EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)Recalls & reported problems across all models

We found 4 models of EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 2,986 adverse event reports in the FDA's MAUDE database, received between Mar 26, 2019 and Jul 31, 2026 — classified as 97 deaths, 2,853 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Degraded” (692 reports).

1 FDA recall record name at least one of these models by its device identifier.

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

EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 11, 2018Class IITerminated

   SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.

   Z-2435-2018 · Root cause: Labeling False and Misleading · Recall details · FDA record ↗

Most reported EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) problems

EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) models

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

• EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) 9600TFX

  Prosthesis, Mitral Valve, Percutaneously Delivered
  59 deaths1,124 reports
• EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) 9600TFX

  Prosthesis, Mitral Valve, Percutaneously Delivered
  14 deaths975 reports
• EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) 9600TFX

  Prosthesis, Mitral Valve, Percutaneously Delivered
  1 recall22 deaths733 reports
• EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) 9600TFX

  Prosthesis, Mitral Valve, Percutaneously Delivered
  2 deaths154 reports

Recent EDWARDS SAPIEN 3 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.

• InjuryJul 31, 2026Degraded

  As reported by the Field Clinical Specialist (FCS), 7 years, 7 months, and 23 days post-implant of a 23 mm Sapien 3 valve in the aortic position, the 23 mm Sapien 3 valve required intervention due to stenosis, paravalvular leak (PVL), and increased gradients. The mean/ peak gradient was noted to be between 35-50mmHg and the AVA was between 0.5-1.0 cm2. The patient was experiencing dyspnea and heart failure. A valve in valve (VIV) procedure was completed with +2cc of volume successfully. Following the VIV, there was no PVL and the mean gradient was 5mmHg. The patient was in stable condition.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 50104767 ↗
• InjuryJul 27, 2026Degraded

  As reported by the Field Clinical Specialist (FCS), 6 years, 9 months, and 12 days post-implant of a 26 mm Sapien 3 valve in the aortic position, the 26 mm Sapien 3 valve required intervention due to stenosis, central regurgitation, and paravalvular leak (degeneration). The patient was experiencing heart failure. A valve in valve was completed successfully and the patient left the cath lab in stable condition.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 50036032 ↗
• InjuryJun 26, 2026Calcified

  IT WAS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), THAT APPROXIMATELY 6 YEARS, 7 MONTHS, 11 DAYS POST TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 26 MM SAPIEN 3 VALVE, THE PATIENT UNDERWENT A SUCCESSFUL VALVE IN VALVE (VIV) PROCEDURE WITH A 26 MM SAPIEN 3 ULTRA VALVE DUE TO STENOSIS, MILD LEAFLET CALCIFICATION, AND MILD HYPOATTENUATED LEAFLET THICKENING (HALT) AT THE BASE OF ALL THREE LEAFLETS.

  Patient problems: Insufficient Information

  MAUDE report 25637771 ↗
• InjuryJun 25, 2026Device Stenosis

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT DURING A PATIENT WITH A 23MM SAPIEN 3 VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT A VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS AND 6 MONTHS DUE TO STENOSIS. A 23MM SAPIEN 3 ULTRA VALVE WAS IMPLANTED SUCCESSFULLY. THERE WERE NO DEVICE OR PROCEDURAL COMPLICATIONS.

  Patient problems: Insufficient Information

  MAUDE report 25630863 ↗
• InjuryJun 25, 2026Perivalvular Leak

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 6 YEARS AND 11 MONTHS POST TRANSFEMORAL TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 23MM SAPIEN 3 VALVE, THE VALVE FAILED DUE TO A SEVERE PARAVALVULAR LEAK (PVL). THE SAPIEN VALVE WAS BALLOONED WITH A 26MM NON-EDWARDS DEVICE TO RELIEVE SOME OF THE PVL, BUT THIS WAS UNSUCCESSFUL. IN RESPONSE, A SECOND VALVE (26MM SAPIEN 3 ULTRA) WAS IMPLANTED SLIGHTLY DEEPER VIA VALVE-IN-VALVE PROCEDURE, AFTER WHICH THE PVL REDUCED TO A MILD DEGREE. ADDITIONAL INFORMATION PROVIDED PER VALVE CLINICAL COORDINATOR INDICATING THERE WAS MILD PVL AT INITIAL TAVR IMPLANT. THE PATIENT SINCE PRESENTED WITH SHORTNESS OF BREATH AND A MEAN GRADIENT OF 6MMHG. THE FINAL PATIENT OUTCOME OF THE PATIENT IS REPORTED AS STABLE UPON DISCHARGE. ACCORDING TO THE PROVIDED MEDICAL RECORDS, TRANSTHORACIC ECHOCARDIOGRAM (TTE) PERFORMED 4 DAYS PRIOR TO REVISION NOTED A 26MM BIOPROSTHETIC VALVE THAT APPEARS WELL SEATED WITH NO ROCKING OR ABERRANT MOTION. WHILE THERE IS NO INTRAVALVULAR REGURGITATION, THERE IS MODERATE PERIVALVULAR REGURGITATION, THE MEAN SYSTOLIC GRADIENT IS 6MMHG, PEAK GRADIENT IS 9MMHG AND THE VALVE AREA IS 2.6CM^2.

  Patient problems: Dyspnea

  MAUDE report 25630573 ↗
• InjuryJun 25, 2026Calcified

  AS REPORTED FROM THE PARTNER 3 TRIAL, APPROXIMATELY 9 YEARS POST-IMPLANT OF A 26MM SAPIEN 3 VALVE IN THE AORTIC POSITION, THE VALVE IS FAILING DUE TO CALCIFICATION, AND VALVE INTERVENTION IS PLANNED. THE PATIENT UNDERWENT SUCCESSFUL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 26MM SAPIEN S3 VALVE. APPROXIMATELY 7 MONTHS POST IMPLANT, VALVE-ASSOCIATED THROMBUS FORMATION WAS IDENTIFIED, PROMPTING INITIATION OF ANTICOAGULATION. APPROXIMATELY 7 YEARS AND 11 MONTHS POST-TAVR, THE PATIENT WAS ADMITTED DUE TO AN ISSUE UNRELATED TO THE VALVE. DURING THIS ADMISSION, A TRANSTHORACIC ECHOCARDIOGRAM (TTE) DEMONSTRATED A MEAN TRANSVALVULAR GRADIENT OF 28 MMHG AND AN AORTIC VALVE AREA (AVA) OF 1.63 CM2, WITH TRACE VALVULAR REGURGITATION AND NO PARAVALVULAR LEAK (PVL). NO IMMEDIATE INTERVENTION WAS PLANNED. APPROXIMATELY 8 YEARS AND 3 MONTHS POST-TAVR, THE PATIENT WAS BEING EVALUATED FOR PVL, BUT THE REGURGITATION WAS ONLY MILD TO MODERATE AND THERE WAS NO INDICATION FOR INTERVENTION. THE SURGEON'S INTERPRETATION OF THE ECHO DOCUMENTED MILD-TO-MODERATE PARAVALVULAR AORTIC REGURGITATION, ECCENTRIC AND DIRECTED TOWARDS THE ANTERIOR MITRAL LEAFLET. THE SURGEON ADDRESSED THE INCREASE IN GRAD

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 25628612 ↗
• InjuryJun 24, 2026Calcified

  AS REPORTED BY IMPLANT PATIENT REGISTRY, A PATIENT UNDERWENT EXPLANT OF THEIR 23MM SAPIEN 3 VALVE IN THE AORTIC POSITION APPROXIMATELY 9 YEARS AND 1.5 MONTHS POST TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE DEVICE WAS EXPLANTED AND REPLACED WITH AN EDWARDS SURGICAL VALVE. ACCORDING TO THE MEDICAL RECORD REVIEW, THE PATIENT WAS EXPERIENCING SEVERE EXERTIONAL SHORTNESS OF BREATH, LETHARGY, DIZZINESS, LIGHTHEADEDNESS AND BILATERAL LOWER EXTREMITY EDEMA. AN OPERATIVE REPORT WAS NOT PROVIDED, HOWEVER A POST OPERATIVE FOLLOW UP NOTE INDICATED THAT THE PATIENT UNDERWENT TAVR EXPLANT, AORTIC ROOT REPLACEMENT, PULMONARY VEIN ISOLATION (PVI) AND LEFT ATRIAL APPENDAGE LIGATION. THE PATIENT WAS NOTED TO BE A POOR VALVE IN VALVE CANDIDATE DUE TO ANATOMY AND RISK FOR CORONARY ARTERY OBSTRUCTION. THE CONSULTATION NOTES INDICATED THAT THE PATIENT HAD SEVERE STENOSIS WITH KNOWN PATIENT PROSTHETIC MISMATCH. A CTA TAVR NOTED THE VALVE IS GROSSLY INTACT, THERE IS MILD HALT OF ALL 3 LEAFLETS, NO PERIVALVULAR LEAK. A TEE PERFORMED APPROXIMATELY 9 YEARS AND 1 MONTH POST IMPLANT NOTED A TAVR VALVE WITHOUT SIGNIFICANT STENOSIS AND NORMAL LEAFLET OPENING. THE PATHOLOGY REPORT NOTED A MEDICA

  Patient problems: Dyspnea

  MAUDE report 25609737 ↗
• InjuryJun 22, 2026Gradient Increase

  THE FIELD CLINICAL SPECIALIST (FCS), CALLED INTO THE THV HOTLINE TO REPORT THE PATIENT'S BAV PROCEDURE PERFORMED TO ADDRESS POTENTIAL INCREASED GRADIENTS. THE TRANSTHORACIC ECHOCARDIOGRAM (TTE) INDICATED ELEVATED GRADIENTS; HOWEVER, ACCURATE MEASUREMENTS COULD NOT BE OBTAINED. THE PHYSICIAN PERFORMED A POST-DILATION OF THE PREVIOUSLY IMPLANTED 23 MM SAPIEN 3 VALVE APPROXIMATELY 9 YEARS AND 3 MONTHS POST TAVR. NO PATIENT SYMPTOMS WERE REPORTED, AND THE PATIENT WAS NOTED TO BE DOING WELL POST-PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 25584480 ↗
• InjuryJun 22, 2026Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 5 YEARS AND 9 MONTHS POST TRANSFEMORAL TAVR PROCEDURE WITH A 29MM SAPIEN 3 VALVE IN THE AORTIC POSITION, THE PATIENT UNDERWENT A VIV DUE TO STENOSIS. THE PROCEDURE WAS A SUCCESSFUL VIV WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND WAS TAKEN TO RECOVERY POST PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 25578911 ↗
• InjuryJun 22, 2026Calcified

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) APPROXIMATELY 5 YEARS, 9 MONTHS, AND 22 DAYS POST TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT WITH A 23MM SPAIEN 3 VALVE THE VALVE HAD TO BE EXPLANTED DUE TO STRUCTURAL VALVE DETERIORATION AND A SURGICAL VALVE WAS IMPLANTED. THE PATIENT PRESENTED WITH DYSPNEA AND FATIGUE. THE PATIENT HAD A PEAK GRADIENT OF 124 AND A MEAN GRADIENT OF 82, THE VALVE INDEX AREA WAS 0.64. THE LEAFLETS WERE FOUND TO BE THICKENED; THE LEFT CORONARY CUSP WAS MILDLY RESTRICTED AND THE OTHER 2 LEAFLETS WERE SIGNIFICANTLY RESTRICTED. THE PATIENT IS STILL IN THE HOSPITAL POST EXPLANT. PER MEDICAL RECORDS THE PATIENT PRESENTED WITH SEVERE STENOSIS AND PERIVALVULAR INSUFFICIENCY. UNDER GENERAL ANESTHESIA, THE PATIENT HAD TAVR EXPLANT AND AVR. PER IMAGERY REVIEW BY EDWARDS IMAGER THE VALVE LEAFLETS APPEAR SOMEWHAT THICKENED AND MARKEDLY ELEVATED CALCIUM BURDEN, PARTICULARLY INVOLVING TWO OF THE PROSTHETIC LEAFLETS, WITH FEATURES CONSISTENT WITH CALCIFIED NODULES.

  Patient problems: Dyspnea

  MAUDE report 25577039 ↗
• InjuryJun 18, 2026Calcified

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, APPROXIMATELY 7 YEARS AND 5 MONTHS POST IMPLANTATION OF A 26MM SAPIEN 3 VALVE IN THE AORTIC POSITION, CALCIFICATION AND STENOSIS WERE OBSERVED. A VALVE IN VALVE WAS PERFORMED. PATIENT SYMPTOMS BEFORE THE VALVE IN VALVE WAS NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25549289 ↗
• InjuryJun 15, 2026Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 7 YEARS AND 8 MONTHS POST TAVR WITH A 23MM SAPIEN 3 VALVE IN THE MITRAL POSITION, THE PATIENT UNDERWENT A VIV DUE TO STENOSIS. A 23MM SAPIEN 3 ULTRA RESILIA VALVE WAS IMPLANTED WITHIN THE EXISTING THV. CATH GRADIENT POST IMPLANT WAS 2MMHG AND ECHO GRADIENT WAS 5MMHG.

  Patient problems: Insufficient Information

  MAUDE report 25506750 ↗
• InjuryJun 11, 2026Degraded; Insufficient Device Problem Information

  AS REPORTED BY THE IMPLANT PATIENT REGISTRY TEAM, APPROXIMATELY (B)(6) POST SUCCESSFUL TRANSFEMORAL AORTIC VALVE REPLACEMENT WITH A 26MM SAPIEN 3 VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A 25MM SURGICAL HEART VALVE. THE REASON FOR EXPLANT IS UNKNOWN AT THIS TIME.

  Patient problems: Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 25478310 ↗
• InjuryJun 11, 2026Calcified

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 5 YEARS AND 4 MONTHS FOLLOWING INITIAL IMPLANT OF A 29 MM SAPIEN 3 VALVE VIA TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR), THE PATIENT PRESENTED WITH DYSPNEA, FATIGUE, AND HEART FAILURE. AN ECHOCARDIOGRAM NOTED MODERATE TO SEVERE AORTIC VALVE STENOSIS, PEAK VELOCITY 4.2 M/S, A MEAN GRADIENT OF 39 MMHG, AND A VALVE AREA OF 0.8 CM2. A VALVE IN VALVE PROCEDURE WAS PERFORMED DUE TO STENOSIS AND CALCIFICATION OF THE VALVE AND A 26 MM SAPIEN 3 ULTRA VALVE WAS SUCCESSFULLY IMPLANTED.

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

  MAUDE report 25473908 ↗
• InjuryJun 11, 2026Calcified

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) APPROXIMATELY 6 YEARS AND 3 MONTHS POST TRANSCATHETER AORTIC VALVE REPLACEMENT WITH A 23MM SAPIEN 3 VALVE THE VALVE FAILED DUE TO STENOSIS. THE MEAN VALVE GRADIENT WAS 55MMHG. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME. THE PATIENT PRESENTED WITH DIZZINESS. MEDICAL RECORDS WERE RECEIVED AND REVIEWED BY AN EDWARDS CLINICIAN; THE CT REVEALED THERE WERE CALCIFIED AORTIC VALVE LEAFLETS. THE STRUCTURAL HEART CARDIOLOGY NOTE STATED THAT THE PLAN WAS TO SEND TO ''VENDORS'' TO REVIEW RISK FOR VALVE IN VALVE TAVR AND POTENTIAL NEED FOR LEAFLET MODIFICATION AT TIME OF TAVR. THE VALVE IN VALVE PROCEDURE IS TO BE SCHEDULED FOR (B)(6) 2026.

  Patient problems: Dizziness

  MAUDE report 25470508 ↗

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