SAPIEN 3 Ultra RESILIARecalls & reported problems across all models

We found 4 models of SAPIEN 3 Ultra RESILIA by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 881 adverse event reports in the FDA's MAUDE database, received between Nov 30, 2022 and Sep 3, 2026 — classified as 77 deaths, 682 injuries, 122 malfunctions.

The most frequently reported specific device problem is “Perivalvular Leak” (211 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 SAPIEN 3 Ultra RESILIA problems

SAPIEN 3 Ultra RESILIA models

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

• 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 RESILIA 9755RSL23

  Prosthesis, Mitral Valve, Percutaneously Delivered
  20 deaths202 reports
• SAPIEN 3 Ultra RESILIA 9755RSL20

  Prosthesis, Mitral Valve, Percutaneously Delivered
  4 deaths44 reports

Recent SAPIEN 3 Ultra RESILIA 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 ↗
• MalfunctionJul 27, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50000322 ↗
• 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 22, 2026Perivalvular Leak

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 1 YEAR AND 2 WEEKS POST TAVR WITH A 20MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION, THE PATIENT WAS TREATED VIA THV IN THV WITH ANOTHER 20MM SAPIEN ULTRA RESILIA VALVE DUE TO MODERATE PVL.

  Patient problems: Insufficient Information

  MAUDE report 25586547 ↗
• InjuryJun 18, 2026Insufficient Device Problem Information

  AS REPORTED BY IMPLANT PATIENT REGISTRY THROUGH RECEIPT OF AN IMPLANT DATA CARD, APPROXIMATELY 1 YEAR, 13 DAYS POST TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE WITH A 26MM SAPIEN 3 ULTRA RESILIA VALVE, THE PATIENT'S VALVE WAS EXPLANTED AND REPLACED WITH A SURGICAL VALVE. THE CAUSE OF THE EXPLANT IS UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 25547403 ↗
• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED IN THE ARTICLE, 'BUDDY WIRE TECHNIQUE FOR RESCUING AN EMBOLIZED TAVR VALVE', DURING A RIGHT TRANSFEMORAL TAVR PROCEDURE WITH A 29MM SAPIEN 3 ULTRA RESILIA VALVE, RAPID PACING AT 180 BEATS/MIN WAS INITIATED USING A TEMPORARY RIGHT VENTRICULAR PACEMAKER, AND THE VALVE WAS DEPLOYED. DURING DEPLOYMENT, THE PATIENT DEVELOPED PREMATURE VENTRICULAR CONTRACTIONS AND LOSS OF CAPTURE, LEADING TO EMBOLIZATION OF THE PARTIALLY DEPLOYED VALVE INTO THE ASCENDING AORTA. USING THE DELIVERY BALLOON, THE VALVE WAS RETRIEVED INTO THE DESCENDING AORTA; HOWEVER, A CORNER OF THE VALVE CAUGHT THE LESSER CURVATURE OF THE AORTA, CAUSING THE BALLOON TO SLIP THROUGH THE VALVE. TROUBLESHOOTING WAS DONE BUT WAS UNSUCCESSFUL. THE TEAM THEN USED A BUDDY WIRE TECHNIQUE WITH 2 WIRES IN A SINGLE CATHETER WHICH ENABLING PARTIAL EXPANSION OF THE EMBOLIZED VALVE AND FACILITATING COAXIAL REPOSITIONING WITHIN THE AORTA. POSITIONING WAS CONFIRMED WITH ANGIOGRAPHY, AND THE VALVE WAS BALLOONED FOR FURTHER EXPANSION IN THE ASCENDING AORTA, FOLLOWED BY FULL EXPANSION IN THE DESCENDING AORTA. THE PATIENT REMAINED HEMODYNAMICALLY STABLE. A SECOND 29MM SAPIEN 3 ULTRA RESILIA VALVE WAS THEN FULLY DEPLOYED ACROSS THE

  Patient problems: Foreign Body In Patient

  MAUDE report 25509227 ↗
• InjuryJun 15, 2026Perivalvular Leak

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), A PATIENT UNDERWENT A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE IN AORTIC POSITION. APPROXIMATELY 1 YEAR AND 8 MONTHS LATER, THE PATIENT UNDERWENT A VALVE IN VALVE (VIV) WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE INSIDE THE PRE-EXISTING 23MM SAPIEN 3 ULTRA RESILIA VALVE DUE TO PARAVALVULAR LEAK.

  Patient problems: Insufficient Information

  MAUDE report 25505831 ↗
• InjuryJun 12, 2026Device Stenosis; Unspecified Valve Regurgitation

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, A PATIENT WITH A 26MM SAPIEN 3 ULTRA RESILIA AORTIC VALVE IMPLANTED FOR 1 YEAR AND 6 MONTHS UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO STENOSIS AND REGURGITATION. CT TAVR AND TEE IMAGING CONFIRMED PANNUS FORMATION IN THE SUB-VALVULAR AREA. A 23MM SAPIEN 3 ULTRA RESILIA VALVE WAS SUCCESSFULLY IMPLANTED. PER THE MEDICAL RECORDS, A CARDIOLOGY PROGRESS NOTE DATED 5/13/2026 DOCUMENTED THAT ECHO FINDINGS FROM 10/27/2025 (APPROXIMATELY 1 YEAR POST TAVR) REVEALED NO PERIVALVULAR LEAK, MILD TRANSVALVULAR REGURGITATION AND AN AORTIC VALVE MEAN GRADIENT OF 23 MMHG. THE VALVE WAS DOCUMENTED TO HAVE NORMAL FUNCTION. THE OBSERVED CHANGE IN HEMODYNAMICS WAS ATTRIBUTED TO ATRIAL FIBRILLATION. A CT PERFORMED AT THAT TIME DEMONSTRATED MINIMAL LEAFLET HYPOATTENUATION WITHOUT ASSOCIATED MOTION RESTRICTION AND NO EVIDENCE OF THROMBUS. THE PATIENT WAS ALREADY ON ELIQUIS AND NO CHANGES TO THE MEDICATION REGIMEN WERE MADE. WHILE A REPEAT ECHO PERFORMED ON (B)(6) 2026 REVEALED WORSENING VALUES CONSISTENT WITH STENOSIS: MODERATE TRANSVALVULAR REGURGITATION, AORTIC VALVE PEAK VELOCITY OF 3.9 M/S, AN AORTIC VALVE MEAN GRADIENT OF 31 MMHG, A DI OF 0.27 AND AN AORT

  Patient problems: Insufficient Information

  MAUDE report 25488147 ↗
• InjuryJun 8, 2026Insufficient Device Problem Information

  AS REPORTED BY IMPLANT PATIENT REGISTRY, APPROXIMATELY 3 YEARS POST TAVR WITH A 29 MM SAPIEN 3 ULTRA RESILIA VALVE, THE VALVE WAS EXPLANTED DUE TO UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 25430748 ↗
• InjuryJun 5, 2026Migration or Expulsion of Device; Perivalvular Leak

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT A PATIENT UNDERWENT TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) IN A PREVIOUSLY IMPLANTED NON-EDWARDS ANNULOPLASTY RING VIA THE RIGHT JUGULAR VEIN APPROACH. AS REPORTED, THE FIRST 29MM SAPIEN 3 ULTRA RESILIA VALVE WAS PREPPED AND WAS UNABLE TO CROSS INTO THE RIGHT ATRIUM (RA) VIA TRANSFEMORAL (TF) APPROACH. THE S3UR VALVE WAS REMOVED. A SECOND 29MM SAPIEN 3 ULTRA RESILIA VALVE WAS PREPPED AND ADVANCED INTO THE TRICUSPID SURGICAL RING VIA THE RIGHT JUGULAR VEIN. THE VALVE WAS DEPLOYED 50/50. MODERATE PARAVALVULAR LEAK (PVL) WAS NOTED. A 28MM TRUE BALLOON WAS USED TO POST DILATE WITH X2 INFLATIONS. THE TAVR VALVE APPEARED TO MIGRATE TOWARDS THE RA AFTER SECOND INFLATION. THE PVL WAS NOW SEVERE. THE DECISION WAS MADE TO GO TO SURGERY. THE PATIENT'S VITALS WERE STABLE THE ENTIRE CASE. THE PATIENT LEFT THE PROCEDURE AREA WITH STABLE VITALS. THE INITIAL REPORTER DID NOT ALLEGE THAT ANY OF THE EW DEVICES WERE DEFICIENT IN SOME WAY.

  Patient problems: Insufficient Information

  MAUDE report 25410780 ↗
• InjuryJun 2, 2026Insufficient Device Problem Information

  IT WAS REPORTED VIA EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY, APPROXIMATELY 8 MONTHS POST IMPLANTATION OF A 26MM SAPIEN 3 ULTRA RESILIA VALVE IN THE MITRAL POSITION, THE VALVE WAS EXPLANTED. THE CAUSE OF THE EXPLANT AND PATIENT SYMPTOMS BEFORE EXPLANT WERE NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25364089 ↗
• InjuryJun 1, 2026Insufficient Device Problem Information

  AS REPORTED BY IMPLANT PATIENT REGISTRY APPROXIMATELY 3 MONTHS POST TAVR WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE IN A PRE-EXISTING EDWARDS SURGICAL VALVE, THE VALVE WAS EXPLANTED DUE TO UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 25350041 ↗
• InjuryMay 29, 2026Expulsion

  IT WAS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), THAT DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 23MM SAPIEN 3 VALVE, WHILE DELIVERING THE VALVE FOR IMPLANTATION, A PREMATURE VENTRICULAR CONTRACTION (PVC) BROKE THROUGH THE PACING RUN; WHICH RESULTED IN THE VALVE EMBOLIZING AND BEING IMPLANTED IN THE DESCENDING AORTA. A SECOND VALVE WAS PREPPED AND DEPLOYED TO SUCCESSFULLY COMPLETE THE PROCEDURE. POST PROCEDURE, THE PATIENT WAS REPORTED TO BE IN THE POST ANESTHESIA CARE UNIT (PACU) IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 25337685 ↗
• InjuryMay 27, 2026Calcified; Patient-Device Incompatibility

  AS REPORTED BY IMPLANT PATIENT REGISTRY, APPROXIMATELY 1 YEAR AND 9 MONTHS POST TRANSFEMORAL TAVR PROCEDURE WITH A 20 MM SAPIEN 3 ULTRA RESILIA VALVE, THE VALVE WAS EXPLANTED AND A SURGICAL VALVE WAS IMPLANTED. THE CAUSE OF THE EXPLANT IS DUE TO CALCIFICATION AND AORTIC VALVE PANNUS. ACCORDING TO THE MEDICAL RECORDS, A PRE-PROCEDURE TEE WAS PROVIDED THAT SHOWED AORTIC VALVE WITH TAVR IN PREVIOUSLY PLACED SURGICAL AORTIC VALVE REPLACEMENT (SAVR) WHICH APPEARED WELL-SEATED, MEAN GRADIENT OF 41MMHG, CALCIFICATION SEEN ON THE PROSTHETIC LEAFLET OF WHERE THE NATIVE RIGHT CORONARY CUSP (RCC) WOULD BE, NO PARAVALVULAR LEAK (PVL) OR AORTIC INSUFFICIENCY. THE PATIENT WENT FOR A TAVR EXPLANT OF THEIR SAPIEN 3 ULTRA RESILIA ON WHICH WAS REPLACED WITH A 23 MM NON-EW MECHANICAL VALVE. OTHER PROCEDURES PERFORMED AT THIS TIME INCLUDE REDO STERNOTOMY, AORTIC/LVOT PATCH ROOT ENLARGEMENT, PULMONIC ROOT RE-REPLACEMENT: 25 MM TISSUE CONDUIT, AND A LEFT CORONARY 6MM DACRON GRAFT. POST-OP TEE SHOWED THE AV WAS REPLACED BY A 23MM NON-EW MECHANICAL VALVE AND FINDINGS WERE CONSISTENT WITH A NORMAL FUNCTIONING PROSTHETIC VALVE. THE EXPLANTED TAVR VALVE WAS FOUND TO HAVE AORTIC VALVE PANNUS. THE TAVR EXPLANT

  Patient problems: Insufficient Information

  MAUDE report 25295979 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED FROM EDWARDS LIFESCIENCES PATIENT SUPPORT DEPARTMENT, REGARDING IMPLANTATION OF A 29MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION. CARE ADVOCATE CALLED AND STATED DURING THE TIME OF THE TAVR, THE PATIENT WAS ALSO IMPLANTED WITH A PACEMAKER. NO ADDITIONAL DETAILS OF THE PACEMAKER IMPLANATATION WAS PROVIDED.

  Patient problems: Heart Block

  MAUDE report 25280382 ↗

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