SAPIEN 3 Ultra System 9750CM20Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00690103207811), received between May 19, 2021 and Apr 17, 2026 — classified as 2 deaths, 14 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (29 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 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Burst Container or Vessel

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, A COMMANDER DELIVERY SYSTEM BALLOON BURST OCCURRED DURING IMPLANT OF A 20MM SAPIEN 3 ULTRA VALVE WITHIN A CONDUIT IN THE PULMONIC VALVE. AN 18MM NON-EW CONDUIT HAD MODERATE STENOSIS AND REGURGITATION. A 20M NON-EW BALLOON WAS USED TO ASSESS BASELINE WAIST. CONDUIT DILATION WAS PERFORMED WITH AN 18MM NON-EW DILATION CATHETER AND A 20MM DILATION CATHETER TO RBP AND CORONARY TESTING. A NON-EW STENT ON A 20MM BALLOON-IN-BALLOON WAS DEPLOYED AND POST DILATED WITH 20MM NON-EW DILATION CATHETER. THE STENT MEASURED 20MM. A 24FR NON-EW SHEATH WAS ADVANCED INTO THE MAIN PULMONARY ARTERY DISTAL TO THE STENT VIA THE RIGHT TRANSFEMORAL. A 20MM SAPIEN 3 ULTRA VALVE AND COMMANDER DELIVERY SYSTEM WITH +3CC ABOVE NOMINAL WERE PREPARED PER PHYSICIAN'S REQUEST. THE VALVE WAS ALIGNED ON THE DELIVERY SYSTEM UNDER FLUOROSCOPIC IMAGING BEFORE BEING INSERTED INTO THE PATIENT. DURING DEPLOYMENT OF THE VALVE, THE DELIVERY SYSTEM BALLOON RUPTURED AT THE LAST COUPLE ADDITIONAL CC OF INFLATION. THE DELIVERY SYSTEM BALLOON WAS RETRIEVED INTO THE SHEATH WITHOUT COMPLICATION. THE BALLOON APPEARED INTACT WITH A RADIAL BURST NOTED. POST ANGIOGRAPHY C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24913212 ↗
• MalfunctionApr 16, 2026Inflation Problem

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, A PATIENT WITH A 23MM SAPIEN 3 AORTIC VALVE IMPLANTED FOR 6 YEARS AND 4 MONTHS UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO STENOSIS AND REGURGITATION. DURING THE VALVE-IN-VALVE PROCEDURE, THERE WAS SOME RESISTANCE DURING DELIVERY SYSTEM INSERTION THROUGH THE SHEATH WHEN THEY GOT TO THE TIP OF THE SHEATH. THE CLEAR MOST DISTAL PART OF THE SHEATH TORE OFF MOST LIKELY DURING VALVE INSERTION. IT WAS NOTED WHEN THE VALVE WAS DEPLOYED. THE DISTAL TIP DID NOT DOG BONE LIKE USUAL BUT EVENTUALLY DID FULLY DEPLOY CORRECTLY AFTER THE BALLOON GOT ENOUGH PRESSURE. THERE WERE NO ACUTE NEGATIVE EFFECTS NOTED. THE SURGEON DECIDED NOT TO OPEN THE PATIENT TO LOOK FOR THE SEPARATED PIECE. THE SURGEON BELIEVES THE TIP IS STILL IN THE PATIENT. THE NEW VALVE LOOKED GOOD. THE ROOT CAUSE OF THE EVENT WAS THAT THE DISTAL TIP DID NOT OPEN WHEN THE VALVE WAS PASSED THROUGH THE TIP OF THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24901341 ↗
• MalfunctionMar 4, 2026Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 20MM SAPIEN 3 ULTRA RESILIA (S3UR) VALVE IN THE NATIVE AORTIC POSITION, THE BALLOON TO THE 20MM COMMANDER DELIVERY SYSTEM (DS) BURST DURING VALVE DEPLOYMENT, POSSIBLY DUE TO SINOTUBULAR JUNCTION CALCIUM. IT WAS NOTED THAT AN ADDITIONAL 2CC WAS ADDED TO THE BALLOON PRIOR TO INFLATION OF THE VALVE. AS THE VALVE WAS UNDER-EXPANDED, IT BEGAN TO MIGRATE TOWARDS THE LEFT VENTRICLE. THE DS WAS THEN WITHDRAWN FROM THE PATIENT THROUGH THE 14FR ESHEATH+ WHILE LEAVING THE ESHEATH+ IN PLACE. PER REPORT, THERE WAS NO SEPARATION OF THE BALLOON COMPONENTS. A SECOND 20MM S3UR VALVE WAS IMPLANTED, ELIMINATING ANY PARAVALVULAR LEAK, AND THERE WAS NO INJURY TO THE PATIENT. THE DS IS AVAILABLE FOR RETURN/EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506506 ↗
• MalfunctionFeb 20, 2026Burst Container or Vessel; Fluid/Blood Leak

  PER THE FIELD CLINICAL SPECIALIST, DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE USING A 20MM SAPIEN 3 ULTRA RESILIA VALVE, THE VALVE WAS APPROXIMATELY 80% DEPLOYED WHEN THE BALLOON RUPTURED. THE RUPTURE APPEARED TO ORIGINATE FROM A PINHOLE DEFECT LOCATED MID-BALLOON. THE TEAM PROCEEDED WITH A NON-EDWARDS BALLOON TO COMPLETE THE EXPANSION. THE PATIENT REMAINED STABLE AND LEFT THE CATHETERIZATION LAB IN GOOD CONDITION. THE CASE WAS NOTED TO HAVE SIGNIFICANT STJ CALCIUM. THE DEVICE WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24406294 ↗
• InjuryFeb 20, 2026Difficult to Remove

  AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, DURING A TAVR PROCEDURE WITH A 20MM COMMANDER DELIVERY SYSTEM, THE FINE ADJUSTMENT WAS ROLLED TOO FAR DURING VALVE ALIGNMENT. THE TEAM PULLED THE SYSTEM BACK INTO THE ESHEATH AND REMOVED THE ENTIRE SYSTEM AS ONE UNIT. A NEW ESHEATH WAS INSERTED, AND A NEW VALVE SYSTEM WAS PREPARED. THE REPLACEMENT VALVE WAS DEPLOYED, AND IMAGING SHOWED NO LEAK OR PARAVALVULAR LEAK. THE VALVE AND DELIVERY SYSTEM WERE THEN REMOVED. AFTER PULLING BACK THE SHEATH, AN INJECTION WAS PERFORMED, WHICH REVEALED A SPIRAL DISSECTION IN THE RIGHT FEMORAL ACCESS SITE FOLLOWED BY BALLOONING AND STENTING OF THE ARTERY. TWO VIABAHN STENTS WERE PLACED, AND A FINAL ANGIOGRAPHIC IMAGE SHOWED NO DISSECTION OR LEAK. THE PATIENT LEFT THE PROCEDURE ROOM IN STABLE CONDITION. THE PERCEIVED ROOT CAUSE FOR THE DISSECTION WAS DUE TO THE PROFILE OF THE VALVE AND BALLOON DURING REMOVAL OF THE 1ST SYSTEM. THERE WERE NO REPORTED WITHDRAWAL DIFFICULTIES WITH THE SYSTEM. A 2ND DELIVERY SYSTEM AND 20MM SAPIEN 3 ULTRA RESILIA VALVE WERE INSERTED, AND THE VALVE WAS SUCCESSFULLY IMPLANTED IN THE AORTIC POSITION. THE DEVICE WAS DISCARDED AT THE HOSPITAL.

  Patient problems: Vascular Dissection

  MAUDE report 24401526 ↗
• MalfunctionJan 5, 2026Inflation Problem

  DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE USING A 20 MM SAPIEN 3 ULTRA RESILIA VALVE, INITIAL VALVE ALIGNMENT WAS ACHIEVED BUT REQUIRED A RESET AND A SECOND ATTEMPT AFTER REACHING THE LIMIT OF FINE ADJUSTMENT. FOLLOWING SUCCESSFUL REALIGNMENT, THE DEVICE WAS ADVANCED ACROSS THE ARCH AND POSITIONED WITHIN THE ANNULUS. DURING DEPLOYMENT, THE BALLOON ON THE AORTIC SIDE INFLATED FIRST, WHILE INFLATION ON THE LEFT VENTRICULAR SIDE WAS MINIMAL. THE INTERVENTIONAL CARDIOLOGIST WAS INSTRUCTED TO ACCELERATE BALLOON INFLATION, RESULTING IN FULL VALVE EXPANSION AND SEATING AT 100/0. NO PARAVALVULAR LEAK WAS OBSERVED, AND THE BALLOON WAS REMOVED WITHOUT COMPLICATIONS. THE DEVICE WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23970106 ↗
• InjuryDec 8, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A RIGHT-SIDE TRANSFEMORAL TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 20MM SAPIEN 3 ULTRA RESILIA (S3UR) VALVE IN THE NATIVE AORTIC POSITION, THE OPERATING TEAM OVER-SHOT THE S3UR VALVE DURING VALVE ALIGNMENT. IT WAS NOTED THAT THE S3UR VALVE WAS ALMOST COMPLETELY OFF THE 20MM COMMANDER DELIVERY SYSTEM (DS). THE OPERATING TEAM DECIDED TO CROSS THE NATIVE VALVE IN AN ATTEMPT FOR THE S3UR VALVE TO SLIDE BACK ONTO THE BALLOON; HOWEVER, THIS RESULTED IN THE LOSS OF GUIDEWIRE ACCESS. IN RESPONSE, THE STIFF DEPLOYMENT WIRE WAS REMOVED, AND THIS CAUSED THE DS TO JUMP FORWARD, LEADING TO INJURY/PERICARDIAL EFFUSION. AFTER THE PATIENT WAS STABILIZED, THE FIRST SYSTEM WAS REMOVED AND A NEW SYSTEM WAS USED TO IMPLANT A 20MM S3UR VALVE. THE PATIENT WAS THEN TAKEN TO SURGERY TO LOCATE THE BLEED AND THE LV INJURY WAS SURGICALLY REPAIRED. PER REPORT, THE PATIENT HAS SINCE BEEN DISCHARGED HOME. ACCORDING TO THE REPORTING PHYSICIAN, HE DOES NOT BELIEVE THE LEFT VENTRICLE (LV) INJURY IS RELATED TO THE VALVE DEPLOYMENT OR POSITIONING, BUT RATHER, RELATED TO THE SAFARI GUIDEWIRE. IT WAS NOTED THAT THE PATIENT'S LV WAS FRIABL

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 23752690 ↗
• MalfunctionNov 18, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, A 20 MM SAPIEN 3 ULTRA RESILIA VALVE WAS IMPLANTED IN THE AORTIC POSITION. AT THE END OF BALLOON INFLATION, THE BALLOON RUPTURED. THE RUPTURE WAS ATTRIBUTED TO A SMALL AND HEAVILY CALCIFIED SINOTUBULAR JUNCTION (STJ), WHICH WAS KNOWN PRIOR TO THE PROCEDURE AND CONSIDERED A POTENTIAL RISK FACTOR. THE VALVE WAS SUCCESSFULLY DEPLOYED AND REACHED NOMINAL PRESSURE BEFORE THE BALLOON BURST. FOLLOWING THE RUPTURE, THE DELIVERY SYSTEM WAS ADVANCED TO THE DESCENDING AORTA AND MONITORED UNDER FLUOROSCOPY DURING REMOVAL FROM THE ESHEATH. THE TEAM CONFIRMED THAT ALL BALLOON MATERIAL REMAINED INTACT ON THE DELIVERY SYSTEM, AND NO FRAGMENTS WERE LEFT IN THE PATIENT. NO INSTRUMENTS WERE REQUIRED TO REMOVE THE BALLOON COVER. NO LEAKAGE WAS NOTED IN THE DELIVERY SYSTEM DURING THE PROCEDURE. BLOOD WAS OBSERVED IN THE INFLATION SYRINGE AFTER THE RUPTURE WHEN NEGATIVE PRESSURE WAS APPLIED. VALVE ALIGNMENT WAS PERFORMED IN A STRAIGHT SECTION WITHOUT DIFFICULTY, AND THERE WERE NO ISSUES WITHDRAWING THE DELIVERY SYSTEM. UPON INSPECTION, THE ONLY DAMAGE NOTED WAS A HORIZONTAL RUPTURE OF THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582752 ↗
• MalfunctionOct 30, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, A COMMANDER DELIVERY SYSTEM BALLOON BURST OCCURRED DURING DEPLOYMENT OF A 20MM SAPIEN 3 ULTRA RESILIA IN THE AORTIC PROCEDURE. ADDITIONAL VOLUME (+2CC) WAS ADDED TO THE DELIVERY SYSTEM PRIOR TO INFLATION. THE TEAM SUSPECTS THAT THE BALLOON SHOULDER CAME IN CONTACT WITH A PIECE OF CALCIFICATION ON THE SINOTUBULAR JUNCTION, CAUSING THE BALLOON TO BURST. THE VALVE WAS FULLY DEPLOYED, SO THE DELIVERY SYSTEM WAS WITHDRAWN SAFELY AND DISCARDED. THERE WAS NO INJURY TO THE PATIENT, AND THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425344 ↗
• MalfunctionSep 5, 2025Positioning Problem; Positioning Problem

  AS REPORTED BY A FIELD CLINICAL SPECIALIST DURING A VALVE-IN-VALVE PROCEDURE WITHIN A FAILED NON-EDWARDS VALVE WITH A 20MM SAPIEN 3 ULTRA RESILIA VALVE, A FLUSH OF ROTAGLIDE WAS USED TO FACILITATE THE PASSAGE OF THE VALVE THROUGH THE ESHEATH WITHIN PATIENT'S CALCIFIED FEMORAL ARTERY. WHEN ALIGNING VALVE, USER ERROR CONTRIBUTED TO THE BALLOON BEING PULLED TOO FAR INTO THE VALVE, SO THAT WHEN IT DEPLOYED THE TOP OF THE VALVE (OUTFLOW) WAS THE ONLY PART THAT EXPANDED BEFORE THE DELIVERY BALLOON WATERMELON-SEEDED AORTIC. THE TEAM WAS THEN ABLE TO RECROSS THE PARTIALLY-DEPLOYED VALVE AND EXPAND THE INFLOW, AND THEN INFLATE A THIRD TIME TO FULLY DEPLOY THE VALVE IN ENTIRETY WITHIN THE TRIFECTA. AT NO POINT DID AN EDWARDS PRODUCT CONTRIBUTE TO PATIENT INJURY, NOR WAS THERE ANY ALLEGATION OF MALFUNCTION OF ANY EDWARDS DEVICE. PATIENT TOLERATED PROCEDURE WELL, LEFT CATH LAB IN GOOD CONDITION. OPERATOR EDUCATION WAS GIVEN AFTER THE CASE WAS COMPLETE IN ORDER TO PREVENT REOCCURRENCE OF VALVE MISALIGNMENT IN FUTURE CASES. PER ADDITIONAL INFORMATION FROM THE FCS DIFFICULTY OCCURRED DURING FINE ADJUSTMENT. "WHEN I DEBRIEFED WITH THE PHYSICIAN, HE NOTED THAT HE WAS USED TO A CERTAIN LEVEL OF RESI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22979089 ↗
• InjuryAug 29, 2025Burst Container or Vessel; Difficult to Remove; Material Separation; Burst Container or Vessel; Difficult to Remove; Material Separation

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE (TAV) REPLACEMENT PROCEDURE WITH A 20MM SAPIEN 3 ULTRA RESILIA VALVE, THE BALLOON RUPTURED DURING DEPLOYMENT IN A TAV-IN-TAV PROCEDURE. REMOVAL OF THE DELIVERY SYSTEM WITHIN THE SHEATH CAUSED ACCORDION FOLDING OF THE DELIVERY BALLOON AT THE TIP OF THE SHEATH. THIS REMOVAL RESULTED IN A VASCULAR COMPLICATION REQUIRING SURGICAL INTERVENTION. THE PATIENT WAS ALIVE AT THE END OF THE TAVR PROCEDURE. PER PRE-DECONTAMINATION OBSERVATIONS, BALLOON MATERIAL WAS RETURNED SEPARATELY.

  Patient problems: Foreign Body In Patient; Hematoma; Insufficient Information; Vascular Dissection

  MAUDE report 22925660 ↗
• InjuryAug 27, 2025Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE BY TRANSFEMORAL APPROACH, DUE TO PATIENT ANATOMY, THE COMMANDER DELIVERY SYSTEM WOULD NOT PASS THE AORTIC BIFURCATION. THE DELIVERY SYSTEM WAS OUTSIDE OF THE SHEATH. THE TEAM DECIDED TO REMOVE THE SYSTEM. THE VALVE CAME OFF THE DELIVERY SYSTEM AND WAS IN THE LEFT ILIAC ARTERY. THE VALVE WAS INFLATED, AND A COVERED STENT WAS IMPLANTED ACROSS THE VALVE TO SECURE IT IN THE LEFT ILIAC ARTERY. THE PATIENT WAS DISCHARGED IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 22908892 ↗
• MalfunctionJul 28, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), DURING A TAVR PROCEDURE WITH A 20MM SAPIEN 3 ULTRA RESILIA VALVE, THE 20MM COMMANDER DELIVERY SYSTEM BALLOON BURST DURING VALVE DEPLOYMENT. THE VALVE WAS SUCCESSFULLY DEPLOYED. THE BALLOON WAS ABLE TO BE PULLED INTO SHEATH. THE SHEATH AND BALLOON WERE REMOVED AS A UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22639432 ↗
• InjuryJul 25, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, THE PATIENT WAS AN URGENT ADD ON TAVR IN SAVR CASE WITH A NON-EDWARDS VALVE IN THE AORTIC POSITION. PER THE CT MEASUREMENTS, THE PATIENT HAD MINIMAL VALVE TO CORONARY (VTC) DISTANCE AND VALVE TO AORTA (VTA) DISTANCE. THE PATIENT WAS NOT A SURGICAL CANDIDATE, SO THE TEAM DECIDED TO PERFORM A UNICORN PROCEDURE ON THE RIGHT CUSP AND SNORKEL STENT ON THE LEFT CORONARY ARTERY. THE TEAM WAS SUCCESSFULLY ABLE TO BURN THROUGH THE RIGHT CUSP BUT WHEN A 4MM PTA BALLOON WAS INSERTED TO DILATE THE CUSP OPENING, PATIENT DECOMPENSATED. A 20 MM S3UR VALVE WAS PREPPED PER IFU, AND TEAM ATTEMPTED TO DELIVER THE VALVE VIA UNICORN APPROACH BUT THEY WERE UNABLE TO ADVANCE THE VALVE THROUGH THE SURGICAL VALVE CUSP- AT THIS POINT IMPLANTER DECIDED TO DEPLOY THE VALVE. THE VALVE PARTIALLY CROSSED THE CUPS VIA UNICORN AND WOULD NOT FULLY PASS THROUGH AND AT THE POINT THEY DEPLOYED THE VALVE, AND IT LANDED HIGH INSIDE THE SURGICAL VALVE. THE CUSP PERF WAS THEN DILATED WITH A BIGGER BALLOON AND A NEW 20MM S3UR WAS THEN DEPLOYED AT THE INTENDED PLACEMENT INSIDE THE SAVR. PATIENT WAS UNSTABLE, CPR WAS BEING PERFORMED DURING THIS TIME. THE PATIENT WAS NEVER ABLE TO

  Patient problems: Insufficient Information

  MAUDE report 22613514 ↗
• MalfunctionJul 18, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, DURING A TRANSCATHETER TAVR PROCEDURE WITH A SAPIEN 3 ULTRA RESILIA VALVE, THE COMMANDER DELIVERY SYSTEM BALLOON BURST DURING THE DEPLOYMENT PHASE. THE RUPTURE WAS ATTRIBUTED TO HEAVY CALCIFICATION IN THE SINOTUBULAR JUNCTION (STJ). THIS RUPTURE LED TO ONLY PARTIAL DEPLOYMENT OF THE VALVE. THE VALVE WAS ABOUT 85% DEPLOYED. IMAGING REVEALED A PRESSURE DROP DURING INFLATION, AND BLOOD WAS OBSERVED IN THE SYRINGE. THE INFLATION/DEFLATION TIME WAS APPROXIMATELY 10 SECONDS. NO ASYMMETRICAL INFLATION WAS OBSERVED DURING THE PROCEDURE. DESPITE THE BALLOON RUPTURE, THE COMMANDER DELIVERY SYSTEM WAS REMOVED WITHOUT COMPLICATIONS. UPON REMOVAL OF THE DEVICES, THE BALLOON EXHIBITED A LONGITUDINAL TEAR, BUT THERE WAS NO DAMAGE TO OTHER COMPONENTS OF THE DELIVERY SYSTEM OR SHEATH, AND NO LEAKAGE WAS NOTED. A NEW COMMANDER DELIVERY SYSTEM WAS PREPARED AND THE VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE EVENT AND NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. THE ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE THE CALCIFICATION IN THE STJ.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22546780 ↗
• MalfunctionJun 13, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A RIGHT TRANSFEMORAL TAVR PROCEDURE WITH A 20M SAPIEN 3 ULTRA RESILIA VALVE, THE IN-SHEATH DILATOR WAS INSERTED ABOUT HALFWAY BEFORE STOPPING WITH A LOT OF RESISTANCE IN THE OPTIMA SHEATH. THE OPERATOR REQUESTED A STANDARD 14F ESHEATH+ TO BE OPENED. A NEW 20MM SAPIEN 3 ULTRA RESILIA VALVE WAS PREPPED AT +1CC. THE PUSH FORCE WAS VERY HIGH GOING THROUGH THE EXPANDABLE PART (BLUE PART) OF THE 14FR ESHEATH+, BUT EVENTUALLY ADVANCED SUCCESSFULLY. UPON DEPLOYMENT WHEN VALVE WAS APPROXIMATELY 95-100% DEPLOYED, THE BALLOON ON THE 20MM COMMANDER DELIVERY SYSTEM BURST. THE DELIVERY SYSTEM WAS SUCCESSFULLY RETRIEVED THROUGH ESHEATH+. A 20MM TRUE BALLOON WAS PREPPED AND USED TO POST DILATE THE VALVE TO ASSURE THE VALVE WAS FULLY EXPANDED. THERE WAS NO INJURY TO THE PATIENT WITH GOOD FINAL RESULTS. PER REPORT, THE MINIMUM VESSEL DIAMETER OF THE RIGHT COMMON FEMORAL WAS 5.8MM, AND THE RIGHT VESSEL WAS SUCCESSFULLY DILATED USING 16F DILATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22206821 ↗
• MalfunctionMay 9, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TAVR PROCEDURE WITH A 20MM SAPIEN 3 ULTRA RESILIA VALVE, THE 20MM COMMANDER DELIVERY SYSTEM BALLOON RUPTURED UPON DEPLOYMENT AT FULL INFLATION DUR TO CALCIUM IN THE SINOTUBULAR JUNCTION (FULL VOLUME OF 11CC'S DELIVERED). THE VALVE AND PATIENT REMAINED STABLE WHILE SECOND 20MM COMMANDER DELIVERY SYSTEM WAS PREPPED AND USED TO POST DILATE WITH +1CC ADDITIONAL VOLUME. THERE WAS NO INJURY TO THE PATIENT. PER REPORT, THERE WAS A LONGITUDINAL BALLOON RUPTURE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21998008 ↗
• MalfunctionMay 6, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE BY TRANSFEMORAL APPROACH, UPON DEPLOYMENT, THE COMMANDER DELIVERY SYSTEM BALLOON WAS OBSERVED TO BURST AT FULL INFLATION. THE TEAM WAS SATISFIED WITH FULL DEPLOYMENT OF THE VALVE. NO PARAVALVULAR LEAK WAS OBSERVED ON TRANSESOPHAGEAL ECHOCARDIOGRAM. THE BROKEN BALLOON WAS SUCCESSFULLY RETRIEVED THROUGH THE SHEATH AND THE PROCEDURE COMPLETED IN THE USUAL FASHION. THERE WAS NO ALLEGATION OF MALFUNCTION OR OBSERVED MISUSE OF ANY EDWARDS PRODUCT. CALCIFICATION AT THE SINOTUBULAR JUNCTION WAS ULTIMATELY CREDITED WITH BREAKING THE BALLOON. THE PATIENT TOLERATED THE PROCEDURE WELL AND LEFT THE OR IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21973299 ↗
• MalfunctionApr 28, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TAVR PROCEDURE WITH A 20MM SAPIEN 3 ULTRA VALVE, BALLOON OF THE 20MM COMMANDER DELIVERY SYSTEM RUPTURED NEAR THE END OF VALVE DEPLOYMENT. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21923180 ↗
• MalfunctionApr 23, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, A 20MM SAPIEN 3 ULTRA VALVE WAS IMPLANTED WITHIN AN EXISTING TRANSCATHETER HEART VALVE IN THE AORTIC POSITION BY TRANSFEMORAL APPROACH. COMMANDER DELIVERY SYSTEM BALLOON WAS PREPPED WITH 12ML VOLUME. DURING VALVE DEPLOYMENT, THE COMMANDER DELIVERY SYSTEM WAS ABOUT 80-90% INFLATED WHEN THE BALLOON BURST. THE DELIVERY SYSTEM WAS PULLED BACK INTO THE 14FR ESHEATH+ AND THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT AS A UNIT WITH THE DELIVERY SYSTEM BALLOON STILL OUTSIDE THE SHEATH. THE PERCEIVED ROOT CAUSE OF THE BALLOON BURST WAS THOUGHT TO BE EITHER INTERACTION WITH THE EXISTING VALVE FRAME OR CALCIFICATION ON THE LEAFLETS. A NEW 14FR ESHEATH+ WAS PLACED AND THE 20MM SAPIEN 3 ULTRA VALVE WAS POST DILATED USING A 20MM NON-EW BALLOON. THERE WAS NO LEAK AFTER POST DILATION. THE PATIENT WAS ALIVE AT THE END OF THE PROCEDURE. THERE WAS NO MAJOR VASCULAR COMPLICATION AND NO MAJOR BLEEDING. THE PATIENT WAS REPORTED TO BE DOING WELL THE DAY AFTER AND WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21893363 ↗
• MalfunctionMar 21, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TAVR PROCEDURE WITH A 20MM SAPIEN 3 ULTRA RESILIA VALVE, THE 20MM COMMANDER DELIVERY SYSTEM BALLOON RUPTURE DURING DEPLOYMENT. THE VALVE WAS FULLY DEPLOYED. ECHO REPORT SHOWED NO PARAVALVULAR LEAK. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665354 ↗
• DeathFeb 20, 2025Burst Container or Vessel; Material Fragmentation; Difficult to Remove; Burst Container or Vessel; Material Fragmentation; Difficult to Remove

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), DURING A TAVR PROCEDURE WITH A 20MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION, DURING INFLATION THE BALLOON RUPTURED ON CALCIUM IN THE STJ. THE DELIVERY SYSTEM WAS IMMEDIATELY ATTEMPTED TO BE REMOVED BUT BECAME STUCK PARTIALLY RETRIEVED INTO THE SHEATH. VASCULAR WAS CALLED; THEY WERE ABLE TO REMOVE THE SHEATH LEAVING THE DELIVERY SYSTEM BEHIND. WHEN ATTEMPTING TO REMOVE THE DELIVERY SYSTEM IT BECAME STUCK IN THE FEMORAL AND BROKE LEAVING BEHIND THE NOSECONE AND BALLOON. THE ARTERY WAS STABILIZED WITH MANUAL PRESSURE AND THE PATIENT REMAINED STABLE. THE PATIENT WAS INTUBATED AND THE ILLIAC WAS BALLOON OCCLUDED WHILE THEY DID A FEMORAL CUTDOWN TO REMOVE THE BROKEN END OF THE DELIVERY SYSTEM. THE BALLOON WAS REMOVED AND STENTS WERE PLACED IN THE FEMORAL ARTERY. THE VESSEL WAS SURGICALLY CLOSED. THE PATIENT REMAINED STABLE THROUGHOUT. UPON FOLLOW UP, THE FCS ADVISED THAT THE PATIENT WAS DISCHARGED HOME AFTER THE PROCEDURE. ON (B)(6) 2025 THEY WERE ADMITTED BACK TO THE HOSPITAL WITH ABDOMINAL PAIN. THEY WERE FOUND TO HAVE AN ISCHEMIC BOWEL. THE PATIENT EXPIRED ON (B)(6) 2025 FROM COMPLICATIONS FROM THEIR ISCHEMIC BOWEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21428605 ↗
• MalfunctionFeb 20, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, A PATIENT WITH A 23MM SAPIEN 3 AORTIC VALVE IMPLANTED FOR 5 YEARS AND 6 MONTHS UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO SIGNIFICANT CENTRAL AORTIC REGURGITATION RESULTING IN HEART FAILURE HOSPITALIZATION. THE PERCEIVED ROOT CAUSE OF THE REGURGITATION WAS LEAFLET ISSUES. A 20MM SAPIEN 3 ULTRA VALVE WAS IMPLANTED IN THE FAILED VALVE. UPON COMPLETION OF BALLOON EXPANSION/VALVE DEPLOYMENT THE COMMANDER DELIVERY SYSTEM BALLOON RUPTURED. AN EXTRA CC HAD BEEN ADDED TO THE BALLOON. THE TEAM DECIDED TO NOT POST-DILATE AS THEY FELT THEY HAD A GOOD RESULT DUE TO LOW GRADIENTS AND WHAT APPEARED TO BE FULL EXPANSION. THE BALLOON WAS SUCCESSFULLY REMOVED WITHOUT EVENT. THE PATIENT LEFT THE ROOM ALIVE AND WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21428096 ↗
• DeathFeb 12, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), THAT APPROXIMATELY 7 YEARS, 4 MONTHS AND 4 DAYS POST TAVR WITH A 23 MM SAPIEN 3 VALVE THE PATIENT DEVELOPED SEVERE STENOSIS. THE STENOSIS WAS TREATED WITH A VALVE IN VALVE USING A 20MM SAPIEN 3 ULTRA RESILIA VALVE. PER FOLLOW UP THE PATIENT UNDERWENT AN URGENT TAVR ON (B)(6) 2025, WHICH WAS COMPLICATED BY AN EXTENSIVE TYPE A DISSECTION. WHEN THE IMPLANTER WAS CROSSING THE EXISTING VALVE, WITH THE NEW VALVE, THE VALVE HAD SLIGHT TROUBLE CROSSING, GETTING HUNG UP ON THE PATIENTS EXISTING VALVE. THE ANGLE OF THE COMMANDER WIRE POSITION WAS CHANGED, AND THE VALVE SLID THROUGH. AFTER THE AORTOGRAM THERE WAS NO OBVIOUS DISSECTION. THEN THE PHYSICIAN ENGAGED THE RIGHT CORONARY. AT THE FINAL AORTOGRAM, A JET CONTRAST WAS NOTICED NEAR THE NON-SINUS. ON THE ECHO, THERE WAS NO PERICARDIAL EFFUSION, AND THE PATIENT'S BLOOD PRESSURE WAS STABLE. THE PATIENT WAS EXTUBATED AND SENT FOR A CT AFTER THE CASE. THE PATIENT DIED THAT EVENING. THE PROCEDURE WAS PLANNED FOR (B)(6) 2025, BUT THE PATIENT DEVELOPED NARROW COMPLEX VT IN THE 140'S ON (B)(6) 2025. TTE SHOWED THE AORTIC VALVE HAD TRACE REGURGITATION PRESENT, A PERCUTANEOUS STENTED BIO PROST

  Patient problems: Vascular Dissection

  MAUDE report 21367542 ↗
• MalfunctionNov 22, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, DURING A TAVR PROCEDURE WITH A 20MM SAPIEN 3 ULTRA RESILIA VALVE, THE 20MM COMMANDER DELIVERY SYSTEM BALLOON RUPTURED ON DEPLOYMENT. THE DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED FROM BODY WITH NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20761215 ↗

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