SAPIEN 3 Ultra System 9750CM26Recalls & reported problems

Summary

The FDA's MAUDE database contains 531 adverse event reports that list this exact device (DI 00690103207835), received between Jan 28, 2021 and May 29, 2026 — classified as 26 deaths, 215 injuries, 290 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (305 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 531 reports, in the reporter's own words as published by the FDA.

• 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 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, 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

  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, 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 23, 2026Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A RIGHT-SIDE TRANSFEMORAL TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 26MM SAPIEN 3 ULTRA RESILIA (S3UR) VALVE IN THE NATIVE AORTIC POSITION, THERE WAS SOME DIFFICULTY ENCOUNTERED WHEN TRYING TO ADVANCE THE 26MM COMMANDER DELIVERY SYSTEM (DS) INTO THE 14FR ESHEATH+, AT WHICH POINT THE NOSECONE OF THE DS EXITED THROUGH THE SEAM OF THE ESHEATH+. IN RESPONSE, THE ESHEATH+ WAS BROUGHT TO A STRAIGHTER SEGMENT OF THE PATIENT'S ANATOMY AND THE DS WAS ROTATED WHILE ENTERING THE ESHEATH+, WHICH ALLOWED THE DS TO SUCCESSFULLY ADVANCE. AN ADDITIONAL 2ML WAS ADDED TO THE BALLOON OF THE DS PRIOR TO INFLATION. DURING VALVE DEPLOYMENT, THE BALLOON TO THE DS BURST DUE TO THE CALCIUM BURDEN. THE S3UR VALVE WAS SUCCESSFULLY IMPLANTED AND THE ACCESS SITE WAS CLOSED WITHOUT COMPLICATION. THE DS AND ESHEATH+ WERE REMOVED AS A SINGLE UNIT AND ARE NOT AVAILABLE FOR RETURN/EVALUATION. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967730 ↗
• MalfunctionApr 22, 2026Burst Container or Vessel

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE WITH A 26 MM SAPIEN 3 ULTRA RESILIA VALVE, A COMMANDER DELIVERY SYSTEM BALLOON RUPTURE OCCURRED DURING VALVE DEPLOYMENT. THE REPORTER NOTED THAT THE RUPTURE WAS IDENTIFIED DURING INFLATION, AND BLOOD WAS SEEN IN THE SYRINGE. THE DELIVERY SYSTEM WAS PULLED BACK INTO THE SHEATH, AND BOTH THE COMMANDER SYSTEM AND THE ESHEATH+ WERE REMOVED TOGETHER. A NEW 14 FR ESHEATH+ WAS INSERTED, AND THE IMPLANTED VALVE WAS POST-DILATED USING A 24 MM NON-EW BALLOON. THE REPORTER INDICATED THAT ANNULAR-TO-LVOT CALCIUM WAS THE PERCEIVED ROOT CAUSE OF THE BALLOON RUPTURE. NO INJURY OR ADDITIONAL COMPLICATIONS WERE REPORTED, AND THE PATIENT REMAINED IN STABLE CONDITION FOLLOWING THE PROCEDURE. THE DEVICE-RELATED IMAGERY WAS REVIEWED, AND THE FOLLOWING WAS OBSERVED: BALLOON BURST RADIALLY AT THE DISTAL BALLOON SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24960927 ↗
• DeathApr 17, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY EDWARDS IMPLANT PATIENT REGISTRY (IPR), APPROXIMATELY THREE (3) DAYS POST TRANSSEPTAL TRANSCATHETER MITRAL VALVE REPLACEMENT (TMVR) PROCEDURE WITH A 26 MM SAPIEN 3 ULTRA VALVE IN THE NATIVE MITRAL VALVE, THE PATIENT PASSED AWAY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE VALVE CLINIC COORDINATOR (VCC). IT WAS REPORTED THAT THE PRELIMINARY CAUSE OF DEATH WAS ACUTE MASSIVE PULMONARY EMBOLISM (PE). THE AUTOPSY PERMIT FORM STATED THAT THE PRINCIPAL DIAGNOSIS WAS ACUTE HYPOXIC RESPIRATORY FAILURE; NO AUTOPSY PERFORMED. THE PATIENT HAD PRESENTED WITH STROKE-LIKE SYMPTOMS (FACIAL DROOP, DYSARTHRIA, BILATERAL LEG WEAKNESS), HYPOXIA, AND HYPOTHERMIA. IT WAS SUSPECTED THAT THE PE PRECIPITATED ACUTE HIGH RIGHT-SIDE PRESSURES/RIGHT VENTRICLE (RV) STRAIN/SLIGHT HYPOXIA. THIS WAS BELIEVED TO HAVE LED TO INCREASED RIGHT TO LEFT SHUNT AND WORSENING HYPOXIA. THE DEGREE OF HYPOXIA WAS CONSIDERED DISPROPORTIONATE TO THE SIZE OF THE PE ALONE. IT WAS SUBSEQUENTLY SUSPECTED THAT THE HYPOXIA CAUSED THE LACTIC ACIDOSIS AND STROKE-LIKE SYMPTOMS. ON NEUROLOGIC EXAMINATION UPON ARRIVAL AND OFF SEDATION, THE PATIENT DEMONSTRATED NO COUGH NOR GAG, AND NO RESPONSE TO NOXIOUS STIMULI. PUPILS WER

  Patient problems: Cardiac Perforation

  MAUDE report 24915584 ↗
• MalfunctionApr 16, 2026Burst Container or Vessel

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24895214 ↗
• InjuryApr 16, 2026Burst Container or Vessel; Difficult to Remove

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) DURING A TRANSCAROTID TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 26MM SAPIEN 3 ULTRA RESILIA VALVE, THERE WAS +1CC ADDED TO THE ATRION, UPON INFLATION OF THE 26MM COMMANDER DELIVERY SYSTEM (DS) BALLOON, DURING VALVE DEPLOYMENT, THE BALLOON RUPTURED. THE DECISION WAS MADE TO BRING THE 14F ESHEATH+ AND DS OUT AS A UNIT, SO A SECOND SHEATH AND DS WERE PREPPED AND THE ATRION WAS FILLED WITH NOMINAL VOLUME. WHEN THE SHEATH WAS REMOVED IT WAS NOTICED THERE WAS DAMAGE OBSERVED AT THE DISTAL END OF THE SHEATH, THE DISTAL TIP WAS SPLIT. THE INITIAL SHEATH AND DS WERE REMOVED FROM THE PATIENT AND THE SECOND SHEATH AND WAS INSERTED FOLLOWED BY THE SECOND DS. THE VALVE WAS THEN POST DILATED. THE CAROTID ARTERY NEEDED SURGICAL REPAIR, WHICH WAS SUCCESSFULLY COMPLETED BY THE SURGEON. THE PERCEIVED ROOT CAUSE OF THE BALLOON RUPTURE WAS STJ CALCIUM. THE SECOND SHEATH AND DS WERE THEN REMOVED. THE VALVE WAS SUCCESSFULLY IMPLANTED, AND THE PATIENT IS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Vascular Problem

  MAUDE report 24894551 ↗
• MalfunctionApr 16, 2026Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 26MM SAPIEN 3 ULTRA VALVE DURING VALVE DEPLOYMENT THE BALLOON ON THE 26MM COMMANDER DELIVERY SYSTEM (DS) BURST AFTER BEING GIVEN FULL VOLUME AT THE END OF INFLATION. THE SYSTEM WAS REMOVED WITH NO DIFFICULTY. THE BALLOON WAS INVESTIGATED AND IT WAS FOUND TO BE BROKEN LONGITUDINAL AS DESIGNED WITH NO MISSING PIECES. THE PERCEIVED ROOT CAUSE WAS SINOTUBULAR JUNCTION CALCIUM. THERE WAS NO HARM TO THE PATIENT, AND THEY ARE IN STABLE CONDITION. THE VALVE WAS SUCCESSFULLY IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24894535 ↗
• InjuryApr 7, 2026Device Dislodged or Dislocated

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) DURING A TRANSEPTAL TRANSCATHETER MITRAL VALVE REPLACEMENT (TMVR) WITH A 26MM SAPIEN 3 ULTRA RESILIA VALVE IN MITRAL ANNULAR CALCIFICATION (MAC) CASE, THEY WERE UNABLE TO CROSS THE SEPTUM WITH THE 26MM COMMANDER DELIVERY SYSTEM (DS), SO THE DECISION WAS MADE TO REMOVE THE DS AND THE 14F ESHEATH+ FROM THE PATIENT. UPON REMOVAL, IT WAS NOTED THAT THE VALVE WAS NOT REMOVED WITH THE DS AND THE VALVE HAD BECOME DISLODGED. THE VALVE WAS STILL ON THE WIRE IN THE PATIENT'S RIGHT FEMORAL VEIN. THE DECISION WAS MADE TO PARTIALLY DEPLOY THE VALVE IN THE RIGHT FEMORAL VEIN. A NEW DS, SHEATH AND VALVE WERE THEN PREPPED. WHEN THE NEW SHEATH WAS INSERTED, THE VALVE THAT WAS DEPLOYED IN THE RIGHT FEMORAL VEIN WAS PUSHED INTO THE INFERIOR VENA CAVA (IVC). THE DECISION WAS THEN MADE TO USE A 20MM NON-EDWARDS BALLOON WAS USED TO INFLATE THE VALVE. WHEN THE NEW VALVE WAS DEPLOYED IN THE MITRAL POSITION, THE IVC WAS MEASURED. AFTER SUCCESSFUL DEPLOYMENT OF THE SECOND VALVE, UPON PULLING BACK THE DS, THE DS BALLOON WAS THEN USED TO FURTHER EXPAND THE VALVE THAT WAS IN THE IVC. THERE WAS NO INJURY, AND THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL. T

  Patient problems: Foreign Body In Patient

  MAUDE report 24811252 ↗
• MalfunctionApr 7, 2026Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 26MM SAPIEN 3 ULTRA VALVE DURING VALVE DEPLOYMENT THE BALLOON OF THE 26MM COMMANDER DELIVERY SYSTEM (DS) RUPTURED SPIRALLY. THERE WAS SOME DIFFICULTY PULLING BALLOON COMPLETELY BACK INTO THE SHEATH, HOWEVER THE PHYSICIAN WAS ABLE TO PULL THE DS AND 14F ESHEATH+ OUT TOGETHER. UPON REMOVAL THERE WERE NO MISSING PIECES TO THE BALLOON. THERE WAS SOME DAMAGE TO THE TIP OF THE SHEATH FROM PULLING THE BALLOON BACK INTO IT, AND THERE APPEARED TO BE NO PERIPHERAL VESSEL DAMAGE TO BE SEEN WITH ANGIOGRAPHY. THE PERCEIVED ROOT CAUSE OF THE BALLOON IS THERE IS SOME LVOT CALCIUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24811220 ↗
• MalfunctionApr 7, 2026Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE USING A 26 MM SAPIEN 3 ULTRA VALVE, THE 26 MM COMMANDER DELIVERY SYSTEM BALLOON RUPTURED DURING VALVE DEPLOYMENT ON LEFT VENTRICULAR OUTFLOW TRACT (LVOT) CALCIUM. BLOOD WAS OBSERVED IN THE SYRINGE. THE VALVE WAS APPROPRIATELY DEPLOYED BEFORE THE BALLOON RUPTURED. A POST-DILATION WAS PERFORMED USING A 26 MM NON-EDWARDS BALLOON TO ENSURE COMPLETE VALVE DEPLOYMENT. DURING THE ATTEMPT TO WITHDRAW THE DELIVERY SYSTEM THROUGH THE 14FR ESHEATH+, THE WINGED BALLOON BECAME STUCK IN THE SEALS OF THE ESHEATH+. THE DELIVERY SYSTEM AND ESHEATH+ WERE SUBSEQUENTLY REMOVED AS A UNIT. THERE WAS NO DAMAGE OBSERVED ON THE ESHEATH+. THE PATIENT TOLERATED THE PROCEDURE WELL, AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24809231 ↗
• MalfunctionApr 5, 2026Burst Container or Vessel

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), A PATIENT UNDERWENT A TRANSFEMORAL PULMONIC VALVE REPLACEMENT (TPVR) PROCEDURE WITH A 26MM SAPIEN 3 ULTRA RESILIA VALVE INSIDE A PRE-EXISTING NON-EDWARDS TRANSCATHETER HEART VALVE IN THE PULMONIC POSITION. DURING THE PROCEDURE, THE BALLOON RUPTURED AT NOMINAL +1CC. THE PATIENT PREVIOUSLY HAD THREE CP-COVERED STENTS WITH NON-EDWARDS VALVE. DURING THIS PROCEDURE, TWO NON-EDWARDS TBE DEVICES WERE ALSO PLACED ALONG WITH THE SAPIEN VALVE. AS PER FOLLOW-UP WITH THE FCS, THE VALVE WAS ABLE TO BE FULLY DEPLOYED IN THE INTENDED LOCATION. NO INSTRUMENTS WERE USED TO REMOVE THE BALLOON COVER. A PRE-IMPLANT BAV WAS PERFORMED USING A 26MM NON-EDWARDS BALLOON AT 9ATM, AND AN ADDITIONAL +1CC WAS ADDED AT DEPLOYMENT. NO LEAK WAS NOTED IN THE DELIVERY SYSTEM, THOUGH BLOOD WAS SEEN IN THE SYRINGE. THERE WERE NO DIFFICULTIES WITH VALVE ALIGNMENT, WHICH WAS PERFORMED OUTSIDE THE BODY IN A STRAIGHT SECTION, AND NO DIFFICULTY WITHDRAWING THE DELIVERY SYSTEM, WHICH WAS REMOVED USING A NON-EDWARDS SHEATH. NO PATIENT INJURY OR COMPLICATION OCCURRED. THE PERCEIVED ROOT CAUSE OF THE BALLOON BURST WAS UNKNOWN, THOUGH CALCIFIED ANATOMY WAS NOTED. THE DEVICE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24786952 ↗
• MalfunctionApr 3, 2026Inflation Problem

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT A PATIENT UNDERWENT A TRANSFEMORAL TAVR PROCEDURE WITH A 26MM SAPIEN 3 ULTRA RESILIA VALVE. AS REPORTED, THE INFLATION DEPLOYMENT WAS ASYMMETRICAL. THE TEAM BELIEVED THAT LVOT CALCIUM AND ANNULAR CALCIUM CONTRIBUTED BY CAUSING MORE PUSH FORCE ON INFLOW OF BALLOON. THE VALVE WAS ABLE TO BE FULLY DEPLOYED. THE APPROXIMATE INFLATION/DEFLATION TIME WAS UNKNOWN. NO FLUID LOSS WAS NOTICED. THE RATIO OF CONTRAST TO SALINE IN THE INFLATION MEDIUM WAS 15 ML OF CONTRAST (15:85). THE VALVE DEPLOYED IN THE INTENDED LOCATION. THERE WAS NO SLOW INFLATION/DEFLATION TIME OR ANY OTHER ABNORMALITIES NOTED DURING PREP. THERE WAS NO DAMAGE SEEN ON THE DEVICE BEFORE OR AFTER THE REMOVAL. THERE WAS NO WITHDRAWAL DIFFICULTIES WITH THE DELIVERY SYSTEM AND/OR SHEATH. THERE WAS NO PATIENT INJURY. THE PATIENT'S FINAL OUTCOME WAS NOTED AS DISCHARGED. THE PROVIDED IMAGERY WAS REVIEWED, AND THE FOLLOWING WAS OBSERVED: INFLATION OF BALLOON WAS CONSTRAINED AT THE DISTAL END, WITH DISTAL CONSTRAINT EVENTUALLY OVERCOME AND FULL INFLATION ACHIEVED VALVE APPEARED ADEQUATELY BETWEEN MARKERS PRIOR TO DEPLOYMENT. JUST PRIOR TO THE DISTAL CONSTRAINT OF T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781822 ↗
• MalfunctionMar 26, 2026Difficult or Delayed Positioning; Inflation Problem; Malposition of Device

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE BY TRANSFEMORAL APPROACH, THE 26MM COMMANDER DELIVERY SYSTEM, 26MM SAPIEN 3 ULTRA RESILIA VALVE, AND CRIMPER WERE ALL PREPPED PER IFU WITH NO ISSUES AND HANDED OFF TO THE HEART TEAM. THERE WAS NO RESISTANCE DURING DELIVERY SYSTEM INSERTION THROUGH THE SHEATH. THERE WAS SOME TORTUOSITY AND SLIGHT RESISTANCE DURING VALVE ALIGNMENT, BUT THIS WAS MILD. TORTUOSITY WAS NOTED IN THE ABDOMINAL AORTA, AND THE VALVE ALIGNMENT REQUIRED UNLOCK/LOCK TWICE TO REMOVE BUILT UP TENSION DURING FINE ADJUSTMENT. DEVICE WAS NOT TORQUED DURING THE PROCEDURE. AS THE VALVE/SYSTEM WAS ADVANCED, THERE WAS THE APPEARANCE OF THE VALVE FRAME OVER THE PUSHER, BUT IT CANNOT BE DETERMINED IF THIS WAS AN OPTICAL ILLUSION. THE VALVE FRAME WAS POSITIONED SLIGHTLY BACK ON THE DELIVERY SYSTEM BEFORE VALVE DEPLOYMENT. THE VALVE/SYSTEM WAS ADVANCED ACROSS THE NATIVE ANATOMY, PUSHER WAS PULLED BACK WITHOUT ISSUE, AND THE VALVE/SYSTEM WAS READY FOR DEPLOYMENT. DURING VALVE DEPLOYMENT, UNUSUAL DEPLOYMENT WAS NOTED WHERE THE LEFT VENTRICULAR OUTFLOW TRACT/DISTAL END OF BALLOON WAS NOT INFLATING AS EXPECTED. THE PROXIMAL/P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706736 ↗
• MalfunctionMar 26, 2026Burst Container or Vessel

  AS REPORTED BY OUR FIELD CLINICAL SPECIALIST (FCS) DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT WITH A 26 MM SAPIEN 3 ULTRA VALVE THE INITIAL CATHETER WAS NOT PASSING SMOOTHLY THROUGH THE FULLY EXPANDABLE PORTION OF THE FIRST 14FR ESHEATH+, SO IT WAS EXCHANGED FOR A NEW 14FR ESHEATH+. THEN AS THEY WENT TO DEPLOY THE VALVE THE BALLOON ON THE 26 MM COMMANDER DELIVERY SYSTEM (DS) RUPTURED LONGITUDINALLY AND THEY COULD NOT GET ALL 23CC INTO THE VALVE BEFORE THE RUPTURE. THE DS WAS REMOVED WITHOUT ISSUE, AND A NEW DS WAS PREPPED AND INFLATED IN THE DEPLOYED VALVE TO FULLY EXPAND IT TO NOMINAL VOLUME. THE PATIENT REMAINED IN STABLE CONDITION, AND THE VALVE WAS IMPLANTED SUCCESSFULLY. THE PERCEIVED ROOT CAUSE OF THE RESISTANCE WAS THAT IT WAS BELIEVED THE EXPANDABLE PORTION WAS AGAINST THE GREATER CURVATURE IN A BEND IN THE VESSEL. THE PERCEIVED ROOT CAUSE OF THE BALLON BURST IS ANNULAR/LVOT CALCIUM NODULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24705477 ↗
• MalfunctionMar 25, 2026Burst Container or Vessel

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), A PATIENT UNDERWENT A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 26MM SAPIEN 3 ULTRA RESILIA VALVE IN AORTIC POSITION. DURING THE PROCEDURE, THE BALLOON RUPTURED AT THE VERY END OF VALVE DEPLOYMENT. THE DELIVERY SYSTEM WAS ABLE TO BE EXTRACTED FROM THE SHEATH WITHOUT ISSUE. PATIENT REMAINED STABLE WITHOUT PARAVALVULAR LEAK OR ELEVATED GRADIENT, AND NO POST-DILITATION NEEDED. THERE WERE NO OTHER COMPLICATIONS. AS PER FOLLOW-UP WITH THE FCS, THE VALVE WAS ABLE TO BE FULLY DEPLOYED IN THE INTENDED POSITION. NO INSTRUMENTS WERE USED TO REMOVE THE BALLOON COVER, AS IT REMAINED ATTACHED AND WAS SAFELY REMOVED FROM THE PATIENT THROUGH THE SHEATH. A BAV WAS NOT PERFORMED PRIOR TO IMPLANT. AN ADDITIONAL 2 CC OF VOLUME WAS ADDED TO THE BALLOON BEFORE INFLATION. NO LEAK WAS OBSERVED IN THE DELIVERY SYSTEM, BUT BLOOD WAS SEEN IN THE SYRINGE. THERE WERE NO DIFFICULTIES WITH VALVE ALIGNMENT, WHICH WAS PERFORMED IN A STRAIGHT SECTION, AND NO DAMAGE WAS NOTED TO ANY OTHER EDWARDS DEVICES. THE EVENT DID NOT RESULT IN ANY PATIENT INJURY OR COMPLICATION. THE PERCEIVED ROOT CAUSE OF THE BALLOON BURST WAS UNKNOWN; ALTHOU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689639 ↗
• MalfunctionMar 20, 2026Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, DURING A TRANSFEMORAL TAVR PROCEDURE WITH A 26 MM COMMANDER DELIVERY SYSTEM (DS), THE BALLOON RUPTURED BEFORE THE 26 MM SAPIEN 3 ULTRA RESILIA (S3UR) VALVE WAS 100% EXPANDED. THE DS WAS REMOVED, AND A NEW DS WAS OPENED AND PREPPED WITH +2 CC OF EXTRA CONTRAST. POST-DILATATION OF THE S3UR WAS SUCCESSFUL. THE PHYSICIAN TEAM BELIEVED THE BALLOON RUPTURED DUE TO LEAFLET CALCIUM. THE PATIENT LEFT THE ROOM IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650624 ↗
• MalfunctionMar 19, 2026Inflation Problem

  DURING A TRANSFEMORAL, LEFT-ACCESS TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE, THE 26MM SAPIEN 3 ULTRA RESILIA VALVE WAS NOT BETWEEN THE DELIVERY SYSTEM ALIGNMENT MARKERS WHEN DEPLOYED. DIFFICULTY WAS ENCOUNTERED DURING FINE ADJUSTMENT VALVE ALIGNMENT ON THE COMMANDER DELIVERY SYSTEM. ACCORDING TO THE REPORTER, THE FLEX WHEEL REACHED ITS MAXIMUM ADJUSTMENT RANGE AND WAS SUBSEQUENTLY RESET; HOWEVER, ADDITIONAL FLEX WHEEL ROTATION ONLY INCREASED TENSION AND DID NOT MOVE THE BALLOON TO ACHIEVE FURTHER ALIGNMENT. THE VALVE FRAME DID NOT REACH THE DISTAL BALLOON MARKER DURING INITIAL OR SECONDARY ATTEMPT AT ALIGNMENT. MISALIGNMENT WAS THE LENGTH OF THE DISTAL MARKER (APPROXIMATELY 1MM). DESPITE THE ALIGNMENT DIFFICULTY, THE VALVE WAS DEPLOYED USING THE VALVE FRAME LENGTH AND RADIOLUCENT LINE AS REFERENCE INSTEAD OF USING THE MIDDLE BALLOON MARKER. THE VALVE WAS ULTIMATELY DEPLOYED IN THE INTENDED LOCATION WITHOUT COMPLICATIONS. NO ISSUES WERE NOTED DURING DEPLOYMENT, AND THE PATIENT REMAINED IN STABLE CONDITION AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24644822 ↗

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