Edwards SAPIEN 3Recalls & reported problems across all models

We found 15 models of Edwards SAPIEN 3 by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 6,905 adverse event reports in the FDA's MAUDE database, received between Mar 26, 2019 and Sep 3, 2026 — classified as 339 deaths, 5,682 injuries, 884 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1,283 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 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, 2018Terminated

   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 problems

Edwards SAPIEN 3 models

15 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 Ultra Transcatheter Heart Valve 9750TFX26

  Prosthesis, Mitral Valve, Percutaneously Delivered
  64 deaths1,070 reports
• EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) 9600TFX

  Prosthesis, Mitral Valve, Percutaneously Delivered
  14 deaths975 reports
• Edwards SAPIEN 3 Ultra Transcatheter Heart Valve 9750TFX23

  Prosthesis, Mitral Valve, Percutaneously Delivered
  42 deaths936 reports
• EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) 9600TFX

  Prosthesis, Mitral Valve, Percutaneously Delivered
  1 recall22 deaths733 reports
• SAPIEN 3 Ultra System 9750CM26

  Prosthesis, Mitral Valve, Percutaneously Delivered
  26 deaths531 reports
• SAPIEN 3 Ultra RESILIA 9755RSL29

  Prosthesis, Mitral Valve, Percutaneously Delivered
  35 deaths321 reports
• SAPIEN 3 Ultra RESILIA 9755RSL26

  Prosthesis, Mitral Valve, Percutaneously Delivered
  18 deaths314 reports
• SAPIEN 3 Ultra System 9750CM23

  Prosthesis, Mitral Valve, Percutaneously Delivered
  22 deaths290 reports
• SAPIEN 3 Ultra RESILIA 9755RSL23

  Prosthesis, Mitral Valve, Percutaneously Delivered
  20 deaths202 reports
• EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) 9600TFX

  Prosthesis, Mitral Valve, Percutaneously Delivered
  2 deaths154 reports
• Edwards SAPIEN 3 Ultra Transcatheter Heart Valve 9750TFX20

  Prosthesis, Mitral Valve, Percutaneously Delivered
  9 deaths141 reports
• SAPIEN 3 Ultra System 9750CM20

  Prosthesis, Mitral Valve, Percutaneously Delivered
  2 deaths55 reports
• SAPIEN 3 Ultra RESILIA 9755RSL20

  Prosthesis, Mitral Valve, Percutaneously Delivered
  4 deaths44 reports
• EDWARDS SAPIEN 3 PULMONIC DELIVERY SYSTEM (29MM) 9630PL29A

  Pulmonary Valve Prosthesis Percutaneously Delivered
  15 reports

Recent Edwards SAPIEN 3 adverse event reports

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

• InjurySep 3, 2026Perivalvular Leak

  As reported by the Field Clinical Specialist (FCS), during off label implant of a 29 mm Sapien 3 Ultra Resilia valve in the MAC position, the team started with a 16f eSheath+ in the right femoral vein. There was a problem crossing the septum when the 29mm Commander Delivery System (DS) with the valve were inserted. The team decided to pull the DS and 16f eSheath+ as one unit. The first valve was wasted. Another 29mm DS and 29mm Sapien 3 Ultra Resilia were prepped. This time though, the team decided to use a 26f Gore Dry Seal Sheath to deliver the valve. It was able to successfully cross the septum with valve. The valve was deployed with nominal volume. Post dilatation was performed with +3cc. The team decided to do another post dilation but the DS was not able to go through the Gore Dry Seal Sheath, so another 29mm DS was prepped for post dilatation with +5cc. The operator also asked to attach an Atrion inflation device to the System for Pressure Monitoring. The post dilatation was successful with Mild-Moderate PVL remaining. The 29mm DS was removed from the patient and they were stable after the case.An update from the FCS noted that 2 days post implant, the patient had a valve in

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 50590787 ↗
• MalfunctionSep 2, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50564735 ↗
• 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 ↗
• 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 ↗
• MalfunctionJul 27, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50000322 ↗
• 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, 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 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 25, 2026Perivalvular Leak; Intravalvular regurgitation

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 1 YEAR AND 10 MONTHS POST-IMPLANT OF A 26 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH, THE PATIENT IS EXPERIENCING HEMOLYTIC ANEMIA DUE TO MODERATE PARAVALVULAR LEAK (PVL) AND MILD CENTRAL AORTIC INSUFFICIENCY (AI). ACCORDING TO THE MEDICAL RECORDS, PATIENT WAS EXPERIENCING DIZZINESS AND CHEST PAIN AND WAS CONFIRMED TO HAVE HEMOLYSIS DUE TO TAVR VALVE PVL BY HEMATOLOGY. PATIENT'S HEMOGLOBIN DROPPED TO 11 AND IMPROVED TO 14 WITH IRON SUPPLEMENTATION AND DID NOT REQUIRE ANY BLOOD TRANSFUSION. TEE SHOWED THE PROSTHESIS APPEARS TO BE WELL-SEATED, EF 50%, MEAN GRADIENT 15MMHG, LEAFLETS DEMONSTRATE NORMAL THICKNESS, AND BOTH PARAVALVULAR AND INTRAVALVULAR REGURGITANT JETS. CARDIOTHORACIC SURGERY EVALUATED THE PATIENT AND PATIENT MEETS CRITERIA FOR OPERATIVE INTERVENTION DUE TO PVL WITH HEMOLYSIS AND WILL BE SCHEDULED FOR AN AORTIC VALVE REPLACEMENT PENDING THE RESULTS OF THEIR CORONARY ANGIOGRAM. THE PLAN IS FOR AN AORTIC VALVE REPLACEMENT (AVR) WITH POSSIBLE CABG. PER IMAGING REVIEW, THE VALVE IS EXPANDED TO 100% OF NOMINAL AT THE MID-VALVE LEVEL, WITH NO LEAFLET CALCIFICATION. NO EVIDEN

  Patient problems: Dizziness; Hemolytic Anemia

  MAUDE report 25627067 ↗
• 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 ↗

Other Edwards Lifesciences LLC products

• EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)4 models · 2,986 reports · 1 recall
• Edwards SAPIEN 3 Ultra Transcatheter Heart Valve3 models · 2,147 reports
• 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