SAPIEN 3 Ultra SystemRecalls & reported problems across all models

We found 3 models of SAPIEN 3 Ultra System by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 876 adverse event reports in the FDA's MAUDE database, received between Jan 12, 2021 and Sep 2, 2026 — classified as 50 deaths, 312 injuries, 514 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (488 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 System problems

SAPIEN 3 Ultra System models

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

• SAPIEN 3 Ultra System 9750CM26

  Prosthesis, Mitral Valve, Percutaneously Delivered
  26 deaths531 reports
• SAPIEN 3 Ultra System 9750CM23

  Prosthesis, Mitral Valve, Percutaneously Delivered
  22 deaths290 reports
• SAPIEN 3 Ultra System 9750CM20

  Prosthesis, Mitral Valve, Percutaneously Delivered
  2 deaths55 reports

Recent SAPIEN 3 Ultra System adverse event reports

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

• MalfunctionSep 2, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50564735 ↗
• MalfunctionMay 29, 2026Inflation Problem

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 26 MM COMMANDER DELIVERY SYSTEM, THE BALLOON WAS OVER-ALIGNED WHILE POSITIONED IN THE DESCENDING AORTA. THE VALVE WAS NOT POSITIONED BETWEEN THE ALIGNMENT MARKERS. THIS WAS IDENTIFIED PRIOR TO DEPLOYMENT. AN ATTEMPT WAS MADE TO RETRACT THE VALVE INTO THE SHEATH TO REMOVE THE SYSTEM AS A SINGLE UNIT AND RESTART THE PROCEDURE; HOWEVER, THE VALVE COULD NOT BE RE-SHEATHED. THE PHYSICIAN WANTED TO PARTIALLY DEPLOY THE VALVE, COME DOWN ON THE BALLOON, GENTLY ADVANCE THE BALLOON AND THEN GO BACK UP ON THE BALLOON FOR FULL VALVE DEPLOYMENT. THE FIRST COMMANDER BALLOON INFLATION ONLY FLARED THE OUTFLOW PORTION OF THE VALVE. AT THAT TIME, THE VALVE WAS STABLE WITHIN THE ANNULUS, AND THE PATIENT REMAINED STABLE. THE PHYSICIAN WITHDREW THE DELIVERY SYSTEM FROM THE PATIENT AND ATTEMPTED TO USE A 24 MM NON-EDWARDS BALLOON FOR A SECOND INFLATION FOCUSING ON THE INFLOW SECTION OF THE VALVE. WHEN ATTEMPTING TO CROSS THROUGH THE VALVE, THE VALVE PUSHED THROUGH INTO THE LEFT VENTRICLE. THE PATIENT REMAINED STABLE AND WAS TAKEN TO THE OPERATING ROOM FOR RETRIEVAL OF THE TR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25336934 ↗
• InjuryMay 27, 2026Difficult to Remove

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 23 MM SAPIEN 3 ULTRA (S3U) VALVE, WIRE POSITION IN THE LEFT VENTRICLE (LV) WAS LOST WHILE THE DELIVERY SYSTEM WITH VALVE WAS CROSSING THE NATIVE AORTIC VALVE. THE LOSS OF WIRE POSITION WAS DUE TO THE WIRE BEING INADVERTENTLY PULLED OUT OF THE LV. THERE WAS NO PATIENT INJURY. THERE WAS DIFFICULTY WITHDRAWING THE DELIVERY SYSTEM WITH VALVE FROM THE PATIENT DUE TO SEVERE ILIAC DISEASE. VALVE ALIGNMENT WAS PERFORMED AND THE VALVE WAS SUBSEQUENTLY DEPLOYED IN THE DESCENDING AORTA. A SECOND 23 MM S3U VALVE WAS PREPPED AND DEPLOYED SUCCESSFULLY IN THE AORTIC VALVE. THERE WAS NO DAMAGE NOTED TO ANY EDWARDS DEVICES.

  Patient problems: Foreign Body In Patient

  MAUDE report 25311266 ↗
• InjuryMay 21, 2026Inflation Problem

  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 25249898 ↗
• MalfunctionMay 19, 2026Burst Container or Vessel; Material Separation

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 6 YEARS, 3 MONTHS, 1 DAY POST TRANSFEMORAL TAVR PROCEDURE WITH A 29MM SAPIEN 3 VALVE, THE VALVE PRESENTED STENOSIS. THE PATIENT UNDERWENT A SUCCESSFUL VALVE IN VALVE PROCEDURE WITH A 26MM SAPIEN 3 ULTRA RESILIA VALVE. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT PRESENTED SHORTNESS OF BREATH WITH A MEAN GRADIENT OF 56.5MMHG AND A PEAK GRADIENT OF 97.9MMHG. THE VALVE AREA/INDEX OF THE FAILED VALVE WAS 0.54 CM2. THE LEAFLETS WERE CALCIFIED WITH LIMITED MOBILITY. THE PATIENT WAS DISCHARGED HOME. DURING THE VALVE IN VALVE PROCEDURE, THE BALLOON ON THE 26MM COMMANDER DELIVERY SYSTEM BURST CIRCUMFERENTIALLY DURING VALVE DEPLOYMENT AT FULL INFLATION WITH +1CC. DURING WITHDRAWAL, THERE WERE DIFFICULTIES. HOWEVER, THE BALLOON WAS ABLE TO BE PULLED BACK INTO THE 14FR ESHEATH+ AND REMOVED. A NEW 14FR ESHEATH+ WAS INSERTED. THE PATIENT WAS STABLE AND THE ESHEATH+ WAS REMOVED WITH SUCCESSFUL GROIN CLOSURE. THE PATIENT WAS SENT TO RECOVERY. THERE WAS NO INJURY TO THE PATIENT. PER REPORT, BAV WAS PERFORMED PRE-IMPLANT. VALVE ALIGNMENT WAS PERFORMED IN A STRAIGHT SECTION. PER IMAGES RECEIVED, THE DISTAL TIP OF THE BALLOON WAS SE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216931 ↗
• InjuryMay 18, 2026Burst Container or Vessel; Difficult to Remove

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), A 26 MM EDWARDS TRANSCATHETER HEART VALVE SAPIEN 3 ULTRA RESILIA VALVE WAS IMPLANTED IN THE AORTIC POSITION. THE VALVE WAS REPORTED TO BE SUCCESSFULLY IMPLANTED, WITH NO CENTRAL LEAK OBSERVED, AND THE PATIENT WAS ALIVE AT THE END OF THE PROCEDURE. DURING THE PROCEDURE, A DEVICE-RELATED MALFUNCTION WAS ENCOUNTERED INVOLVING THE COMMANDER DELIVERY SYSTEM. DURING POST'DILATATION, THE BALLOON RUPTURED AT 6 ATMOSPHERES AND 24 CC, CONSISTENT WITH REPORTED CHARACTERISTICS OF BOTH A BALLOON BURST AND BALLOON TEAR (P1 AND P2). THERE WAS NO RETAINED VOLUME IN THE BALLOON. THE PHYSICIAN NOTED THE EVENT MAY HAVE BEEN POSSIBLY RELATED TO BULKY LEFT VENTRICULAR OUTFLOW TRACT (LVOT) CALCIUM. FOLLOWING THE RUPTURE, THERE WAS DIFFICULTY WITHDRAWING THE BALLOON INTO THE 14FR ESHEATH, DESPITE COAXIAL ALIGNMENT UPON RE'ENTRY, FULL UNFLEXING OF THE DELIVERY SYSTEM, AND THE FLEX TIP POSITIONED AT THE TRIPLE MARKER. DUE TO THE INABILITY TO WITHDRAW THE SYSTEM, THE PHYSICIAN ELECTED TO REMOVE THE DELIVERY SYSTEM AND ESHEATH TOGETHER AS A SINGLE UNIT, WHICH REQUIRED A SURGICAL CUTDOWN. DURING REMOVAL, RESISTANCE WAS ENCOUNTERED AT THE ARTERIOTOMY SITE, AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210439 ↗
• MalfunctionMay 13, 2026Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE, WHEN THE VALVE WAS FULLY DEPLOYED, THE 26MM COMMANDER DELIVERY SYSTEM BALLOON RUPTURED WHILE HOLDING THE BALLOON UP FOR 3-5 SECONDS AFTER DEPLOYMENT. THE COMMANDER WAS REMOVED FROM THE PATIENT WITHOUT ANY ISSUES. THERE WAS NO OTHER DAMAGE NOTED TO THE EDWARDS DEVICES. THERE WAS NO PATIENT INJURY. THE PERCEIVED ROOT CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25166776 ↗
• MalfunctionMay 8, 2026Crack

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE USING A 23MM SAPIEN 3 ULTRA RESILIA VALVE, THE SHEATH WAS INSERTED WITHOUT RESISTANCE AND THEN THE DELIVERY SYSTEM WAS INSERTED AND THE DELIVERY SYSTEM CATHETER CRACKED RELEASING FLUSH FROM THE CRACK. THE RESISTANCE WAS ATTRIBUTED TO ANGULATION OF THE SHEATH. IT WAS ADVISED BY THE FIELD CLINICAL SPECIALIST THAT THE SHEATH BE PULLED BACK SLIGHTLY TO REDUCE THE SEVERE ANGULATION CONTRIBUTING TO THE RESISTANCE. AFTER THE CRACK OF THE DS, IT WAS ADVISED BY THE REP TO REMOVE THE ENTIRE SYSTEM (SHEATH, DS, VALVE) AS ONE UNIT AS TO PREVENT STRIPPING OF THE VALVE. THE PHYSICIAN DECLINED TO EXCHANGE OR REMOVE THE SHEATH AT THAT TIME AND REQUESTED A NEW DELIVERY SYSTEM AND VALVE. A SECOND DELIVERY SYSTEM, PREPARED PER INSTRUCTIONS FOR USE WITH A NEW VALVE, WAS INSERTED INTO THE EXISTING ESHEATH, AT WHICH POINT RESISTANCE WAS AGAIN ENCOUNTERED. FLUOROSCOPIC IMAGING OF THE SHEATH DEMONSTRATED THAT TWO VALVES WERE VISIBLE WITHIN THE SHEATH. AT THAT POINT, THE SHEATH, DELIVERY SYSTEM, AND VALVES WERE REMOVED TOGETHER AS A SINGLE UNIT, AS INITIALLY RECOMMENDED. A NEW SHEATH WAS INTRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25128579 ↗
• MalfunctionMay 8, 2026Burst Container or Vessel

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, DURING A TAVR PROCEDURE WITH A 26MM SAPIEN 3 ULTRA RESILIA VALVE, THE 26MM COMMANDER DELIVERY SYSTEM BALLOON BURST. BALLOON RUPTURE WAS VISUALIZED ON FLUORO AND THERE WAS BLOOD IN THE ATRION WHEN IT WAS PULLED NEGATIVE. THE DELIVERY SYSTEM PULLED INTO SHEATH, BUT THERE WAS SOME RESISTANCE WHEN NOSE CONE WAS STILL 1-2CM OUTSIDE SHEATH. THEY WERE ABLE TO REMOVE THE SHEATH AND DELIVERY SYSTEM AS ONE UNIT. THE CASE WENT WELL, VALVE WAS DEPLOYED WITH GOOD RESULT, PATIENT LEFT ROOM IN STABLE CONDITION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25126114 ↗
• MalfunctionMay 6, 2026Material Rupture

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, REGARDING A 26 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION. THE 26 MM COMMANDER DELIVERY SYSTEM BALLOON RUPTURE OCCURRED DURING VALVE DEPLOYMENT. BALLOON WAS FULLY EXPANDED WITH +2 CC AND VALVED DEPLOYED SUCCESSFULLY. RETRIEVAL OF SYSTEM WITH NO DIFFICULTY, NO CONCERN FOR DEBRIS LEFT BEHIND. POTENTIAL ROOT CAUSE IS PATIENT ANNULAR CALCIUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25096415 ↗
• MalfunctionApr 29, 2026Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, DURING A TRANSFEMORAL TAVR PROCEDURE WITH A 23 MM COMMANDER DELIVERY SYSTEM, THE BALLOON RUPTURED DURING INFLATION. NO ADDITIONAL VOLUME WAS ADDED TO THE BALLOON PRIOR TO INFLATION. THE VALVE WAS SUCCESSFULLY DEPLOYED, AND NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED. AVAILABLE INFORMATION SUGGESTS THAT SINOTUBULAR JUNCTION CALCIUM MAY HAVE CONTRIBUTED TO THE BALLOON RUPTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035979 ↗
• MalfunctionApr 29, 2026Burst Container or Vessel

  IT WAS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), THAT DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 29MM SAPIEN 3 ULTRA RESILIA VALVE, THE BALLOON RUPTURED DURING VALVE DEPLOYMENT, AT FULL INFLATION WITH NOMINAL VOLUME DUE TO SHARP LEAFLET CALCIUM. POST DILATION WAS NOT REQUIRED, AND THE COMMANDER DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT ANY ISSUES AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035627 ↗
• MalfunctionApr 29, 2026Delivered as Unsterile Product

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), OUT OF BOX DURING PREPARATION OF DEVICES FOR IMPLANT OF A 23 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION, THE 23MM COMMANDER DELIVERY SYSTEM PACKAGING WAS TORN AND CONTAMINATED PRIOR TO OPENING THE PRODUCT ON THE BACK TABLE. THERE WAS NO PATIENT INVOLVEMENT. THE CONTAMINATED COMMANDER WAS REMOVED FROM THE ROOM AND DISCARDED AND A NEW 23MM COMMANDER DELIVERY SYSTEM WAS OPENED AND USED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034638 ↗
• MalfunctionApr 29, 2026Burst Container or Vessel; Difficult to Remove

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) THE 26MM COMMANDER DELIVERY SYSTEM (DS) BALLOON BURST AND PART OF THE BALLOON BECAME STUCK WITHIN THE DEPLOYED VALVE. THE FRAME OF THE INITIAL VALVE WAS DAMAGED DURING BALLOON REMOVAL. AFTER APPLYING SIGNIFICANT FORCE TO REMOVE THE DS, AS IT WAS GETTING CAUGHT ON THE INFLOW OF THE DEPLOYED VALVE, NON-CORONARY CUSP SIDE, THE INITIAL VALVE WAS PULLED OUT OF POSITION. UPON REVIEW, IT WAS DECIDED THAT THE VALVE SAT TOO HIGH TO SAFELY LEAVE AS IS, A VALVE IN VALVE WAS DONE USING ANOTHER 26MM SAPIEN 3 ULTRA RESILIA VALVE, AND THE SECOND VALVE WAS DEPLOYED IN THE 80/20 POSITION. THE PERCEIVED ROOT CAUSE OF THE EVENT WAS STJ CALCIFICATION. THE VALVE WAS SUCCESSFULLY DEPLOYED, THERE WAS NO PATIENT INJURY, AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034136 ↗
• MalfunctionApr 24, 2026Burst Container or Vessel

  IT WAS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), THAT DURING TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE, THE BALLOON ON THE 23 MM COMMANDER DELIVERY SYSTEM RUPTURED DURING VALVE DEPLOYMENT ON ANNULAR AND LEFT VENTRICULAR OUTFLOW TRACT CALCIUM. THE BALLOON RUPTURED AT FULL VOLUME. THE VALVE DEPLOYED SUCCESSFULLY AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24988579 ↗

Other Edwards Lifesciences LLC products

• Edwards SAPIEN 315 models · 6,905 reports · 1 recall
• 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
• FOGARTY32 models · 486 reports · 3 recalls
• EDWARDS COMMANDER DELIVERY SYSTEM4 models · 261 reports · 1 recall