Edwards SAPIEN 3 Ultra Transcatheter Heart Valve 9750TFX23Recalls & reported problems

Summary

The FDA's MAUDE database contains 936 adverse event reports that list this exact device (DI 00690103201321), received between Feb 8, 2021 and Jun 11, 2026 — classified as 42 deaths, 849 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (236 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 936 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• InjuryJun 2, 2026Degraded

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 5 YEARS AND 7 MONTHS POST-IMPLANT OF A 23 MM SAPIEN 3 VALVE IN THE AORTIC POSITION, THE 23 MM SAPIEN 3 VALVE WAS NOTED TO BE FAILING DUE TO INCREASED GRADIENTS AND CENTRAL REGURGITATION. THE 23 MM SAPIEN 3 VALVE WAS EXPLANTED WITH REDO AORTIC VALVE REPLACEMENT (AVR) USING A 23 MM INSPIRIS PERICARDIAL VALVE AND ENLARGEMENT OF THE NON-CORONARY CUSP WITH BOVINE PERICARDIAL PATCH VIA MEDIAN STERNOTOMY AND TEE. THE PATIENT WAS DISCHARGED. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT WAS SEEN WITH COMPLAINTS OF WORSENING SHORTNESS OF BREATH AND CHEST TIGHTNESS AND HAD A CONSULTATION FOR SEVERE BIOPROSTHETIC AORTIC STENOSIS. THE TTE SHOWED THE PROSTHETIC VALVE WAS PRESENT BUT MALFUNCTIONING, WITH CRITICAL STENOSIS, MODERATE REGURGITATION, A MEAN GRADIENT IS 80MMHG, AND AN AVA OF 0.39CM^2.

  Patient problems: Dyspnea

  MAUDE report 25361481 ↗
• InjuryJun 1, 2026Perivalvular Leak

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, A PATIENT WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION DEVELOPED MODERATE PVL AT ONE YEAR, AND NOW IT IS SEVERE PVL. THE TEAM USED 24MM TRUE BALLOON TO DILATE VALVE. POST BALLOON DILATION, NO PVL WAS PRESENT.

  Patient problems: Fatigue; Insufficient Information

  MAUDE report 25355225 ↗
• InjuryJun 1, 2026Insufficient Device Problem Information

  AS REPORTED BY IMPLANT PATIENT REGISTRY, APPROXIMATELY 3 YEARS AND 2 WEEKS POST TRANSFEMORAL TAVR PROCEDURE WITH A 29 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION THE VALVE WAS EXPLANTED DUE TO UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 25349435 ↗
• InjuryMay 29, 2026Perivalvular Leak

  AS REPORTED BY THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY, WHO RECEIVED INFORMATION FROM BOTH THE HOSPITAL AND THE PATIENT'S CARE ADVOCATE, A 23MM SAPIEN 3 ULTRA VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 MONTHS. PER THE MEDICAL RECORD, THE PATIENT WAS BROUGHT BACK TO THE CATHETERIZATION LAB TO ADDRESS ONGOING PARAVALVULAR LEAK (PVL). THE TEE DEMONSTRATED A BROAD JET OF PVL LIKELY DUE TO UNDER-SIZING OF THE TRANSCATHETER HEART VALVE. THE PLAN WAS TO PERFORM A VALVULOPLASTY; HOWEVER, AFTER FULL INFLATION WITH +2 ML OF VOLUME, RESIDUAL PVL REMAINED. THEREFORE, A 26 MM SAPIEN 3 ULTRA RESILIA VALVE WAS IMPLANTED INSIDE THE PRIOR 23MM SAPIEN 3 ULTRA VALVE WITH EXCELLENT RESULTS AND RESOLUTION OF THE PVL.

  Patient problems: Insufficient Information

  MAUDE report 25333187 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED FROM FCS, APPROXIMATELY 5 YEARS AND 10 MONTHS POST TAVR WITH A 23 MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION, THE PATIENT HAS A VALVE FRAME THAT LOOKS TO HAVE LEAFLET THICKENING ON ALL 3 LEAFLETS AND A SLIGHTLY UNDER-EXPANDED FRAME BASED ON CT MEASUREMENTS OF 21.1 X 20.1 X 22.1 FOR A 23 IMPLANT. THE TEAM HAS ASKED IF THE PATIENT HAS SYMPTOMS, HAS BEEN ON ANTICOAGULATION, AND WHAT THE TREATMENT PLAN IS FOR THEM. UPON FOLLOW UP THE FCS ADVISED THAT THE PATIENT HAS HALT OF THE NON CORONARY CUSP AND WAS STARTED ON WARFARIN FOR 2 MONTHS WITH DRAMATIC IMPROVEMENT OF GRADIENTS TO 8 MMHG AND SIGNIFICANT RESOLUTION OF THE TAVR HALT. THE VALVE APPEARS TO BE SLIGHTLY UNDER EXPANDED AND THE PHYSICIAN BELIEVES THAT THE PATIENT WILL BENEFIT FROM A BAV WITH A 22 TRUE BALLOON WITH SENTINEL PROTECTION. THE BAV IS SCHEDULED FOR (B)(6) 2026.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25280749 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, APPROXIMATELY 5 YEARS A 4 MONTHS POST TAVR WITH A 23MM SAPIEN 3 ULTRA VALVE, A VALVE IN VALVE PROCEDURE WAS COMPLETED DUE TO UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 25280623 ↗
• InjuryMay 26, 2026Perivalvular Leak

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), A PATIENT UNDERWENT A TRANSCAROTID TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 23MM SAPIEN 3 ULTRA VALVE IN AORTIC POSITION AT 70/30 WITH MILD PARAVALVULAR LEAK FOLLOWING THE PROCEDURE. APPROXIMATELY 1 YEAR AND 11 MONTHS LATER, THE PATIENT PRESENTED WITH MODERATE TO SEVERE PARAVALULAR LEAK (PVL). A 23MM CERTITUDE DELIVERY SYSTEM WAS PREPPED WITH AN ADDITIONAL 4CC AND USED TO POST DILATE THE VALVE. POST BALLOON VALVULOPLASTY, THE PVL DECREASED TO MILD PER TEE ASSESSMENT. THE PATIENT TOLERATED THE PROCEDURE WITHOUT COMPLICATIONS. THERE WAS NO ALLEGATION OF AN EDWARDS DEVICE DEFICIENCY. PER FOLLOW-UP WITH THE FCS, THE IMPLANTING PHYSICIAN REPORTED THAT THE PATIENT WAS EXPERIENCING SHORTNESS OF BREATH WITH ACTIVITY. THE PERCEIVED ROOT CAUSE OF THE PVL IS UNKNOWN.

  Patient problems: Dyspnea

  MAUDE report 25280151 ↗
• InjuryMay 26, 2026Insufficient Device Problem Information

  AS REPORTED BY IMPLANT PATIENT REGISTRY, A PATIENT UNDERWENT EXPLANT OF THEIR 23MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION APPROXIMATELY 6 YEARS POST TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE DEVICE WAS EXPLANTED FOR AN UNKNOWN REASON AND REPLACED WITH AN EDWARDS SURGICAL VALVE.

  Patient problems: Insufficient Information

  MAUDE report 25278786 ↗
• MalfunctionMay 22, 2026Material Deformation

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), DURING A TAVR PROCEDURE WITH A 23MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION, THE FIRST VALVE GOT CAUGHT IN THE ESHEATH. THE ENTIRE SYSTEM WAS REMOVED AND A 2ND VALVE AND DELIVERY SYSTEM WAS PLACED WITH GOOD RESULT. DURING DELIVERY SYSTEM INTRODUCTION INTO SHEATH, THE VALVE WOULD NOT ADVANCE IN THE SHEATH. IT WAS NOTICED THAT A TINE OF THE VALVE WAS LIFTED AWAY FROM PREPPED SYSTEM AND WAS CATCHING IN THE SHEATH. UPON FOLLOW UP, THE FCS ADVISED THAT DURING A TAVR PROCEDURE, NO DIFFICULTY WAS ENCOUNTERED DURING INSERTION OF THE ESHEATH, AND THE EXPANSION TOOL (ESHEATH+) AND LOADER WERE USED APPROPRIATELY WITH FULL INSERTION ACHIEVED. THE ESHEATH WAS INTRODUCED VIA RIGHT-SIDED ACCESS AT A STEEP ANGLE. THE DELIVERY SYSTEM AND VALVE DID NOT EXIT THE SHEATH, BECOMING LODGED NEAR THE TRANSITION BETWEEN THE BLUE AND WHITE PORTIONS OF THE SHEATH. THE SYSTEM WAS WITHDRAWN FROM THE PATIENT AS A SINGLE UNIT, AND INSPECTION IDENTIFIED A SMALL PINHOLE IN THE SHEATH. THE DEVICE HAD BEEN PREPARED AND THE VALVE CRIMPED PER IFU, WITH NO ISSUES DURING THE CRIMPING PHASE. NO VESSEL PRE-DILATION WAS PERFORMED. THE ORIGINAL SYSTEM WAS REMOVED AND REPL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25256659 ↗
• InjuryMay 21, 2026Perivalvular Leak; Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, A PATIENT WITH A 23MM SAPIEN 3 ULTRA AORTIC VALVE IMPLANTED FOR 5 YEARS AND 2 MONTHS UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO STENOSIS AND MODERATE PERIVALVULAR LEAK. THE PATIENT WAS SYMPTOMATIC WITH DYSPNEA AND HEMOLYSIS. A 23MM SAPIEN 3 ULTRA RESILIA VALVE WAS SUCCESSFULLY IMPLANTED AND PERIVALVULAR LEAK WAS REDUCED TO MILD. THE PATIENT TOLERATED THE PROCEDURE WELL AND LEFT THE OR IN STABLE CONDITION.

  Patient problems: Dyspnea; Hemolysis

  MAUDE report 25250311 ↗
• DeathMay 21, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S CARE ADVOCATE CONTACTED EDWARDS LIFESCIENCES PATIENT SUPPORT AFTER RECEIVING THE PATIENT'S IMPLANT ID CARD. THE CARE ADVOCATE NOTIFIED PATIENT SUPPORT THAT THE PATIENT PASSED AWAY ON THE SAME DAY AS THE IMPLANT OF THE SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE IN THE AORTIC POSITION. WHEN ASKED ABOUT THE CAUSE OF DEATH, THE CARE ADVOCATE EXPLAINED THAT THE TAVR PROCEDURE ITSELF WAS SUCCESSFUL, AS THE IMPLANTING PHYSICIAN REPORTED THAT THE PROCEDURE WENT WELL. HOWEVER, WHILE THE PATIENT WAS IN THE RECOVERY ROOM AND REGAINING CONSCIOUSNESS, THEY EXPERIENCED A SUDDEN AND SIGNIFICANT DROP IN BLOOD PRESSURE. ATTEMPTS TO REVIVE THE PATIENT WERE UNSUCCESSFUL. THE CARE ADVOCATE MADE NO ALLEGATIONS REGARDING THE DEVICE. PER MEDICAL RECORD, THE PATIENT UNDERWENT SUCCESSFUL TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) FOR SEVERE SYMPTOMATIC AORTIC STENOSIS. AT PROCEDURE COMPLETION, INTRAOPERATIVE IMAGING DEMONSTRATED NO PARAVALVULAR LEAK OR PERICARDIAL EFFUSION AND THE PATIENT WAS TRANSFERRED TO THE POST ANESTHESIA CARE UNIT IN STABLE CONDITION. THERE WERE NO IMMEDIATE COMPLICATIONS. APPROXIMATELY 1-HOUR LATER, THE PATIENT DEVELOPED ACUTE HYPOTENSION AND WAS FOUND TO

  Patient problems: Bradycardia; Cardiac Arrest; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 25249236 ↗
• InjuryMay 21, 2026Device Stenosis

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT A 23MM SAPIEN 3 VALVE, IMPLANTED IN THE MITRAL POSITION FOR 9 MONTHS, IS FAILING DUE TO STENOSIS. THE PATIENT IS SYMPTOMATIC WITH SHORTNESS OF BREATH (SOB), FATIGUE, AND LOWER EXTREMITY (LE) EDEMA. THE PLAN IS FOR THE PATIENT TO UNDERGO AN OPEN SURGICAL PROCEDURE. PER THE VCC, THE PROCEDURE HAS NOT BEEN SCHEDULED AS OF YET. THEY ARE PLANNING ON REPEATING A R/LHC/TEE PRIOR TO SURGERY.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 25244640 ↗
• InjuryMay 20, 2026Perivalvular Leak

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT OF A 23MM SAPIEN 3 ULTRA VALVE, APPROXIMATELY 5 YEARS POST OP THE PATIENT WAS SCHEDULED FOR PARAVALVULAR LEAK CLOSURE WITH A POSSIBLE VALVE IN VALVE. THE LEAK WAS GRADED MODERATE ON A TRANSESOPHAGEAL ECHOCARDIOGRAM. HOWEVER, THE DAY OF THE PROCEDURE IN THE OPERATING ROOM THE TRANSESOPHAGEAL ECHOCARDIOGRAM AND AORTGRAM REVEALED MILD PARAVALVULAR LEAK. DUE TO THIS INFORMATION, THE TEAM DECIDED TO CLOSE THE LEAK WITH A 6 X 6 VASCULAR PLUG INSTEAD OF DOING A VALVE IN VALVE, WHICH RESULTED IN TRACE PARAVALVULAR LEAK. THE PROCEDURE WAS SUCCESSFUL AND THE PATIENT IS NOW STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233889 ↗
• InjuryMay 15, 2026Degraded

  IT WAS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), THAT APPROXIMATELY 6 YEARS, 8 MONTHS POST TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 23 MM SAPIEN 3 VALVE, THE PATIENT'S PEAK AORTIC VALVE VELOCITY IS 500 CM/SEC WITH A MEAN PRESSURE GRADIENT OF 66 MMHG, AND THE CALCULATED AVA WAS 0.60 CM2. DUE TO STENOSIS, THE PATIENT WAS SCHEDULED FOR A VALVE-IN-VALVE PROCEDURE WITH A COMPETITOR'S PRODUCT. DURING INVESTIGATION, IT WAS IDENTIFIED THAT THE PATIENT NEVER RECEIVED THE VALVE-IN-VALVE PROCEDURE. THEY WERE TRANSFERRED TO THE OPERATING ROOM (OR) AND THEN THE PROCEDURE WAS CANCELLED. THE PATIENT EXPIRED THE NEXT DAY WITH CAUSE OF DEATH REPORTED AS AORTIC DISSECTION.

  Patient problems: Insufficient Information

  MAUDE report 25191789 ↗
• InjuryMay 14, 2026Calcified

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, APPROXIMATELY (B)(6) POST IMPLANT OF A 23MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION, THE PATIENT WAS BEING EVALUATED FOR A THV-IN-THV PROCEDURE. PER PROCTOR REVIEW, THE PATIENT IS PRESENTING WITH STRUCTURAL VALVE DETERIORATION, MANIFESTING AS CENTRAL AORTIC REGURGITATION. THE PROSTHETIC LEAFLETS DEMONSTRATE CALCIFICATION AND EARLY FIBROTIC CHANGES. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT PASSED AWAY AFTER APPROXIMATELY (B)(6) POST IMPLANT. PER THE MEDICAL RECORD, THE PATIENT WAS ADMITTED WITH COLITIS AND GI SYMPTOMS OF ABDOMINAL PAIN, VOMITING & DIARRHEA AND DEVELOPED REFRACTORY HYPOTENSION REQUIRING VASOPRESSOR SUPPORT, CONSISTENT WITH SEPSIS. DURING THIS HOSPITALIZATION, AN ECHO DEMONSTRATED CHRONICALLY ELEVATED GRADIENTS ACROSS THE PREVIOUSLY IMPLANTED TAVR AORTIC VALVE WITH MODERATE CENTRAL REGURGITATION; HOWEVER, LEFT VENTRICULAR SYSTOLIC FUNCTION REMAINED PRESERVED, NO VALVULAR THROMBUS OR VEGETATIONS WERE IDENTIFIED, AND CARDIOLOGY ASSESSED THAT THE ELEVATED GRADIENTS WERE EXACERBATED BY A HIGH OUTPUT STATE RELATED TO SEPSIS, ANEMIA, AND ARTERIOVENOUS DIALYSIS ACCESS RATHER THAN ACUTE DEVICE MALFU

  Patient problems: Dyspnea

  MAUDE report 25178364 ↗
• InjuryMay 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED BY IMPLANT PATIENT REGISTRY, THAT APPROXIMATELY 4 YEARS, 29 DAYS POST TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 23MM SAPIEN 3 ULTRA VALVE, THE VALVE WAS EXPLANTED AND A SURGICAL VALVE WAS IMPLANTED. THE REASON FOR EXPLANT IS UNKNOWN AT THE TIME OF REPORT.

  Patient problems: Insufficient Information

  MAUDE report 25155122 ↗
• InjuryMay 11, 2026Device Stenosis

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, A PATIENT UNDERWENT A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 23MM SAPIEN 3 ULTRA VALVE IN AORTIC POSITION. APPROXIMATELY 4 YEARS AND 10 MONTHS LATER, THE PATIENT WAS BEING WORKUP FOR A FAILED VALVE. AS PER FOLLOW-UP WITH THE VCC, A TTE PERFORMED APPROXIMATELY 4 YEARS AND 7 MONTHS POST TAVR REVEALED EF 55-60%, MG 29MMHG, AVA 0.7, DI 0.2, PEAK VELOCITY 3.51M/S, LA SEVERELY DILATED, MILD MITRAL REGURGITATION. TWO WEEKS LATER AN ADDITIONAL TTE WAS PERFORMED WHICH REVEALED EF 50-55%, MG 30MMHG, PEAK VELOCITY 2.5M/S, AND LA MODERATELY DILATED. THE PATIENT THEN UNDERWENT A VALVE IN VALVE APPROXIMATELY 4 YEARS AND 10 MOTHS POST TAVR WITH A NON-EDWARDS VALVE INSIDE THE PRE-EXISTING 23MM SAPIEN 3 ULTRA VALVE IN AORTIC POSITION.

  Patient problems: Insufficient Information

  MAUDE report 25143045 ↗
• InjuryMay 11, 2026Degraded

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) APPROXIMATELY 5 YEARS, 3 MONTHS AND 9 DAYS POST TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 23MM SAPIEN 3 ULTRA VALVE THE VALVE FAILED WITH STENOSIS AND REGURGITATION. THIS WAS CONFIRMED BY INTRA PROCEDURAL ULTRASOUND IMAGING. A VALVE IN VALVE WAS DONE USING A 23MM SAPIEN 3 ULTRA RESILIA VALVE. THE VALVE WAS SUCCESSFULLY IMPLANTED AND THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 25134962 ↗
• DeathMay 6, 2026Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) THE PATIENT HAD A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 23MM SAPEIN 3 ULTRA RESILIA VALVE AND APPROXIMATELY 6 MONTHS AND 27 DAYS LATER THE PATIENT EXPIRED. THE PATIENT WAS ADMITTED ON 2 DAYS PRIOR TO PASSING WITH ACUTE ON CHRONIC HEART FAILURE WITH PRESERVED EJECTION FRACTION COMPLICATED BY ACUTE RESPIRATORY FAILURE AND PLEURAL EFFUSIONS. THE TRANSTHORACIC ECHOCARDIOGRAM (TTE) PERFORMED ONE DAY BEFORE THE PATIENT EXPIRED SHOWED SEVERE PROSTHETIC VALVE AORTIC STENOSIS, WITH AN AORTIC VALVE MEAN GRADIENT OF 85MMHG AND AORTIC VALVE AREA VTI OF 0.31 CM2. AFTER DISCUSSIONS INVOLVING FAMILY AND THE PATIENT'S POWER OF ATTORNEY (POA), CODE STATUS WAS CLARIFIED AS DO NOT RESUSCITATE/DO NOT INTUBATE. THE PATIENT WAS TRANSITIONED TO COMFORT-FOCUSED CARE AND ULTIMATELY PATIENT EXPIRED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 25092477 ↗
• InjuryMay 5, 2026Perivalvular Leak

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 3 YEARS POST TAVR PROCEDURE WITH A 23MM SAPIEN 3 VALVE, THE VALVE PRESENTED PARAVALVULAR LEAK. THE PATIENT UNDERWENT A VALVE IN VALVE PROCEDURE WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT WAS ADMITTED WITH PLEURITIC CHEST PAIN, SHORTNESS OF BREATH, DYSPNEA ON EXERTION, AND VOLUME OVERLOAD. PER ECHO REPORT, THE PROSTHETIC VALVE IS WELL SEATED WITH NORMAL GRADIENTS. THERE IS MODERATE LATERAL PARAVALVULAR REGURGITATION PRESENT. THE JET ORIGINATES WITHIN THE SAPIEN 3 FRAME JUST ABOVE THE PROSTHETIC LEAFLETS AND FLOWS LATERALLY OUT OF THE FRAME AND INTO THE LEFT VENTRICLE. THE PEAK GRADIENT MEASURES 24MMHG AND THE MEAN GRADIENT IS 9MMHG. THERE IS A DIMENSIONLESS VALVE INDEX OF 0.61. PER REPORT, AT INITIAL IMPLANT 3 YEARS AGO, THERE WAS TRACE PARAVALVULAR REGURGITATION WITH PEAK GRADIENTS AT 19MMHG AND MEAN GRADIENTS OF 12MMHG. A COMPLETE TRANSTHORACIC ECHOCARDIOGRAM WAS PERFORMED THE PROSTHETIC VALVE IS WELL-SEATED. THERE ARE NORMAL GRADIENTS ACROSS THE PROSTHETIC VALVE. THERE IS MODERATE PARAVALVULAR REGURGITATION PRESENT AT 3 O'CLOCK POSITION WITH INTRAVALVULAR EXTENSION. P

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 25085040 ↗
• InjuryMay 4, 2026Gradient Increase; Device Stenosis

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 6 YEARS POST-IMPLANT OF A 26 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH, THE VALVE FAILED DUE TO STENOSIS. A VALVE IN VALVE WAS SUCCESSFULLY PERFORMED WITH A 20 MM SAPIEN 3 ULTRA RESILIA AND POST-DILATED WITH 20 MM NON-EW BALLOON.

  Patient problems: Insufficient Information

  MAUDE report 25073499 ↗
• InjuryApr 29, 2026Insufficient Device Problem Information

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 8 MONTHS AND 7 DAYS POST-IMPLANT OF A 23 SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH. A VALVE IN VALVE WAS PERFORMED. THE FAILURE MODE IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25034623 ↗

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