Edwards SAPIEN 3 Ultra Transcatheter Heart Valve 9750TFX26Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,070 adverse event reports that list this exact device (DI 00690103201338), received between Jan 19, 2021 and Aug 7, 2026 — classified as 64 deaths, 852 injuries, 154 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (250 reports).

3 other recalls cover devices cleared under the same FDA submission (P140031); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,070 reports, 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, 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 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 ↗
• InjuryMay 29, 2026Migration or Expulsion of Device

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, DURING A TRANSFEMORAL TAVR PROCEDURE WITH A 26 MM COMMANDER DELIVERY SYSTEM, THE BALLOON WAS OVER-ALIGNED WHILE POSITIONED IN THE DESCENDING AORTA. THE VALVE WAS NOT POSITIONED BETWEEN THE ALIGNMENT MARKERS. THIS WAS IDENTIFIED PRIOR TO DEPLOYMENT. AN ATTEMPT WAS MADE TO RETRACT THE VALVE INTO THE SHEATH TO REMOVE THE SYSTEM AS A SINGLE UNIT AND RESTART THE PROCEDURE; HOWEVER, THE VALVE COULD NOT BE RE-SHEATHED. THE PHYSICIAN WANTED TO PARTIALLY DEPLOY THE VALVE, COME DOWN ON THE BALLOON, GENTLY ADVANCE THE BALLOON AND THEN GO BACK UP ON THE BALLOON FOR FULL VALVE DEPLOYMENT. THE FIRST COMMANDER BALLOON INFLATION ONLY FLARED THE OUTFLOW PORTION OF THE VALVE. AT THAT TIME, THE VALVE WAS STABLE WITHIN THE ANNULUS, AND THE PATIENT REMAINED STABLE. THE PHYSICIAN WITHDREW THE DELIVERY SYSTEM FROM THE PATIENT AND ATTEMPTED TO USE A NON-EDWARDS BALLOON FOR A SECOND INFLATION FOCUSING ON THE INFLOW SECTION OF THE VALVE. WHEN ATTEMPTING TO CROSS THROUGH THE VALVE, THE VALVE PUSHED THROUGH INTO THE LEFT VENTRICLE. THE PATIENT REMAINED STABLE AND WAS TAKEN TO THE OPERATING ROOM FOR RETRIEVAL OF THE TRANSCATHETER VALVE FROM THE LEFT VENTRICLE. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25338041 ↗
• InjuryMay 29, 2026Calcified; Perivalvular Leak

  AS REPORTED BY PATIENT SUPPORT, APPROXIMATELY FOUR YEARS AND TEN MONTHS POST TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) IMPLANT USING A 26 MM SAPIEN 3 ULTRA VALVE, THE PATIENT VISITED HIS PRIMARY DOCTOR FOR COMPLAINTS OF SHORTNESS OF BREATH. BASED ON HIS LAB RESULTS, THE PATIENT WAS THEN REFERRED TO SPECIALISTS AT (B)(6). NEPHROLOGY AND INFECTIOUS DISEASE TEAMS DIAGNOSED THE PATIENT WITH STAGE 4 KIDNEY FAILURE RELATED TO AUTOIMMUNE DISEASE. AS A RESULT, PATIENT WAS WORKED UP FOR RECOMMENDED HIGH DOSE STEROID TREATMENT. THE PROPOSED TREATMENT REQUIRED THE PATIENT TO BE NEGATIVE FOR ENDOCARDITIS, AND AN ECHO WAS PERFORMED (4 YEARS AND 9 MONTHS). HOWEVER, THE REPORT FOUND "REGURGITATION AND STENOSIS" ON HIS OLD TAVR VALVE. AS A RESULT, PATIENT'S STEROID TREATMENT WAS HALTED FOR PLANS TO REPLACE HIS OLD TAVR VALVE. PATIENT WAS REFERRED TO HIS CARDIOLOGY TEAM AND HAS UNDERGONE EVALUATIONS INCLUDING A HEART CATHETERIZATION. CURRENTLY, THE PATIENT IS SCHEDULED FOR VALVE IN VALVE (VIV) TAVR ON (B)(6) 2026. ACCORDING TO THE MEDICAL RECORD A TRANSTHORACIC ECHOCARDIOGRAM (TTE) PERFORMED APPROXIMATELY 4 YEARS AND 10 MONTHS POST IMPLANT, NOTED MODERATE-SEVERE AORTIC VALVE PROSTHETIC STENOSIS

  Patient problems: Dyspnea

  MAUDE report 25333663 ↗
• InjuryMay 28, 2026Perivalvular Leak

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 1 YEAR AND 10 MONTHS AFTER A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE TO IMPLANT A 26 MM SAPIEN 3 ULTRA VALVE, THE PATIENT PRESENTED WITH WEAKNESS, DYSPNEA AND CHRONIC ANEMIA. THE VALVE EXHIBITED SEVERE PARAVALVULAR LEAK (PVL). AN ATTEMPT WAS MADE TO PLUG THE PVL WHICH WAS UNSUCCESSFUL. THE PATIENT WAS STABLE AT END OF PROCEDURE. THE ROOT CAUSE OF THE EVENT WAS ATTRIBUTED TO CALCIUM ON THE NATIVE LEAFLET THAT DID NOT ALLOW FOR FULL EXPANSION OF THE THV. THE PATIENT WILL RETURN FOR ANOTHER ATTEMPT TO PLUG THE LEAK VIA RADIAL APPROACH.

  Patient problems: Anemia; Dyspnea

  MAUDE report 25322377 ↗
• InjuryMay 27, 2026Calcified

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT A PATIENT WITH A 26MM SAPIEN 3UR VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT A VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 2 YEARS AND 11 MONTHS. A 26MM EDWARDS TRANSCATHETER VALVE WAS IMPLANTED SUCCESSFULLY. AFTER A REVIEW OF THE MEDICAL RECORD, THE PATIENT PRESENTED FOR A VALVE IN VALVE TAVR. PRE VIV TEE REVEALED THE VALVE HAD LEAFLETS WITH THICKENED AND CALCIFIED LEAFLETS. THE MEAN GRADIENT WAS 23MM HG WITH AT LEAST MODERATE AORTIC REGURGITATION (NOT SPECIFIED). THESE FINDINGS ARE SIMILAR TO ECHO ONE YEAR PRIOR. PRE VIV DIAGNOSIS ON THE OPERATIVE NOTE WAS NOTED AS "SEVERE SYMPTOMATIC AORTIC STENOSIS".

  Patient problems: Insufficient Information

  MAUDE report 25303480 ↗
• InjuryMay 26, 2026Device Stenosis

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, APPROXIMATELY 5 YEARS AND 9 MONTHS POST IMPLANTATION OF A 26MM SAPIEN 3 VALVE IN THE AORTIC POSITION, A VALVE IN VALVE WITH A 26MM SAPIEN 3 ULTRA RESILA VALVE DUE TO VALVE STENOSIS. PATIENT SYMPTOMS BEFORE THE VALVE IN VALVE WAS NOT PROVIDED.

  Patient problems: Stenosis

  MAUDE report 25281020 ↗
• InjuryMay 18, 2026Migration or Expulsion of Device

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, DURING NATIVE AI OFF-LABEL CASE, THIS FIRST 26MM SAPIEN 3 ULTRA RESILIA VALVE DRIFTED VENTRICULAR. A 2ND VALVE PLACED IN A MORE AORTIC POSITION TO ANCHOR 1ST VALVE. THERE WAS NO ALLEGATION THAT THE EW DEVICES WERE DEFICIENT IN ANY WAY. THE ROOT CAUSE FOR THE INITIAL VALVE MIGRATING TOWARD THE LEFT VENTRICLE AFTER DEPLOYMENT WAS THAT FACT THAT THIS WAS AN OFF LABEL AI CASE AND THE LACK OF CALCIUM TO ANCHOR THE VALVE. THIS WAS A KNOWN RISK AND DISCUSSED WITH THE IMPLANTERS PRIOR TO THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 25204066 ↗
• InjuryMay 18, 2026Perivalvular Leak

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), A PATIENT UNDERWENT A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 26 MM SAPIEN 3 ULTRA VALVE IN AORTIC POSITION. APPROXIMATELY 4 YEARS AND 5 MONTHS LATER, THE PATIENT IS PRESENTING WITH MODERATE PARAVALVULAR LEAK (PVL). THE PATIENT IS CURRENTLY ADMITTED FOR DYSPNEA ON EXERTION AND WEAKNESS AS WELL AS OSTEOMYELITIS. THE PATIENT IS SCHEDULED FOR TOE AND PARTIAL FOOT AMPUTATION. THE TEAM IS LOOKING AT OPTIONS FOR TREATING THE VALVE, IF/WHEN SAFE TO DO SO. PATIENT WAS ALSO HOSPITALIZED IN 2022 FOR TAVR VALVE ENDOCARDITIS. PER RECEIPT OF MEDICAL RECORDS, APPROXIMATELY 8 MONTHS POST IMPLANT A TEE WAS PERFORMED. THE INDICATION FOR THE EXAM WAS STATUS POST WATCHMAN PROCEDURE. RESULTS OF THE EXAM NOTED THE VALVE APPEARS WELL SEATED, WITH MILD POSTERIOR PARAVALVULAR LEAK AND NO CENTRAL REGURGITATION, NO EVIDENCE OF AORTIC STENOSIS. THE EXAM ALSO NOTED A 27MM WATCHMAN FLX DEVICE APPEARS WELL SEATED WITH MILD PVL AND NO CENTRAL REGURGITATION. THE PATIENT WAS DISCHARGED TO HOME THE SAME DAY. PROGRESS NOTES FROM A STRUCTURAL HEART CONSULTATION 4 YEARS AND 5 MONTHS POST IMPLANT NOTED THAT THE REASON FOR THE VISIT WA

  Patient problems: Dyspnea

  MAUDE report 25202672 ↗
• InjuryMay 15, 2026Perivalvular Leak

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 2 YEARS AND 2 MONTHS POST-IMPLANT OF A 26 MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH, THE PATIENT HAD DEVELOPED MODERATE PARAVALVULAR LEAK (PVL) AND EXPERIENCING SHORTNESS OF BREATH WITH ACTIVITY. A 26 MM COMMANDER THAT WAS PREPPED WITH AN ADDITIONAL 3CC WAS USED TO POST DILATE THE 26 MM S3U VALVE. THE PVL DID IMPROVE FROM MODERATE TO MILD. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Dyspnea

  MAUDE report 25194068 ↗
• InjuryMay 15, 2026Insufficient Device Problem Information

  AS REPORTED TO THE IMPLANT REGISTRY TEAM, APPROXIMATELY 11 MONTHS POST SUCCESSFUL MITRAL TRANSCATHETER VALVE REPLACEMENT WITH A 26MM SAPIEN 3 ULTRA VALVE, THE VALVE WAS EXPLANTED WITH A 27MM MAGNA MITRAL EASE VALVE. THE REASON FOR EXPLANT IS UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 25188812 ↗
• InjuryMay 11, 2026Insufficient Device Problem Information

  IT WAS REPORTED VIA THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY, APPROXIMATELY 3 YEARS AND 7 MONTHS POST IMPLANTATION OF A 26MM SAPIEN 3 ULTRA VALVE IN THE MITRAL POSITION, THE VALVE WAS EXPLANTED. THE CAUSE OF THE EXPLANT AND SYMPTOMS BEFORE THE EXPLANT WERE NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25142861 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 2 YEARS AND 3 MONTHS POST-IMPLANT OF A 26 MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH. IT WAS INITIALLY REPORTED THAT THE VALVE FAILED DUE TO STENOSIS WITH A SUSPECTED HALT AND GRADIENT OF 30MMHG. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT WAS DIAGNOSED WITH ENDOCARDITIS AND AFTER 6 WEEKS OF ANTIBIOTICS WILL REPEAT CULTURES. THE TEAM IS PLANNING FOR TAVR IN TAVR ONCE CLEARED BY INFECTIOUS DISEASE (ID). ADDITIONAL INFORMATION RECEIVED, CTA REVIEW OBSERVED SEVERE HALT WITH HEMODYNAMIC CONSEQUENCE. IN A SYMPTOMATIC PATIENT, THIS IS NOT SUBCLINICAL LEAFLET THICKENING AND WAS CONSISTENT WITH VALVE THROMBOSIS. THE PATIENT WAS TREATED WITH A NON-EW VALVE. THE PATIENT DID WELL AND WAS STABLE IN THE RECOVERY AREA POST RETREATMENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25034250 ↗
• InjuryApr 22, 2026Calcified

  AS REPORTED BY IMPLANT PATIENT REGISTRY, APPROXIMATELY 3 YEARS AND 5 MONTHS POST TRANSFEMORAL TAVR PROCEDURE WITH A 26MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION THE VALVE WAS EXPLANTED DUE TO UNKNOWN REASONS. AFTER REVIEWING THE MEDICAL RECORDS PROVIDED, THE PATIENT IS A 67-YEAR-OLD FEMALE, WITH A PAST MEDICAL HISTORY SIGNIFICANT FOR AORTIC STENOSIS, HEART FAILURE WITH PRESERVED EJECTION FRACTION, PULMONARY HYPERTENSION, HYPERTENSION, TYPE II DIABETES MELLITUS, AUTOIMMUNE LIVER DISEASE, ESOPHAGEAL VARICES, AND TOBACCO ABUSE, WHO UNDERWENT IMPLANTATION OF A 23 MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION ON (B)(6) 2022. APPROXIMATELY 3 YEARS AND 4 MONTHS POST-IMPLANTATION, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2026, WITH SYNCOPE AND LOSS OF CONSCIOUSNESS. DUE TO VALVE DEGENERATION, THE 23 MM SAPIEN 3 ULTRA VALVE WAS EXPLANTED ON (B)(6) 2026. ECHOCARDIOGRAPHIC EVALUATIONS DEMONSTRATED SEVERE BIOPROSTHETIC AORTIC STENOSIS WITH DIFFUSE LEAFLET THICKENING AND MODERATE LEAFLET CALCIFICATIONS, CONSISTENT WITH LEAFLET THROMBOSIS/HYPO-ATTENUATED LEAFLET THICKENING AND AVA OF 0.7CM2. PATHOLOGIC EXAMINATION OF THE EXPLANTED VALVE DESCRIBED THREE TAN-BROWN, RUBBERY,

  Patient problems: Syncope/Fainting

  MAUDE report 24957667 ↗
• InjuryApr 22, 2026Calcified; Perivalvular Leak; Insufficient Device Problem Information

  AS REPORTED BY EDWARDS IMPLANT PATIENT REGISTRY (IPR), APPROXIMATELY FIVE (5) YEARS, FIVE (5) MONTHS, AND TWENTY-ONE (21) DAYS POST TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 26 MM SAPIEN 3 ULTRA VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A 25 MM SURGICAL VALVE. MEDICAL RECORDS WERE RECEIVED FOR EVALUATION. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT PRESENTED RECENTLY WITH INCREASING SHORTNESS OF BREATH. AN ECHOCARDIOGRAM PERFORMED APPROXIMATELY FIVE (5) YEARS, ONE (1) MONTH, AND TWENTY-NINE (29) DAYS POST TAVR PROCEDURE SHOWED SEVERE AORTIC STENOSIS OF THE TAVR VALVE THAT WAS WELL-SEATED WITH A VALVE AREA OF 0.9 CM2, A MEAN GRADIENT OF 50 MMHG, MODERATE PARAVALVULAR LEAK (PVL) AND NO OBVIOUS AORTIC REGURGITATION. A COMPUTED TOMOGRAPHY (CT) WAS ALSO PERFORMED, AND IT REVEALED THE PRESENCE OF CALCIUM IN THE LEAFLETS OF THE TAVR VALVE. APPROXIMATELY THREE (3) MONTHS AND TWENTY-THREE (23) DAYS LATER, THE PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT PROCEDURE DURING WHICH THE TRANSCATHETER HEART VALVE (THV) WAS EXPLANTED AND REPLACED WITH A 25 MM SURGICAL VALVE. PRIOR TO THE PROCEDURE, THE PRE-OPERATIVE DIAGNOSIS WAS STENOSIS OF THE PROSTHETIC

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 24957316 ↗
• InjuryApr 20, 2026Insufficient Device Problem Information

  IT WAS REPORTED VIA EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY, APPROXIMATELY 5 YEARS AND 8 MONTHS POST IMPLANTATION OF A 26MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION, A VALVE IN VALVE WAS PERFORMED. THE REASON FOR THE VALVE IN VALVE AND PATIENT SYMPTOMS BEFORE THE VALVE IN VALVE NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24927354 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140031. One submission often covers many models, so check the product and lot details in each record.

• Z-0835-2019 · Jan 22, 2019 · Terminated
  Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930 9600LDS20J 00690103194852 9600LDS23A (US) 00690103193947 9600LDS
• Z-2435-2018 · Jun 11, 2018 · Terminated
  Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
• Z-0293-2018 · Jul 21, 2017 · Terminated
  Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Certitude Delivery System is used for delive