SAPIEN 3 Ultra RESILIA 9755RSL26Recalls & reported problems

Summary

The FDA's MAUDE database contains 314 adverse event reports that list this exact device (DI 00690103215816), received between Nov 30, 2022 and Jun 25, 2026 — classified as 18 deaths, 242 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (74 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 314 reports, in the reporter's own words as published by the FDA.

• 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 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 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 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 ↗
• InjuryMay 21, 2026Migration or Expulsion of Device; Perivalvular Leak

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT A PATIENT UNDERWENT OFF LABEL RIGHT TRANSFEMORAL TMVR WITH A 26MM S3UR, 26MM COMMANDER, AND NON-EDWARDS SHEATH. AS REPORTED, THE PATIENT HAD SEVERE DEGREE OF MITRAL ANNULAR CALCIFICATION. THE FIRST INFLATION DEPLOYED THE VALVE AT APPROXIMATELY A 90/10 POSITION. DURING INFLATION, THE VALVE BEGAN TO MIGRATE ATRIALLY (80/20), AND PARAVALVULAR LEAK (PVL) WAS NOTED. TO PREVENT FURTHER MIGRATION, AN ADDITIONAL 2CC WAS ADDED TO THE COMMANDER DELIVERY SYSTEM (DS) FOR A SECOND DEPLOYMENT ATTEMPT. HOWEVER, THE ADDITIONAL 2 CC COULD NOT BE TRANSFERRED INTO THE BALLOON. A THIRD ATTEMPT WAS MADE TO POST DILATE, BUT AGAIN THE BALLOON COULD NOT BE FULLY FILLED WITH CONTRAST, AND COMPLETE INFLATION COULD NOT BE ACHIEVED. AT THIS POINT, A SECOND COMMANDER DS WAS PREPARED WITH A TOTAL OF 28 CC OF 15% CONTRAST USING THE SAME ATRION SYRINGE AND CONTRAST MIXTURE AS THE INITIAL COMMANDER DS. DUE TO THE PERSISTENT PVL, THE TEAM DECIDED TO IMPLANT A SECOND 26 MM VALVE. THE SECOND VALVE WAS DEPLOYED SUCCESSFULLY, RESULTING IN RESOLUTION OF THE ISSUE. THE PATIENT'S FINAL OUTCOME WAS NOTED AS STABLE CONDITION. PER THE FIELD CLINICAL SPECIALI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25249919 ↗
• InjuryMay 20, 2026Fluid/Blood Leak; Migration

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, DURING IMPLANTATION OF A 26MM SAPIEN 3 ULTRA RESILIA VALVE IN THE MITRAL POSITION. DURING INFLATION, THE 26MM SAPIEN 3 ULTRA RESILIA VALVE BEGAN TO MIGRATE ATRIAL, AND PARAVALVULAR LEAK WAS NOTED. TO PREVENT FURTHER MIGRATION, AN ADDITIONAL 2 CC WAS ADDED TO THE 26MM COMMANDER DELIVERY SYSTEM FOR A SECOND DEPLOYMENT ATTEMPT. HOWEVER, THE ADDITIONAL 2 CC COULD NOT BE TRANSFERRED INTO THE DELIVERY SYSTEM BALLOON. A THIRD ATTEMPT WAS MADE TO POST DILATE, BUT AGAIN THE BALLOON COULD NOT BE FULLY FILLED WITH CONTRAST, AND COMPLETE INFLATION COULD NOT BE ACHIEVED. AT THIS POINT, A SECOND 26MM COMMANDER DELIVERY SYSTEM WAS PREPARED WITH A TOTAL OF 28 CC OF 15 PERCENT CONTRAST USING THE SAME ATRION SYRINGE AND CONTRAST MIXTURE AS THE FIRST 26MM COMMANDER DELIVERY SYSTEM. DUE TO THE PERSISTENT PVL, THE TEAM DECIDED TO IMPLANT A SECOND 26 MM SAPIEN 3 ULTRA RESILIA VALVE. THE SECOND VALVE WAS DEPLOYED SUCCESSFULLY, RESULTING IN RESOLUTION OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25235799 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY IMPLANT PATIENT REGISTRY, APPROXIMATELY 2 YEARS AND 4 MONTHS POST TAVR WITH A 26 MM SAPIEN 3 ULTRA RESILIA VALVE, THE VALVE WAS EXPLANTED DUE TO UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 25233163 ↗
• InjuryMay 18, 2026Perivalvular Leak; Malposition of Device

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), 1 YEAR, 3 MONTHS, AND 7 DAYS POST-IMPLANT OF A 26 MM SAPIEN 3 ULTRA RESILIA (S3UR) VALVE IN THE AORTIC POSITION, THE 26 MM SAPIEN 3 ULTRA RESILIA VALVE REQUIRED INTERVENTION DUE TO PARAVALVULAR LEAK (PVL) WHICH WAS SUSPECTED TO BE CAUSED BY UNDER EXPANSION OF THE VALVE. IT WAS ALSO SUSPECTED THAT THE VALVE WAS IMPLANTED SLIGHTLY HIGHER THAN THE NATIVE ANNULUS. A NEW 26MM S3UR WAS IMPLANTED AT 80/20 IN RELATION TO THE INITIAL 26MM S3UR. THE VALVE WAS DEPLOYED WITH NOMINAL VOLUME (23CC) AND POST DILATED WITH A 26MM TRUE BALLOON. THE PATIENT WAS IN STABLE CONDITION AFTER THE PROCEDURE. THE PATIENT DEVELOPED ANEMIA AFTER THEIR VALVE IMPLANT AND WAS REFERRED TO HEMATOLOGY. THE PATIENT NOTED THEY HAVE BEEN TIRED. RECENTLY THEIR HEMOGLOBIN DROPPED EVEN FURTHER WITH AN ELEVATED LDH, RETICULOCYTE COUNT, AND A LOW HAPTOGLOBIN, ALL CONSISTENT WITH HEMOLYSIS. THE PATIENT WAS HOSPITALIZED (B)(6) 2026 AND HAD A TRANSTHORACIC ECHOCARDIOGRAM THAT WAS PERFORMED AT THE END OF (B)(6) 2026, WHICH SHOWED MODERATE-TO-SEVERE PARAVALVULAR INSUFFICIENCY.

  Patient problems: Hemolytic Anemia

  MAUDE report 25209514 ↗
• InjuryMay 14, 2026Perivalvular Leak

  AS REPORTED THROUGH EDWARDS PATIENT SUPPORT, APPROXIMATELY 1 YEAR POST TRANSFEMORAL TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 26MM SAPIEN 3 ULTRA RESILIA VALVE IN THE NATIVE AORTIC POSITION, THE PATIENT PRESENTED AT FOLLOW-UP WITH A ''MODERATE LEAKAGE AROUND THE PERIMETER OF HIS VALVE'' AS DETECTED PER ECHOCARDIOGRAPHY (ECHO), CHARACTERIZED AS A PARAVALVULAR LEAK (PVL). THERE WERE DISCUSSIONS OF POSSIBLY NEEDING A ''PLUG'' PROCEDURE. THE PATIENT HAS BEEN SCHEDULED FOR A FOLLOW-UP ECHO NEXT MONTH. ACCORDING TO THE PROVIDED MEDICAL RECORDS, THE RIGHT TRANSFEMORAL TRANSCATHETER HEART VALVE IMPLANT WAS SUCCESSFUL WITH TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) CONFIRMED ABSENCE OF SIGNIFICANT PVL AND A POST IMPLANT GRADIENT OF 6MMHG, AS NOTED PER TAVR OPERATIVE NOTE. APPROXIMATELY 2 MONTHS LATER, TRANSTHORACIC ECHOCARDIOGRAM (TTE) REVEALED THE FOLLOWING: BIOPROSTHETIC AORTIC VALVE IN PLACE AND WELL SEATED, NO CENTRAL REGURGITATION, MODERATE PVL IS PRESENT WITH 2 JETS NOTED, AORTIC VALVE (AV) PEAK/MEAN GRADIENT OF 27/14MMHG, AND EFFECTIVE ORIFICE AREA (EOA) OF 1.9CM^2. NO TREATMENT OR INTERVENTION FOR PVL WERE MENTIONED IN THE RECORDS. ADDITIONAL INFORMATION PROVIDED PER

  Patient problems: Insufficient Information

  MAUDE report 25178439 ↗
• InjuryMay 11, 2026Fluid/Blood Leak

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, APPROXIMATELY 7 MONTHS POST IMPLANATION OF A 26MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION, VALVE APPEARED LOW. PATIENT PRESENTED WITH MODERATE PVL LEAK. A VALVE IN VALVE WAS PERFORMED WITH A 26MM SAPIEN 3 ULTRA RESILIA VALVE WITH AN ADDITIONAL 3ML. PVL LEAK POST IMPLANT WAS NOW MILD. PER THE FIELD CLINICAL SPECIALIST, THE 1ST VALVE WAS IMPLANTED LOW (90:10) AND PVL WAS CAUSING HEMOLYSIS.

  Patient problems: Hemolysis

  MAUDE report 25137986 ↗
• MalfunctionMay 8, 2026Material Deformation

  IT WAS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), THAT DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 26 MM SAPIEN 3 ULTRA RESILIA (S3UR) VALVE, THERE WAS DIFFICULTY ADVANCING THE DELIVERY SYSTEM THROUGH THE ESHEATH+. THE RIGHT ACCESS VESSELS WERE CALCIFIED AND WERE NARROWING IN THE TORTUOSITY BEND REGION; HIGH FORCE PUSHES WERE EXPERIENCED NEAR THE ILIAC. THE PHYSICIAN WAS ABLE TO SLIDE THE ESHEATH+ BACKWARDS, SLIGHTLY AWAY FROM THE TORTUOSITY, AND THEN ADVANCE THE VALVE THROUGH THE END OF THE SYSTEM. DURING EXIT OF THE VALVE THROUGH THE ESHEATH, ONE OF THE INFLOW STRUTS WAS BENT BACKWARDS. THE DECISION WAS MADE TO CONTINUE WITH VALVE IMPLANTATION AND THE 26 MM S3UR WAS DEPLOYED WITH NOMINAL VOLUME. AFTER VALVE DEPLOYMENT, DELIVERY SYSTEM WAS WITHDRAWN THROUGH SHEATH. UPON ESHEATH+ REMOVAL, A LINER TEAR WAS NOTED. TO VERIFY THAT THERE WERE NO INJURIES TO THE RIGHT ILIAC DURING THE PROCEDURE, A CONTRAST RUNOFF SHOT WAS TAKEN AND CONFIRMED NO PATIENT INJURY. AT THE END OF THE PROCEDURE, THE PATIENT WAS IN STABLE CONDITION. THE PERCEIVED ROOT CAUSE REPORTED WAS THAT THE RIGHT ACCESS VESSEL WAS CALCIFIED AND NARROWED INTO A TORTUOUS BEND REG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25128587 ↗
• MalfunctionMay 8, 2026Material Deformation

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, DURING A RIGHT TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE TO IMPLANT A 26 MM SAPIEN 3 ULTRA RESILIA VALVE (S3UR), THERE WAS DIFFICULTY ADVANCING THE VALVE THROUGH THE 14F ESHEATH+ AND THE VALVE HAD A BENT STRUT. IT WAS NOTED THAT THE RIGHT SIDE ACCESS VESSELS WERE CALCIFIED AND TORTUOUS. THERE WAS SLIGHT DIFFICULTY INSERTING THE ESHEATH+ INTO THE PATIENT DUE TO TORTUOSITY. THE ESHEATH+ WAS NOT INSERTED AT A STEEP ANGLE. THE VESSEL WAS DILATED WITH A 16F KIT DILATOR AND THE 14F ESHEATH+ AND DILATOR WERE INSERTED THROUGH. THE ESHEATH+ WAS ALSO EXPANDED WITH THE 16F DILATOR. HIGH PUSH FORCES WERE EXPERIENCED NEAR THE ILIAC, WHEN THE SYSTEM WAS IN THE FULLY EXPANDABLE PORTION OF THE ESHEATH+. THE OPERATOR WAS ABLE TO SLIDE THE ESHEATH+ BACK SLIGHTLY AWAY FROM THE TORTUOSITY AND THEN ADVANCE THE VALVE THROUGH. IT WAS NOTED THAT THE S3UR VALVE HAD ONE INFLOW STRUT BENT BACKWARDS. THE S3UR VALVE WAS DEPLOYED WITH NOMINAL VOLUME. THE STRUT REMAINED IN THE BENT POSITION AFTER DEPLOYMENT. A CONTRAST RUNOFF SHOT WAS TAKEN TO VERIFY THERE WERE NO INJURIES IN THE RIGHT ILIAC. THE PATIENT WAS IN STABLE CONDITION. UPON REMOVAL OF TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125251 ↗
• InjuryApr 28, 2026Perivalvular Leak

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), 2 YEARS, 1 MONTH, AND 17 DAYS POST-IMPLANT OF A 26 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION, THE 26 MM SAPIEN 3 ULTRA RESILIA VALVE WAS NOTED TO HAVE MODERATE PARAVALVULAR LEAK (PVL). THE OPERATOR DECIDED TO POST DILATE THE ALREADY EXISTING VALVE, WHICH THE ACCOUNT NOTED "HAS RECOILED". DURING INFLATION OF THE COMMANDER DELIVERY SYSTEM WITH +1CC OF EXTRA VOLUME, THE BALLOON RUPTURED RADIALLY AND UMBRELLAED OVER THE NOSE CONE WHILE PULLING BACK INTO THE ESHEATH+. THE DELIVERY SYSTEM WAS IMMEDIATELY BROUGHT BACK INTO THE ESHEATH+ AND REMOVED AS A UNIT. THE ESHEATH+ TIP COULD NOT BE REMOVED THROUGH THE ARTERIOTOMY, SO A VASCULAR CUTDOWN WAS NEEDED. THE POST DILATION WAS UNSUCCESSFUL AND ABORTED AFTER THE BALLOON BURST. THE PATIENT RECEIVED A 6X6MM DUCT OCCLUDER TO PLUG THE PVL. THE PATIENT LEFT THE ROOM IN STABLE CONDITION. PER IMAGERY REVIEW BY EDWARDS ENGINEER, A POSSIBLE LINER DELAMINATION WAS NOTED ON THE 14F ESHEATH+.

  Patient problems: Insufficient Information

  MAUDE report 25019084 ↗
• MalfunctionApr 21, 2026Material Deformation

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 26 MM SAPIEN 3 ULTRA RESILIA VALVE, ONE OF THE VALVE STRUTS WAS BENT WHILE THE COMMANDER DELIVERY SYSTEM WITH VALVE WAS BEING ADVANCED THROUGH THE 14FR ESHEATH+. THERE WAS DIFFICULTY ADVANCING THE DELIVERY SYSTEM WITH VALVE THROUGH THE ESHEATH+ AND IT APPEARED TO HAVE OCCURRED AT THE TRANSITION FROM THE STRAIN RELIEF TO THE SHEATH SHAFT/FULLY EXPANDABLE PORTION OF THE ESHEATH+. ONCE THE DELIVERY SYSTEM WITH VALVE EXITED THE ESHEATH+, THE BENT VALVE STRUT WAS NOTED. THE VALVE WAS DEPLOYED SUCCESSFULLY. THE DELIVERY SYSTEM WAS REMOVED THROUGH THE ESHEATH+ AND THEN THE ESHEATH+ WAS REMOVED. THE DELIVERY SYSTEM AND ESHEATH+ WERE INTACT WITH NO DAMAGE OBSERVED. THERE WAS NO PATIENT INJURY. IMAGERY WAS RECEIVED FOR EVALUATION. PER IMAGING EVALUATION, ONE (1) BENT STRUT WAS LOCATED AT THE INFLOW SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941728 ↗
• InjuryApr 20, 2026Malposition of Device

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, REGARDING A 26MM SAPIEN 3 ULTRA RESILIA VALVE IN A PRE-EXISTING SURGICAL VALVE THE PULMONIC POSITION. DURING VALVE DEPLOYMENT WITHIN THE EXISTING SURGICAL VALVE, THE 26MM SAPIEN 3 ULTRA RESILIA VALVE WAS DEPLOYED TOO DISTAL. NOT ABLE TO BE PULLED BACK MORE PROXIMALLY DURING DEPLOYMENT BY THE IMPLANTING PHYSICIAN DUE TO AN ACUTE ANGLE AND PATIENT ANATOMY. WITH THE POSSIBLE RISK OF EMBOLIZATION, THE WIRE WAS KEPT IN TO HELP HOLD THE VALVE IN PLACE AND A PALMAZ STENT WAS THEN PLACED IN A TELESCOPING MANNER INSIDE THE VALVE AND THE OLD SURGICAL VALVE TO PIN THE VALVE IN PLACE, CREATING ONE LONG STENT COMPLEX. AFTER THE VALVE WAS SECURED IN A SAFE MANNER WITH THIS METHOD, A NON EDWARDS VALVE WAS THEN IMPLANTED SUCCESSFULLY WITHIN THE STENT COMPLEX. THE PATIENT WAS STABLE FOR THE ENTIRE DURATION OF THE PROCEDURE WITH NO VASCULAR INJURY NOTED.

  Patient problems: Insufficient Information

  MAUDE report 24927250 ↗
• InjuryApr 10, 2026Insufficient Device Problem Information

  AS REPORTED THROUGH EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY (IPR), APPROXIMATELY 1 YEARS AND 6 MONTHS POST TRANSFEMORAL TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 26 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE NATIVE AORTIC POSITION, THE VALVE WAS EXPLANTED DUE TO AN UNKNOWN CAUSE. A 23 MM SURGICAL VALVE WAS IMPLANTED IN THE AORTIC POSITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24839850 ↗
• InjuryApr 6, 2026Insufficient Device Problem Information

  IT WAS REPORTED VIA THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY, APPROXIMATELY 11 MONTHS POST IMPLANTATION OF A 26MM SAPIEN 3 ULTRA RESILIA VALVE IN THE TRICUSPID POSITION, THE VALVE WAS EXPLANTED. THE CAUSE OF THE EXPLANT AND PATIENT SYMPTOMS BEFORE THE EXPLANT WERE NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24794354 ↗
• InjuryApr 6, 2026Insufficient Device Problem Information

  IT WAS REPORTED VIA THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY, APPROXIMATELY 1 YEAR AND 7 MONTHS POST IMPLANTATION OF A 26MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSISTION, THE VALVE WAS EXPLANTED. THE CAUSE OF THE EXPLANT AND PATIENT SYMPTOMS BEFORE THE EXPLANT WAS NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24794351 ↗
• InjuryApr 3, 2026Insufficient Device Problem Information

  AS REPORTED BY IMPLANT PATIENT REGISTRY THROUGH RECEIPT OF AN IMPLANT DATA CARD, APPROXIMATELY 5 AND A HALF MONTHS POST TRANSFEMORAL TAVR PROCEDURE WITH A 26 MM 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 24775248 ↗
• InjuryMar 30, 2026Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 2 YEARS POST TRANSFEMORAL TMVR PROCEDURE WITH A 26 MM SAPIEN 3 ULTRA RESILIA VALVE, THE VALVE FAILED DUE TO FROZEN LEAFLETS. PER FEEDBACK FROM THE VALVE CLINIC COORDINATOR, THE PATIENT RECENTLY UNDERWENT A TAVR TO ADDRESS THE AORTIC VALVE. THEY WILL REASSESS TO SEE IF A MITRAL VALVE INTERVENTION NEEDS TO BE ADDRESSED IN THE FUTURE. THE GRADIENT WAS 40 MMHG, AND THE VALVE AREA WAS 40 CM2. BASED ON THE MEDICAL RECORD REVIEW, THIS PATIENT WAS SEEN IN A FOLLOW UP FOR SEVERE AORTIC AND SEVERE MITRAL STENOSIS. THE PATIENT PRESENTED WITH WORSENING LEG WEAKNESS AND MOBILITY ISSUES AND HAD BEEN RECENTLY HOSPITALIZED FOR HEART FAILURE AND COPD. THE PATIENT ALSO REPORTED STILL HAVING SYMPTOMS RELATED TO THE MITRAL VALVE, DESPITE THE INTERVENTIONS. THE RECORD INDICATED THAT THE PATIENT WAS REPORTING SYMPTOMS CONSISTENT WITH AORTIC STENOSIS. AN ASSESSMENT DETERMINED THE PATIENT WOULD BE A REASONABLE CANDIDATE FOR A TAVR; HOWEVER, IT WAS NOTED THAT THE CURRENT MITRAL VALVE FUNCTION IS SUBOPTIMAL, BUT FURTHER INTERVENTION IS LIMITED. ADDRESSING THE AORTIC VALVE MAY ALLOW FOR MEDICATION ADJUSTMENTS TO MANAGE MITRAL VALVE SYMPTOMS. AN ECHO

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24718101 ↗
• InjuryMar 30, 2026Calcified

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST. AS REPORTED, A PATIENT WITH A 26MM SAPIEN 3 ULTRA RESILIA VALVE, IMPLANTED IN THE AORTIC POSITION FOR APPROXIMATELY 1 YEAR AND 8 MONTHS, UNDERWENT AN EXPLANT PROCEDURE DUE TO ELEVATED GRADIENTS AND LEAFLET CALCIFICATION. THE PATIENT WAS A RENAL PATIENT. A MECHANICAL VALVE WAS IMPLANTED IN REPLACEMENT. THE PATIENT TOLERATED THE PROCEDURE WELL. PER THE MEDICAL RECORDS, THE PATIENT PRESENTED WITH HEART FAILURE AND AN EJECTION FRACTION OF 20-25% FOR EXPLANT AND SURGICAL AVR WITH A NON-EW VALVE. THE THV VALVE WAS EXCISED AND NO VISUAL OBSERVATIONS WERE MENTIONED IN THE OPERATIVE NOTE. PATHOLOGY WAS PROVIDED WHICH WAS BOTH THE BIOPROSTHETIC AND NATIVE LEAFLETS MIXED IN ONE FORMALIN CONTAINER. THE ASSESSMENT OF THE LEAFLETS WAS PANNUS/CALCIFICATION/NO INFLAMMATION OR ENDOCARDITIS. IT IS UNCLEAR WHICH LEAFLETS ARE WHICH (BIOPROSTHETIC VS. NATIVE) BASED UPON THE REPORT.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24714868 ↗
• InjuryMar 26, 2026Degraded; Perivalvular Leak

  IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT THIS 26MM SAPIEN 3 ULTRA RESILIA VALVE IMPLANTED IN THE AORTIC POSITION FOR 6 MONTHS WAS EXPLANTED DUE TO HYPOATTENUATED LEAFLET THICKENING AND PERIVALVULAR LEAK. UNDER GENERAL ANESTHESIA, THE PATIENT HAD A REDO STERNOTOMY, TOTAL ARCH DEBRANCHING, AORTIC VALVE REPLACEMENT, SAPIEN 3 REMOVAL, AND RING AND SUBAORTIC MEMBRANE REMOVAL. A SURGICAL VALVE WAS IMPLANTED IN REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 24706874 ↗
• DeathMar 26, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  AS REPORTED BY PATIENT SUPPORT THEY RECEIVED A CALL FROM A CARE ADVOCATE AND THE PATIENT HAD A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 26MM SAPIEN 3 ULTRA RESILIA VALVE. HOWEVER, DUE TO COMPLICATIONS WITH BLEEDING FROM THEIR FEMORAL ARTERY A STENT WAS REPORTEDLY PLACED TO STOP THE BLEEDING, BUT THE PATIENT WAS NOT RECOVERING WELL AND TWO DAYS LATER IT WAS DECIDED TO PLACE THE PATIENT ON HOSPICE. THE FOLLOWING DAY THEY WERE TRANSFERRED TO HOSPICE WHERE THAT EVENING THEY EXPIRED. MEDICAL RECORDS WERE RECEIVED AND REVIEWED; THE PATIENT HAD A HEMATOMA WITH COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWING HEMATOMA AND ACTIVE EXTRAVASATION. VASCULAR SURGERY CONSULTED AND TAKEN TO OR WHERE STENT PLACED TO RIGHT EXTERNAL ILIAC ARTERY. RECEIVED 3 UNITS PACKED RED BLOOD CELLS (PRBCS). RECEIVED IV FLUIDS AND ECHOCARDIOGRAM THAT REVEALED LEFT VENTRICULAR EJECTION FRACTION LESS THAN 15%. THE PATIENT WAS HYPOTENSIVE REQUIRING TRIPLE PRESSOR THERAPY AND HIGH-FLOW NASAL CANNULA. PALLIATIVE CARE WAS CONSULTED AND THE DECISION WAS MADE BY THE PATIENT AND THEIR FAMILY TO PURSUE MEDICAL ORDERS FOR LIFE-SUSTAINING TREATMENT (MOLST) B CODE STATUS WITH COMFORT MEASURES ONLY. ON DAY

  Patient problems: Heart Block; Hematoma; Perforation of Vessels

  MAUDE report 24706769 ↗
• InjuryMar 26, 2026Calcified; Insufficient Device Problem Information

  AS REPORTED BY IMPLANT PATIENT REGISTRY, A PATIENT UNDERWENT EXPLANT OF THEIR 26MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION APPROXIMATELY 1 YEAR AND 5 MONTHS POST TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE DEVICE WAS EXPLANTED FOR AN UNKNOWN REASON AND REPLACED WITH AN EDWARDS SURGICAL VALVE.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 24695598 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, DURING A TAVR PROCEDURE WITH A 26MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION, THE FIRST VALVE EMBOLIZED. DURING DEPLOYMENT, AT ABOUT 80% DEPLOYED, APPEARED TO HAVE A PVC AND VALVE EMBOLIZED. THE TEAM WAS UNABLE TO MOVE IT BACK DOWN INTO AN ANNULUS. MULTIPLE ATTEMPTS WERE MADE TO PULL INTO DESCENDING WITH NO SUCCESS. TEAM DECIDED TO IMPLANT A NEW VALVE AND THEN CONTINUE WITH THE EMBOLIZED VALVE. THE SECOND VALVE WAS DEPLOYED WITH NO COMPLICATIONS. AFTER ATTEMPTING TO PULL THE VALVE BACK, AS WELL AS ATTEMPTING TO EXPAND THE VALVE IN THE ASCENDING USING A 29MM DS, TEAM DECIDED THE MOST STABLE WAY OF FIXING THE SITUATION WAS TO OPEN THE PATIENT, AND REMOVE THE EMBOLIZED VALVE. THE PATIENT LEFT THE ROOM IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 24665728 ↗

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