTRA VALVE WAS DILATED WITH A 22MM TRU BALLOON, THEN THE 20MM SAPIEN 3 ULTRA RESILIA VALVE WAS IMPLANTED WITH +1CC WITHOUT ISSUE. THE PATIENT LEFT THE ROOM IN STABLE CONDITION. PER THE PHYSICIAN NOTES, THE ECHOCARDIOGRAM SHOWS SEVERE STENOSIS, VELOCITY 4.5 M/S, MEAN GRADIENT 50MMHG. THE PATIENT TIRES OUT EASILY WITH WALKING. NYHA CLASS II TO III, MODERATE EXERTION MOSTLY. THE PATIENT HAS TO STOP WITH WALKING IN FROM THE PARKING LOT. THE PATIENT DENIES LEG SWELLING, SYNCOPE, OR PRESYNCOPE, AND DENIES CHEST PAIN. THE PATIENT IS NOT VERY ACTIVE, BUT DOES THE COOKING AND CLEANING, AND STILL DRIVES. THE PATIENT DOES NOT USE A WALKER, AND LIVES WITH HUSBAND.

  Patient problems: Dyspnea

  MAUDE report 25377841 ↗

Other Edwards Lifesciences LLC products

• Edwards SAPIEN 315 models · 6,905 reports · 1 recall
• EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)4 models · 2,986 reports · 1 recall
• INSPIRIS RESILIA AORTIC VALVE6 models · 1,305 reports
• EDWARDS ESHEATH INTRODUCER SET4 models · 973 reports
• SAPIEN 3 Ultra RESILIA4 models · 881 reports
• SAPIEN 3 Ultra System3 models · 876 reports
• FOGARTY32 models · 486 reports · 3 recalls
• EDWARDS COMMANDER DELIVERY SYSTEM4 models · 261 reports · 1 recall