COMMANDER 9750CM29Recalls & reported problems

Summary

The FDA's MAUDE database contains 139 adverse event reports that list this exact device (DI 00690103217001), received between Feb 13, 2023 and Sep 18, 2026 — classified as 13 deaths, 54 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (62 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 139 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Device Dislodged or Dislocated

  As reported by Implant Patient Registry and the Field Clinical Specialist (FCS), during implant of a 29 mm Sapien 3 Ultra Resilia (S3UR) valve into a surgical valve in the mitral position, the Commander Delivery System was unable to advance past the patient's septum. Upon retrieving it a third time, the 29mm S3UR hit against the edge of the eSheath+ and the valve embolized. The 29mm S3UR was retrieved but the decision was made to switch to a 26mm S3UR with added volume in order to get past the septum. It did get past it with some difficulty, and the valve was implanted successfully. The patient was stable following the procedure. The perceived root cause of the crossing difficulty was anatomical challenges- thick septum and bad angles. No devices were damaged in the case.

  Patient problems: Foreign Body Embolism

  MAUDE report 50817853 ↗
• MalfunctionMay 28, 2026Burst Container or Vessel

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, DURING A RIGHT-SIDE TRANSFEMORAL ACCESS TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE WITH A 16FR ESHEATH+, COMMANDER DELIVERY SYSTEM, AND A 29MM SAPIEN 3 ULTRA RESILIA VALVE, THE COMMANDER BALLOON RUPTURED DURING INFLATION. THE REPORTER STATED THAT THE PATIENT HAD A CALCIFIED SINOTUBULAR JUNCTION (STJ). INFLATION OF THE COMMANDER BALLOON WAS DESCRIBED AS "SLOW AND DELIBERATE", AND NO ADDITIONAL VOLUME WAS ADDED TO THE BALLOON PRIOR TO INFLATION. WITH APPROXIMATELY 1 ML OF INFLATION VOLUME REMAINING, THE BALLOON RUPTURED. THE TEAM ATTEMPTED TO REMOVE THE DELIVERY SYSTEM FROM THE SHEATH, BUT WAS UNABLE TO DO SO, AS WITHDRAWAL DIFFICULTY OCCURRED WHEN REACHING THE DISTAL PORTION OF THE SHEATH IN THE AORTA. THE WAY THE BALLOON RUPTURED LEFT A LARGE AMOUNT OF MATERIAL TOWARDS THE NOSECONE. THIS RESULTED IN REMOVAL OF THE WIRE, SHEATH, AND BALLOON TOGETHER AS A SINGLE UNIT. A RADIAL TEAR TO THE DELIVERY SYSTEM BALLOON WAS NOTED. MODERATE PULSATILE BLOOD LOSS OCCURRED, AND PERCLOSE SUTURES WERE TIGHTENED. ADDITIONAL MANUAL PRESSURE WAS HELD FOR 15 MINUTES. AFTER THE PRESSURE HOLD, AN AORTOGRAM VERIFIED THAT FLOW BEYOND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25325753 ↗
• MalfunctionMay 22, 2026Fluid/Blood Leak; Difficult to Remove

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), A PATIENT UNDERWENT A TRANSSEPTAL TRANSCATHETER MITRAL VALVE REPLACEMENT (TMVR) PROCEDURE WITH A 29MM SAPIEN 3 ULTRA RESILIA VALVE INSIDE A PRE-EXISTING SURGICAL VALVE IN THE MITRAL POSITION. DURING THE PROCEDURE, THE IMPLANTING PHYSICIAN ENCOUNTERED DIFFICULTY ADVANCING THE VALVE ACROSS THE SURGICAL MITRAL VALVE. TO IMPROVE WIRE TRAJECTORY AND FACILITATE DEVICE TRACKING, THE TIP OF THE WIRE WAS SNARED FROM THE AORTA. THIS MANEUVER ALLOWED THE VALVE AND DELIVERY SYSTEM TO BE ADVANCED ACROSS THE SURGICAL VALVE. HOWEVER, ONCE POSITIONED, THE DELIVERY SYSTEM BALLOON FAILED TO INFLATE WHEN VALVE DEPLOYMENT WAS ATTEMPTED, AND BLOOD WAS OBSERVED ENTERING THE ATRION WHEN NEGATIVE PRESSURE WAS PULLED BACK. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE VALVE AND DELIVERY SYSTEM INTO THE 16FR ESHEATH, BUT THE VALVE WOULD NOT ENTER THE TIP OF THE SHEATH. AS A RESULT, THE PHYSICIAN OPTED TO CUT THE PROXIMAL END OF THE DELIVERY SYSTEM USING WIRE CUTTERS, AND THE 16FR ESHEATH WAS REMOVED OVER THE REMAINING PORTION OF THE FLEX CATHETER SHAFT. A 26FR NON-EDWARDS SHEATH WAS THEN INSERTED OVER THE FLEX CATHETER SHAFT AND ADVANCED INTO THE FEMORAL VEIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257700 ↗
• InjuryMay 20, 2026Difficult to Remove

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE USING A 29MM SAPIEN 3 ULTRA RESILIA VALVE, PRECLOSING THE ARTERY WAS CHALLENGING DUE TO THE PATIENT'S LARGE BODY HABITUS, AND INSERTION OF THE ESHEATH WAS DIFFICULT WHILE TUNNELING THROUGH A LONG, RESISTANT TISSUE TRACT AND INTO THE ARTERY. ONCE THE ESHEATH WAS FULLY INSERTED, THE TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE PROCEEDED AS PLANNED, AND A 29 MM SAPIEN 3 ULTRA RESILIA VALVE WAS SUCCESSFULLY DEPLOYED. INSERTION OF THE DELIVERY SYSTEM WAS MET WITH MODERATE RESISTANCE. UPON REMOVING THE DELIVERY SYSTEM, THERE WAS SIGNIFICANT RESISTANCE COMING BACK THROUGH THE ESHEATH. UNDER FLUOROSCOPY, IT APPEARED THAT THE RADIOPAQUE CUFF OF THE ESHEATH WAS NO LONGER AT THE DISTAL TIP OF THE ESHEATH, BUT RATHER MID SHEATH WITH THE DELIVERY SYSTEM. THE DECISION WAS MADE TO REMOVE THE DELIVERY SYSTEM AND ESHEATH TOGETHER. A 20MM DRYSEAL WAS THEN INTRODUCED AT THE SITE AND THE VASCULAR SURGERY TEAM WAS CALLED. UPON REMOVAL OF THE ESHEATH AND DELIVERY SYSTEM, IT WAS IDENTIFIED THAT THE INNER LINING OF THE ESHEATH SEPARATED FROM THE OUTER LINING AND BUCKLED ON ITSELF. VASCULA

  Patient problems: Unspecified Vascular Problem

  MAUDE report 25234627 ↗
• MalfunctionApr 28, 2026Burst Container or Vessel

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), IT WAS A CASE OF A 29 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH. DURING VALVE DEPLOYMENT THE COMMANDER BALLOON RUPTURED TOWARDS THE END OF THE INFLATION. VALVE WAS STABLE, RUPTURED BALLOON WAS REMOVED SAFELY AND VALVE WAS POST DILATED WITH A 28MM NON-EW BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25019047 ↗
• MalfunctionApr 23, 2026Burst Container or Vessel

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT DURING VALVE DEPLOYMENT AT THE END OF INFLATION, THE BALLOON OF THE COMMANDER DELIVERY SYSTEM RUPTURED. THE 29MM SAPIEN 3 ULTRA RESLIA VALVE WAS ABLE TO BE FULLY DEPLOYED AND WAS SUCCESSFULLY IMPLANTED. 2CC OF EXTRA VOLUME WAS ADDED TO THE BALLOON PRIOR TO THE INFLATION. THERE WAS NO DIFFICULTY WITHDRAWING THE DELIVERY SYSTEM. THE PATIENT WAS NOTED TO HAVE DONE WELL. OTHER THAN LEAFLET CALCIUM, THE PERCEIVED ROOT CAUSE WAS UNKNOWN. THERE WERE NO MISSING PIECES FROM WHAT THE TEAM COULD ALL SEE. PER EVALUATION OF THE PROVIDED IMAGES, THE FOLLOWING WAS OBSERVED: LONGITUDINAL AND RADIAL BALLOON BURSTS OF THE BALLOON WERE OBSERVED. NO MISSING BALLOON PIECES WERE OBSERVED. CALCIFICATION WAS PRESENT AT THE LANDING ZONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24973058 ↗
• MalfunctionApr 22, 2026Burst Container or Vessel

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, DURING DEPLOYMENT OF A 29MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION, THE COMMANDER DELIVERY SYSTEM BALLOON BURST. HOWEVER, THE VALVE APPEARED FULLY DEPLOYED. A NEW COMMANDER DELIVERY SYSTEM WAS PREPARED TO POST DILATE THE VALVE. HOWEVER, THE SECOND COMMANDER DELIVERY SYSTEM BALLOON ALSO RUPTURED. TTE SHOWED NO PARAVALVULAR LEAK AND A WELL-DEPLOYED VALVE WITH A MEAN GRADIENT OF 3MMHG. THERE WAS NO PATIENT INJURY. THE PATIENT WAS STABLE AND DISCHARGED. PER THE REPORTER, THE PERCEIVED ROOT CAUSE OF THE BALLOON BURSTS IS UNKNOWN BUT POSSIBLY COULD HAVE BEEN DUE TO CALCIUM IN THE LEFT VENTRICULAR OUTFLOW TRACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24961335 ↗
• MalfunctionApr 17, 2026Inflation Problem

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, A 29MM COMMANDER DELIVERY SYSTEM WAS USED TO DEPLOY A 29MM SAPIEN 3 ULTRA RESILIA VALVE IN THE NATIVE AORTIC ANNULUS. IT WAS NOTED THAT THE DELIVERY SYSTEM HAD BEEN TORQUED DURING THE PROCEDURE DUE TO A HORIZONTAL HEART AND A LEFT SUBCLAVIAN APPROACH. DURING VALVE DEPLOYMENT, THE DELIVERY SYSTEM BALLOON WOULD NOT COMPLETELY INFLATE. APPROXIMATE INFLATION TIME WAS 10 SECONDS, AND THE DEFLATION TIME WAS AN ADDITIONAL 10 SECONDS. ASYMMETRICAL INFLATION WAS NOT OBSERVED. THE VALVE WAS DEPLOYED IN THE INTENDED LOCATION BUT WAS LEFT UNDER EXPANDED. THERE WAS NO ISSUE WITHDRAWING THE DELIVERY SYSTEM THROUGH THE 16FR ESHEATH+. A SECOND DELIVERY SYSTEM WAS OPENED AND INSERTED THROUGH THE SAME ESHEATH+. THE SECOND DELIVERY SYSTEM WAS USED TO FULLY EXPAND THE VALVE, WHICH WAS COMPLETED WITHOUT INCIDENT. THERE WAS NO INJURY TO THE PATIENT, AND THE PATIENT WAS DISCHARGED. IT WAS NOTED THAT THE 16FR ESHEATH TIP WAS DAMAGED, WHICH WAS THOUGHT TO HAVE OCCURRED WHEN THE DELIVERY SYSTEM WAS TORQUED, AND WAS A RESULT OF DELIVERY SYSTEM MANIPULATION. THE PERCEIVED ROOT CAUSE OF THE DELIVERY SYSTEM'S INABILITY TO COMPLETELY INFLATE IS UN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24912953 ↗
• MalfunctionApr 14, 2026Deflation Problem

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), A PATIENT UNDERWENT A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 29MM SAPIEN 3 VALVE IN AORTIC POSITION. DURING THE PROCEDURE, THERE WAS DIFFICULTY DEFLATING THE BALLOON AFTER THE VALVE DEPLOYMENT. PER FOLLOW-UP WITH THE FCS, INFLATION TIME APPEARED NORMAL WITH APPROXIMATELY FIVE SECONDS OF FULL INFLATION DEPLOYMENT, WHILE DEFLATION TOOK ABOUT TWICE AS LONG AS USUAL. NEGATIVE PRESSURE WAS APPLIED MULTIPLE TIMES USING THE ATRION INFLATION DEVICE, AND THE BALLOON EVENTUALLY FULLY DEFLATED. THE VALVE WAS STILL ABLE TO BE FULLY DEPLOYED IN THE INTENDED LOCATION, AND NO ABNORMALITIES WERE NOTED DURING PREPARATION. THE DEVICE WAS NOT TORQUED, INFLATION WAS SYMMETRICAL, AND THERE WAS NO RESISTANCE DURING INSERTION THROUGH THE SHEATH. NO DAMAGE WAS OBSERVED ON THE DELIVERY SYSTEM OR SHEATH, AND NO FLUID LOSS OCCURRED. THE INFLATION MEDIUM CONSISTED OF 90% SALINE AND 10% CONTRAST. THERE WERE NO WITHDRAWAL DIFFICULTIES, AND THE ROOT CAUSE OF THE DEFLATION ISSUE WAS UNKNOWN. THE PATIENT EXPERIENCED NO INJURY AND REMAINED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877268 ↗
• MalfunctionApr 7, 2026Inflation Problem; Failure to Deflate

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) DURING A RIGHT SIDE TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 29MM SAPIEN 3 ULTRA RESILIA VALVE WHEN INFLATING THE BALLOON ON THE 29MM COMMANDER DELIVERY SYSTEM (DS) THE BALLOON WOULD NOT INFLATE COMPLETELY OR DEFLATE FULLY. THERE WAS ASYMMETRICAL INFLATION NOTED. THE DS WAS REMOVED AND A NEW DS WAS USED TO COMPLETE THE EXPANSION OF THE VALVE. UPON REMOVAL OF THE FIRST DS IT WAS NOTED THAT THE DS WAS KINKED UPON THE FLEX CATHETER. THE VALVE WAS SUCCESSFULLY IMPLANTED, AND THE PATIENT IS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24811210 ↗
• DeathApr 7, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE BY TRANSFEMORAL APPROACH, AFTER THE 29 MM SAPIEN 3 ULTRA RESILIA VALVE WAS DEPLOYED, THERE WAS A DROP IN THE ARTERIAL PRESSURE. ECHO SHOWED A MODERATE EFFUSION. A PERICARDIOCENTESIS WAS DONE AND THE SURGEON HAD TO OPEN THE CHEST TO REPAIR A LEFT VENTRICLE DISRUPTION, WHICH WAS THE LOCATION OF BLEEDING THAT LED TO THE EFFUSION. THE SURGEON STATED THAT THE ROOT CAUSE OF THE PERICARDIAL EFFUSION WAS DUE TO THE LUNDERQUIST WIRE. THIS WIRE WAS USED WITH THE COMMANDER SYSTEM FOR VALVE DEPLOYMENT. THERE WERE NO DEVICE DIFFICULTIES DURING THIS CASE. THE DELIVERY SYSTEM WAS SMOOTHLY ADVANCED ACROSS THE NATIVE VALVE. THE NOSE-CONE WAS NOT PUSHED, NEITHER WAS IT ADVANCED TOO FAR INTO THE APEX OF THE LV. AS REPORTED BY A CARE ADVOCATE TO EDWARDS PATIENT SUPPORT CENTER, "SOMETHING HAD GONE WRONG" DURING THE PROCEDURE, AND THE PATIENT'S VENTRICLE WAS "PUNCTURED". THE PATIENT WAS TRANSFERRED TO THE ICU BUT WAS NOT ABLE TO RECOVER OR "WAKE UP". IT WAS LATER FOUND THAT PATIENT ADDITIONALLY SUFFERED A STROKE, AND THE MEDICAL TEAM DECIDED THAT THERE WAS NOTHING FURTHER THEY COULD DO. ABOUT 5-6 DAYS

  Patient problems: Pericardial Effusion; Stroke/CVA

  MAUDE report 24809284 ↗
• DeathApr 1, 2026Difficult or Delayed Positioning

  AS REPORTED BY OUR FIELD CLINICAL SPECIALIST (FCS) DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) THE DEVICES WERE PREPPED PER THE INSTRUCTION FOR USE (IFU). THE VALVE WAS PROPERLY ALIGNED AND PUSHED TO AORTIC VALVE. IT APPEARED SOME RESISTANCE WAS MET WITH THE FIRST ATTEMPT AT CROSSING, A SECOND ATTEMPT AT CROSSING WAS MADE AND THE VALVE DOVE COMPLETELY ACROSS THE NATIVE VALVE. THE VALVE WAS PULLED BACK, PLACED IN PROPER POSITION AT BOTTOM CUSPS IN CO-PLANAR VIEW AND DEPLOYED IN 95/5 POSITION. THE PERCEIVED ROOT CAUSE OF THE DIFFICULTY CROSSING WAS CALCIFIED LEAFLETS. AN ECHO WAS PERFORMED SHOWING NO AORTIC INSUFFICIENCY (AI), PARAVALVULAR LEAK (PVL), OR EFFUSION. A ROOT SHOT WAS PERFORMED WITH LEFT AND RIGHT CORONARY ARTERY APPEARING TO FILL NORMALLY. THE PATIENT DEVELOPED ST WAVE CHANGED AND ECHO WAS AGAIN PERFORMED SHOWING A NEW PERICARDIAL EFFUSION. THE PATIENT BECAME UNSTABLE; THE CHEST WAS OPENED AND SUBSEQUENTLY WENT INTO CARDIAC ARREST AND WAS PRONOUNCED DEAD. THE GUIDEWIRE POSITION WAS MAINTAINED DURING CROSSING, THE VALVE LANDED IN THE INTENDED POSITION, THERE WERE NO DIFFICULTIES DURING VALVE ALIGNMENT, AND THE VALVE WAS BETWEEN MARKERS BEFORE VALVE

  Patient problems: Pericardial Effusion

  MAUDE report 24756846 ↗
• MalfunctionMar 25, 2026Inflation Problem

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE USING A 29 MM SAPIEN 3 ULTRA RESILIA VALVE, IT WAS NOTED THAT INFLATION OF THE 29 MM COMMANDER DELIVERY SYSTEM BALLOON REQUIRED AN EXTENDED PERIOD OF TIME, WHICH RESULTED IN A PROLONGED PACING RUN. THE INFLATION/DEFLATION TIME WAS MORE THAN 20 SECONDS. THE VALVE WAS ABLE TO BE FULLY DEPLOYED IN THE INTENDED LOCATION. THERE WAS NO SLOW INFLATION/DEFLATION TIME OR ANY OTHER ABNORMALITIES NOTED DURING DEVICE PREPARATION. THE DEVICE WAS NOT TORQUED DURING THE PROCEDURE. THERE WAS NO ASYMMETRICAL INFLATION NOTED. THERE WAS NO RESISTANCE ENCOUNTERED DURING ADVANCEMENT OF THE DELIVERY SYSTEM WITH VALVE THROUGH THE 16FR ESHEATH+. THERE WAS NO DAMAGE OBSERVED ON THE DELIVERY SYSTEM. THERE WAS ALSO NO DAMAGE OBSERVED ON THE ESHEATH+. NO FLUID LOSS WAS NOTICED. THERE WAS NO DIFFICULTY WITHDRAWING THE DELIVERY SYSTEM AND ESHEATH+. THE PATIENT WAS STABLE. THERE WAS NO PATIENT INJURY. IMAGERY WAS RECEIVED FOR EVALUATION. PER REVIEW OF THE PATIENT ANATOMY IMAGERY, THERE WAS SEVERE OVALITY OBSERVED IN THE ANNULUS AND LEFT VENTRICULAR OUTFLOW TRACT (LVOT). THE OVALITY RA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689939 ↗
• InjuryMar 16, 2026Burst Container or Vessel; Difficult to Remove

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), A PATIENT UNDERWENT A TRANSFEMORAL TAVR PROCEDURE WITH A 29MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION. DURING THE PROCEDURE, A BALLOON RUPTURE WAS NOTED DURING INFLATION OF THE BALLOON AT THE END OF VALVE DEPLOYMENT. BLOOD WAS SEEN IN THE SYRINGE, AND THE VALVE WAS SUCCESSFULLY DEPLOYED DESPITE THE RUPTURE. WITHDRAWAL OF THE DELIVERY SYSTEM WAS ATTEMPTED THROUGH THE ESHEATH BUT WAS UNSUCCESSFUL. ATTEMPTS INCLUDED RETRIEVAL FROM THE CONTRALATERAL SIDE WITH A SNARE; HOWEVER, BOTH APPROACHES FAILED. DIFFICULTY REMOVING THE SYSTEM WAS ENCOUNTERED WHEN THE RUPTURED BALLOON ENTERED THE DISTAL PORTION OF THE ESHEATH. DURING THESE ATTEMPTS, THE ESHEATH SEAM HAD SPLIT, PREVENTING REMOVAL OF THE DELIVERY SYSTEM THROUGH THE ARTERIOTOMY. A VASCULAR SURGEON WAS CALLED, AND A SURGICAL CUTDOWN WAS PERFORMED TO REMOVE THE DELIVERY SYSTEM AND REPAIR THE FEMORAL ARTERY. THERE WAS A TRANSVERSE TEAR IN THE BALLOON NOTED UPON REMOVAL. THE PATIENT REMAINED IN STABLE CONDITION FOLLOWING COMPLETION OF THE PROCEDURE AND VASCULAR REPAIR. NO INSTRUMENTS WERE USED TO REMOVE THE BALLOON COVER, AND NO BALLOON AORTIC VALVULOPLASTY WAS PERFORMED PRIOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605482 ↗
• MalfunctionMar 13, 2026Inflation Problem

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE USING A 29 MM SAPIEN 3 ULTRA RESILIA VALVE, THERE WAS SLIGHT DIFFICULTY ENCOUNTERED DURING THE FINE ADJUST PORTION OF VALVE ALIGNMENT. VALVE ALIGNMENT WAS ATTEMPTED IN A STRAIGHT SECTION OF THE ANATOMY. IT WAS ABLE TO BE RESOLVED BY UNLOCKING AND THEN RE-LOCKING. SUBSEQUENTLY, DURING VALVE DEPLOYMENT, THERE WAS NON-UNIFORM EXPANSION OF THE VALVE. IT WAS NOTED THAT WHILE DEPLOYING THE VALVE, THE DISTAL PORTION POINTING TOWARDS THE LEFT VENTRICLE (LV) OPENED SIGNIFICANTLY LATER THAN THE PROXIMAL PORTION OF THE VALVE DIRECTED TOWARDS THE AORTA. THE VALVE WAS REPORTED TO BE BETWEEN THE MARKERS BEFORE DEPLOYMENT. ULTIMATELY, THE VALVE DEPLOYED SATISFACTORY. POST-DEPLOYMENT ECHOCARDIOGRAPHY SHOWED THE VALVE WAS FULLY EXPANDED. THE PATIENT WAS TRANSFERRED FOR RECOVERY IN STABLE CONDITION. THERE WAS NO PATIENT INJURY. PER ADDITIONAL INFORMATION RECEIVED FROM THE FCS, THERE WAS NO DAMAGE OBSERVED ON THE DELIVERY SYSTEM AND NO DAMAGE OBSERVED ON THE ESHEATH+. THERE WAS NORMAL RESISTANCE DURING INSERTION OF THE DELIVERY SYSTEM WITH VALVE THROUGH THE SHEATH. THE INF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594769 ↗
• InjuryMar 13, 2026Difficult to Remove; Device Slipped; Device Dislodged or Dislocated; Material Integrity Problem; Material Split, Cut or Torn

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING IMPLANT OF A 29 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION, THERE WAS DIFFICULTY INTRODUCING THE COMMANDER DELIVERY SYSTEM INTO THE 16F ESHEATH+. IT WAS STUCK AT THE BLUE PORTION (SHEATH SHAFT/ FULLY EXPANDABLE) OF THE SHEATH. THE ESHEATH WAS INSERTED AND THE VESSEL WAS PRE-DILATED TO 18F. THE VALVE AND DELIVERY SYSTEM WERE ADVANCED IN NORMAL FASHION UNTIL SOME RESISTANCE WAS MET. BOTH THE IMPLANTING CARDIOLOGIST AND CARDIOTHORACIC SURGEON HAD DIFFICULTY PUSHING THE DEVICE AND FLURO SHOWED SOME BUCKLING ABOVE THE FEMORAL HEAD SO THE PUSH/PULL METHOD WAS UTILIZED AND THE VALVE WITH DELIVERY SYSTEM STARTED ADVANCING UNTIL IT MET MORE RESISTANCE IN THE EXTERNAL ILIAC. AT THAT POINT THEY COULD NOT ADVANCE THE SYSTEM ANYMORE AND THE DECISION WAS MADE TO TAKE EVERYTHING OUT AS A WHOLE AND START FRESH. THEY TRIED PULLING THE VALVE/DELIVERY INTO THE SHEATH MORE AND ENDED UP STRIPPING THE DELIVERY SYSTEM WITH THE PUSHER OFF OF THE VALVE TO WHERE THE VALVE WAS THEN ON THE BALLOON SHAFT. THE VALVE AND DELIVERY SYSTEM WAS STUCK IN THE ESHEATH+ WHICH WAS INSIDE OF THE EXTERNAL ILIAC. IT NEVER EXITED THE SHEATH. THE SYSTEM WA

  Patient problems: Insufficient Information

  MAUDE report 24589131 ↗
• MalfunctionMar 6, 2026Burst Container or Vessel; Fracture

  PER THE FIELD CLINICAL SPECIALIST, DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE UTILIZING A 29 MM SAPIEN 3 ULTRA RESILIA VALVE, AN ADDITIONAL 3 CC OF VOLUME WAS ADDED TO THE BALLOON PRIOR TO INFLATION. AT MAXIMUM INFLATION, THE BALLOON WAS OBSERVED TO RUPTURE, RESULTING IN BLOOD BEING DRAWN BACK INTO THE ATRIUM. CALCIFICATION WAS NOTED EXTENDING INTO THE MITRAL CURTAIN. CARE WAS EXERCISED DURING WITHDRAWAL OF THE DELIVERY SYSTEM AND BALLOON INTO THE SHEATH. INITIAL RESISTANCE WAS ENCOUNTERED, PROMPTING ADVANCEMENT OF THE SYSTEM INTO THE DESCENDING AORTA, ROTATION OF THE DELIVERY SYSTEM, AND A SUBSEQUENT ATTEMPT AT RE-SHEATHING. THE DELIVERY SYSTEM COULD NOT BE REMOVED FROM THE SHEATH; THEREFORE, BOTH THE SHEATH AND DELIVERY SYSTEM WERE REMOVED TOGETHER AS A SINGLE UNIT. UPON INSPECTION FOLLOWING REMOVAL, NO DAMAGE TO THE SHEATH WAS OBSERVED. IT WAS LATER REPORTED THAT THE PATIENT EXPIRED 24 HOURS AFTER VALVE IMPLANTATION. THE PHYSICIAN STATED THAT THE PATIENT EXPERIENCED CARDIAC ARREST IN THE HOSPITAL, WAS RETURNED TO THE CATHETERIZATION LABORATORY, AND WAS FOUND TO HAVE AN ANNULAR RUPTURE. THE PERCEIVED ROOT CAUSE WAS RUPTURE RELATED TO ANNULAR CALCIFICATION. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531215 ↗
• InjuryFeb 27, 2026Difficult to Remove; Device Dislodged or Dislocated

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING IMPLANT OF A 29 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE MITRAL POSITION VIA RIGHT TRANSFEMORAL VEIN WITHIN A NON-EW SURGICAL VALVE, A CLOT WAS OBSERVED AND TEAM DECIDED TO BAIL ON PROCEDURE, TREAT THE CLOT AND COME BACK FOR ANOTHER ATTEMPT. THERE WERE NO ISSUES ATTEMPTING TO REMOVE THE DELIVERY SYSTEM AND SHEATH OUT OF THE PATIENT, HOWEVER REMOVING THE 29MM S3UR POSED A DIFFERENT PROBLEM AND DAMAGE TO THE FEMORAL VEIN OCCURRED WHICH LED TO A SURGICAL REPAIR. AN END-TO-END PRIMARY SURGICAL CLOSURE WAS PERFORMED. THE PATIENT WAS STABLE AND WILL BE RE-EVALUATED AT A LATER DATE FOR THEIR TMVIV PROCEDURE. ADDITIONAL INFORMATION NOTED THAT "THE ISSUE IN THESE SITUATIONS IS THAT THE VALVE CANNOT BE RE-INTRODUCED INTO THE SHEATH. UPON REMOVING THE DELIVERY SYSTEM, THE VALVE HITS THE DISTAL END OF THE SHEATH AND SLIDES OFF THE DELIVERY SYSTEM. IT'S ESSENTIALLY FLOATING ON THE WIRE. WE WERE ABLE TO RETRACT IT TO THE ACCESS POINT NEAR THE GROIN. A HEMOSTAT WAS USED TO RETRIEVE THE VALVE. THAT'S WHEN THE INJURY TO THE VESSEL OCCURRED."

  Patient problems: Foreign Body Embolism; Unspecified Vascular Problem

  MAUDE report 24469485 ↗
• MalfunctionFeb 23, 2026Burst Container or Vessel

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), IT WAS AN OFF-LABEL CASE OF A 29 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE MITRAL POSITION VIA TRANSFEMORAL APPROACH WITH EXTRA 10 CC. DURING DEPLOYMENT, THE COMMANDER BALLOON RUPTURED. A SECOND COMMANDER SYSTEM WAS OPENED AND PREPARED AT THE PHYSICIAN'S REQUEST IN CASE POST-DILATION BECAME NECESSARY. THE VALVE REMAINED STABLE, AND THE PATIENT EXITED THE PROCEDURE ROOM IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24420339 ↗
• DeathFeb 18, 2026Inflation Problem

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) DURING A SUBCLAVIAN TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 29MM SAPIEN 3 ULTRA RESILIA VALVE, A LEFT AXILLARY CUTDOWN WAS PERFORMED AND A 16FR ESHEATH+ WAS ADVANCED, CALCIUM WAS NOTED ON CT (DIAMETER 11-12MM) AT LEFT AXILLARY OSTIUM, AND RESISTANCE WAS MET AS THE SHEATH WAS INTRODUCED. THE SHEATH WAS ABLE TO BE ADVANCED INTO THE ASCENDING AORTA. THE VALVE WAS INTRODUCED AND VALVE ALIGNMENT INITIATED. THE VALVE WAS NOT PERFECTLY CENTERED ON THE 29MM COMMANDER DELIVERY SYSTEM (DS) BALLOON, BUT THE SURGEON FELT TENSION WITHIN THE SYSTEM WAS EXCESSIVE AND WAS NOT COMFORTABLE ATTEMPTING FURTHER ALIGNMENT. THE BALLOON WAS PARTIALLY INFLATED WHEN THE VALVE WATERMELON SEEDED OFF THE DS BALLOON ONLY PARTIALLY DEPLOYED. THE DS BALLOON WAS ATTEMPTED TO BE PULLED INTO VALVE TO ATTEMPT TO FULLY OPEN THE VALVE. A SECOND VALVE AND DS WERE PREPPED. THE PATIENT ACUTELY DECOMPENSATED AND THE CODE RAN FOR 25 MINUTES. THE TIME OF DEATH WAS CALLED ON THE TABLE. TENSION WAS NOTED DURING GROSS AND FINE ADJUSTMENTS. VALVE ALIGNMENT WAS DONE IN THE ASCENDING AORTA. THE HEART WAS VERY HORIZONTAL AND ULTIMATELY, THE ANATOMY WAS NOT VERY STRAIGH

  Patient problems: Hemodynamic instability; Insufficient Information

  MAUDE report 24378604 ↗
• InjuryFeb 17, 2026Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, A BALLOON FAILURE OCCURRED DURING DEPLOYMENT OF A 29'MM TRANSCATHETER HEART VALVE. THE IMPLANT WAS PERFORMED IN THE NATIVE TRI-LEAFLET AORTIC POSITION VIA RIGHT TRANSFEMORAL ACCESS. PREPROCEDURAL IMAGING INDICATED AN 11.2% OVERSIZING RELATIVE TO THE INTENDED VALVE SIZE. PER THE IMPLANTING PHYSICIAN'S PREFERENCE, 2'CC OF ADDITIONAL VOLUME WAS ADDED TO THE DEPLOYMENT BALLOON. DURING VALVE DEPLOYMENT, THE VALVE WAS SUCCESSFULLY IMPLANTED AT +1'ML, AT WHICH POINT THE DELIVERY SYSTEM BALLOON RUPTURED, RESULTING IN CIRCUMFERENTIAL BALLOON TEARS. THE RUPTURE OCCURRED DURING INFLATION. BLOOD WAS OBSERVED IN THE SYRINGE. A ROOT ANGIOGRAM PERFORMED IMMEDIATELY AFTERWARD SHOWED A STABLE VALVE WITH NO PARAVALVULAR LEAK. FOLLOWING DEPLOYMENT, THE DELIVERY SYSTEM COULD NOT BE RETRACTED INTO THE 16'FR ESHEATH, RESULTING IN WITHDRAWAL DIFFICULTY. THE LEFT FEMORAL ACCESS SITE, INITIALLY A 7'FR SHEATH, WAS UPSIZED SEQUENTIALLY TO AN 18'FR DRYSEAL AND THEN TO A 24'FR DRYSEAL TO FACILITATE RETRIEVAL. A 10'18'MM ENSNARE INTRODUCED VIA A JR4 GUIDE CATHETER WAS USED TO CAPTURE THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24373429 ↗
• MalfunctionFeb 12, 2026Burst Container or Vessel

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), A PATIENT UNDERWENT A TRANSFEMORAL TAVR PROCEDURE WITH A 29MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION. DURING THE PROCEDURE, THE COMMANDER DELIVERY SYSTEM BALLOON RUPTURED WITH APPROXIMATELY 2CC OF INFLATION VOLUME REMAINING DURING THE VALVE DEPLOYMENT. BLOOD WAS NOTED IN THE SYRINGE. THE VALVE DID NOT FULLY DEPLOY DUE TO THE BALLOON BURST. NO LEAKAGE WAS OBSERVED ELSEWHERE IN THE SYSTEM, AND THERE WERE NO DIFFICULTIES WITH VALVE ALIGNMENT OR WITHDRAWING THE DELIVERY SYSTEM. IN RESPONSE TO THE BALLOON RUPTURE, THE TEAM PREPARED A NEW 29MM COMMANDER DELIVERY SYSTEM. THE REPLACEMENT SYSTEM WAS SUCCESSFULLY ADVANCED, AND THE VALVE WAS FULLY EXPANDED AND DEPLOYED IN APPROPRIATE POSITION. THE VALVE POST IMPLANT MEAN GRADIENT WAS 6MMHG. NO PRE-IMPLANT BAV WAS PERFORMED, AND NO EXTRA INFLATION VOLUME HAD BEEN ADDED PRIOR TO THE EVENT. NO DAMAGE TO OTHER EDWARDS DEVICES WAS OBSERVED. NO INJURY OR CLINICAL COMPLICATION OCCURRED, AND THE PATIENT REMAINED IN STABLE CONDITION FOLLOWING THE PROCEDURE. THE PERCEIVED ROOT CAUSE OF THE BALLOON BURST WAS ATTRIBUTED TO PATIENT ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328038 ↗
• InjuryFeb 12, 2026Difficult to Remove; Material Split, Cut or Torn

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A RIGHT TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 29MM SAPIEN 3 ULTRA RESILIA VALVE, THE 29MM COMMANDER DELIVERY SYSTEM (DS) WITH THE CRIMPED VALVE WAS ADVANCED THROUGH THE 16 ESHEATH+. FINAL ASSEMBLY OF THE VALVE WAS DONE IN THE DESCENDING AORTA. THE SYSTEM WAS MANIPULATED ACROSS THE ARCH WITH THE FLEXING MECHANISM. ONCE ACROSS THE AORTIC VALVE, THE PUSHER WAS RETRACTED BACK. AORTIC INJECTION WAS PERFORMED TO CONFIRM PROPER POSITIONING OF THE VALVE. WITH RAPID PACING, AORTOGRAPHY WAS PERFORMED TO ONCE AGAIN CONFIRM POSITIONING, AND THE BALLOON WAS SLOWLY INFLATED TO DEPLOY THE VALVE, PACEMAKER LOSS OF CAPTURE OCCURRED AND THE VALVE DISLODGED PROXIMALLY. THE DS WAS USED TO DRAG THE VALVE INTO THE ASCENDING AORTA. THE VALVE WAS POST DILATATED SUCCESSFULLY ANCHORING IT IN PLACE, BUT THE DS BALLOON RUPTURED. THE DS COULD NOT BE REMOVED FROM THE SHEATH INITIALLY DUE TO SOME WITHDRAWAL DIFFICULTY. THE DS WAS EVENTUALLY REMOVED BUT CAUSED A TEAR IN THE COMMON FEMORAL ARTERY. USING THE LEFT FEMORAL ACCESS, A RIM CATHETER WAS PLACED AND ACCESS OBTAINED INTO THE RIGHT COMMON ILIAC. A VERSA CORE WIRE WAS

  Patient problems: Insufficient Information; Perforation of Vessels

  MAUDE report 24324556 ↗
• InjuryFeb 6, 2026Burst Container or Vessel; Material Fragmentation; Difficult to Remove

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, COMMANDER DELIVERY BALLOON BURST, WITHDRAWAL DIFFICULTY, AND DEVICE COMPONENT SEPARATION RESULTING IN ADDITIONAL SURGERY OCCURRED. DURING THE DEPLOYMENT OF THE FIRST 29MM SAPIEN 3 ULTRA RESILIA IN THE AORTIC POSITION VIA RIGHT-TRANSFEMORAL APPROACH, THE 29MM COMMANDER DELIVERY SYSTEM BALLOON RUPTURED. PERCEIVED ROOT CAUSE OF THE BALLOON BURST WAS THE RAPHE FROM THE BICUSPID VALVE. THE VALVE LANDED 50/50 (AORTIC: VENTRICULAR) ON THE NON-CORONARY CUSP. THE IMPLANTER INTENDED TO IMPLANT THE DEVICE LOWER WITH THE ADDED VOLUME. PER REPORT, IT APPEARED AS THOUGH THE IMPLANTER WAS PUSHING IN ON THE DELIVERY SYSTEM DURING DEPLOYMENT. DURING WITHDRAWAL OF THE DELIVERY SYSTEM, THE DELIVERY SYSTEM BALLOON WOULD NOT COMPLETELY GO INTO THE 16FR ESHEATH+. THERE WAS NO RETAINED VOLUME IN THE BALLOON DURING WITHDRAWAL. THERE WAS COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM UPON RE-ENTRY INTO THE DISTAL END OF THE SHEATH, AND THE DELIVERY SYSTEM WAS COMPLETELY UNFLEXED. HOWEVER, THE DELIVERY SYSTEM BALLOON COULD ONLY BE WITHDRAWN ABOUT 3/4 OF THE WAY INTO THE SHEATH. THE SHEATH AND DELIVERY SYSTEM WERE PULLED BACK AND BECAME STUCK ON THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24282791 ↗
• InjuryFeb 4, 2026Difficult to Remove; Material Rupture

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, REGARDING IMPLANTATION OF A 29MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION. THE 29MM COMMANDER DELIVERY SYSTEM BALLOON RUPTURED DURING DEPLOYMENT. THERE WAS DIFFICULTY WITHDRAWING THE 29MM COMMANDER DELIVERY SYSTEM INTO THE 16F ESHEATH PLUS DUE TO THE CIRCUMFERENTIAL BALLOON RUPTURE. AN UP AND OVER SNARE WAS ATTEMPTED BUT IT WAS STILL NOT GOING INTO THE SHEATH. FINALLY, THE TEAM DECIDED TO SNARE THE DISTAL TIP AND GO UP AND OVER INTO A 22 FR SHEATH FROM THE LEFT SIDE. ONCE THE DISTAL TIP WAS PLACED INTO THE SHEATH ON THE LEFT SIDE, THE BACK OF THE BALLOON SYSTEM (ABOVE THE Y-CONNECTOR) WAS CUT. THE DELIVERY SYSTEM AND HALF OF THE BALLOON WAS REMOVED FROM THE RIGHT. REMOVED THE YELLOW TIP AND TOP OF THE BALLOON FROM THE LEFT SIDE. THEY DID NOTICE SOME LIMITED FLOW ON THE RIGHT SIDE AND HAD TO USE A DEVICE TO REMOVE SOME CLOTS FROM THE PATIENT. AFTER THIS PROCEDURE THE PATIENT HAD FLOW AND NO MAJOR ISSUES WERE NOTED. THE PATIENT LEFT THE PROCEDURE IN STABLE CONDITION.

  Patient problems: Insufficient Information

  MAUDE report 24262062 ↗

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 9600LDS23J 0
• 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