SAPIEN 3 Ultra System 9750CM23Recalls & reported problems

Summary

The FDA's MAUDE database contains 290 adverse event reports that list this exact device (DI 00690103207828), received between Jan 12, 2021 and Sep 2, 2026 — classified as 22 deaths, 83 injuries, 185 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (154 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 290 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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, 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 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 ↗
• MalfunctionApr 10, 2026Burst Container or Vessel

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, DURING IMPLANT OF A 23MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION, THE COMMANDER DELIVERY SYSTEM BALLOON BURST AT INITIAL INFLATION AT NOMINAL VOLUME. THE DELIVERY SYSTEM WAS REMOVED SUCCESSFULLY AND THERE WAS NO INJURY TO THE PATIENT. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION BY THE PHYSICIAN. PER THE PHYSICIAN, THE PERCEIVED ROOT CAUSE OF THE BALLOON BURST WAS THE CALCIFIED SINOTUBULAR JUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839900 ↗
• DeathApr 8, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 23 MM SAPIEN 3 ULTRA VALVE, FOLLOWING SUCCESSFUL VALVE IMPLANTATION, AN EFFUSION WAS IDENTIFIED ON THE POST-DEPLOYMENT ECHOCARDIOGRAPHY, AND THE PATIENT'S BLOOD PRESSURE DROPPED. A PERICARDIAL DRAIN WAS PLACED, RESULTING IN IMPROVEMENT OF BLOOD PRESSURE; HOWEVER, BLEEDING PERSISTED. FURTHER EVALUATION DETERMINED A PERFORATION OF THE LEFT VENTRICLE (LV), WHICH WAS ATTRIBUTED TO THE GUIDEWIRE. THERE WERE NO REPORTED DIFFICULTIES TRACKING OR WITHDRAWING THE DELIVERY SYSTEM THROUGH THE PATIENT'S ANATOMY. THE PATIENT WAS CONVERTED TO OPEN CHEST SURGERY, AND THE LV WAS REPAIRED. THE PATIENT REMAINED STABLE THROUGHOUT THE LV REPAIR AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) IN STABLE CONDITION. THERE WAS NO ALLEGATION OF AN EDWARDS DEVICE DEFICIENCY. SUBSEQUENTLY, APPROXIMATELY TWO (2) MONTHS AND SIXTEEN (16) DAYS POST TAVR PROCEDURE, THE EDWARDS PATIENT SUPPORT CENTER (PSC) WAS NOTIFIED THAT THE PATIENT HAD PASSED AWAY "WHILE ATTEMPTING TO GET THE TAVR PROCEDURE". THE EXACT DATE AND CAUSE OF DEATH WERE NOT PROVIDED. NO ADDITIONAL INFORMATION W

  Patient problems: Cardiac Perforation

  MAUDE report 24818708 ↗
• MalfunctionApr 1, 2026Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE BY TRANSFEMORAL APPROACH, THE COMMANDER DELIVERY SYSTEM BALLOON RUPTURED DURING DEPLOYMENT ON SINOTUBULAR JUNCTION CALCIUM. THE 23MM SAPIEN 3 ULTRA VALVE WAS FULLY DEPLOYED WITH NO LEAK. THE BALLOON WAS REMOVED WITHOUT ISSUE. THE PATIENT WAS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757681 ↗
• MalfunctionMar 31, 2026Inflation Problem

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING IMPLANT OF A 23 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION VIA LEFT TRANSFEMORAL APPROACH, DURING INFLATION OF THE COMMANDER DELIVERY SYSTEM WHILE DEPLOYING THE VALVE, THERE WAS ASYMMETRICAL INFLATION AND DELAY OF INFLATION OCCURRED AT THE DISTAL PORTION OF THE BALLOON. THE VALVE WAS SUCCESSFULLY DEPLOYED WITH NO PATIENT INJURIES DUE TO THE INFLATION PROBLEMS. THE PATIENT WAS STABLE AND AWAITING VASCULAR REPAIR FOR A NON-EDWARDS CLOSURE DEVICE INJURY. PER IMAGING REVIEW, ESHEATH+ DISTAL TIP TEAR AND SYSTEM COMPONENTS SEPARATE WERE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746500 ↗
• MalfunctionMar 31, 2026Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) APPROXIMATELY 8 YEARS, 3 MONTHS AND 26 DAYS POST TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 26MM SAPIEN 3 VALVE THE VALVE FAILED DUE TO STENOSIS, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE GRADIENT WAS GREATER THAN 50MMHG AND THE VALVE AREA INDEX WAS 0.5. THERE WAS LEAFLET THICKENING. THE PATIENT HAD A VALVE IN VALVE USING A 23MM SAPIEN 3 ULTRA RESILIA VALVE. DURING VALVE DEPLOYMENT NEAR THE END OF INFLATION THE BALLOON OF THE 23MM COMMANDER DELIVERY SYSTEM (DS) RUPTURED. THERE WAS SOME RESISTANCE PULLING THE DS BACK INTO THE SHEATH. THE DS AND THE 14F ESHEATH+ WERE REMOVED WERE REMOVED AS ONE UNIT, THE SHEATH WAS BULGED AT THE DISTAL TIP WHERE THE BALLOON MATERIAL WAS PULLED BACK INSIDE OF IT, AND A NEW SHEATH WAS PUT IN SO THE VALVE COULD BE POST DILATED. A NEW SHEATH WAS INSERTED, AND THE VALVE WAS POST DILATED WITH A 22MM TRUE BALLOON. THE VALVE WAS SUCCESSFULLY PLACED, AND THE PATIENT IS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743350 ↗
• MalfunctionMar 31, 2026Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE DURING VALVE DEPLOYMENT THE BALLOON OF THE 23MM COMMANDER DELIVERY SYSTEM (DS) BURST. THE BALLON BURST AT THE VERY END OF INFLATION WHEN THE BALLOON WAS READY TO BE DEFLATED. THERE WAS 3CC EXTRA VOLUME ADDED TO THE BALLOON PRIOR TO INFLATION. THE VALVE WAS SUCCESSFULLY IMPLANTED, AND THE PATIENT IS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742907 ↗
• MalfunctionMar 24, 2026Burst Container or Vessel

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, DURING A TAVR PROCEDURE WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE, THE 23MM COMMANDER DELIVERY SYSTEM BALLOON BURST DURING THE END OF INFLATION. THE VALVE WAS ABLE TO BE SUCCESSFULLY DEPLOYED. THERE WERE NO INSTRUMENTS USED TO REMOVE THE BALLOON COVER, NO BAV AND NO EXTRA VOLUME ADDED TO THE BALLOON PRIOR TO INFLATION. THERE WAS BLOOD OBSERVED IN THE SYRINGE. VALVE ALIGNMENT WAS PERFORMED IN A STRAIGHT SECTION OF ANATOMY. THERE WERE NO WITHDRAWAL ISSUES. UPON REMOVAL IT WAS NOTED THE BALLOON WAS SPLIT IN THE PROXIMAL PORTION 1/3. THERE WAS NO PATIENT INJURY. THE PATIENT HAD SUPER HEAVY CALCIFICATION OF THE STJ, DISCUSSED PRIOR FOR RISK OF RUPTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678017 ↗
• MalfunctionMar 24, 2026Burst Container or Vessel

  PER THE FIELD CLINICAL SPECIALIST, DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE USING A 23MM SAPIEN 3 ULTRA RESILIA VALVE, DURING INFLATION THERE WAS TOO MUCH FORWARD PRESSURE ON COMMANDER SYSTEM AND ADVANCED THE VALVE VENTRICULAR RESULTING IN A FINAL POSITION OF 50/50. DUE TO THE SUBOPTIMAL POSITION OF THE FIRST VALVE, A SECOND VALVE WAS IMPLANTED SUCCESSFULLY, WHILE THE FIRST VALVE REMAINED IN SITU. DURING DEPLOYMENT OF THE SECOND VALVE, A BALLOON RUPTURE OF THE SECOND COMMANDER DELIVERY SYSTEM WAS OBSERVED AND POST DILATED WITH A 22MM TRUE BALLOON. DESPITE THIS ADDITIONAL EVENT, THE SECOND VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED IN STABLE CONDITION FOLLOWING THE PROCEDURE. THE POSSIBLE ROOT CAUSE OF THE BALLOON BURST, AS STATED BY THE FIELD CLINICAL SPECIALIST, WAS ATTRIBUTED TO THE FIRST SAPIEN VALVE BEING IMPLANTED AT 50/50. THE DEVICE WILL NOT BE RETURNED. THE INITIAL REPORTER DID NOT ALLEGE ANY DEVICE DEFICIENCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24676957 ↗
• MalfunctionMar 23, 2026Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WAS PERFORMED VIA THE RIGHT FEMORAL ACCESS TO IMPLANT A 23 MM SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE (THV) IN THE AORTIC POSITION. THE PATIENT IS A (B)(6) YEAR OLD FEMALE. DURING VALVE DEPLOYMENT, A BALLOON ISSUE OCCURRED ON THE DELIVERY SYSTEM. SPECIFICALLY, THE INFLATION BALLOON RUPTURED DURING INFLATION, RESULTING IN PARTIAL VALVE DEPLOYMENT (~95%). THE PROCEDURE TEAM NOTED BLOOD IN THE SYRINGE CONSISTENT WITH BALLOON RUPTURE. THERE WAS NO LEAKAGE OBSERVED FROM THE DELIVERY SYSTEM AND NO DIFFICULTY WITH VALVE ALIGNMENT (ALIGNMENT PERFORMED IN A STRAIGHT SECTION OF THE ANATOMY) OR WITH WITHDRAWAL OF THE DELIVERY SYSTEM. BALLOON SHAFT DAMAGE WAS REPORTED; NO ADDITIONAL DAMAGE TO OTHER EDWARDS COMPONENTS (E.G., FLEX SHAFT OR SHEATH) WAS NOTED. IN RESPONSE TO THE BALLOON RUPTURE AND PARTIAL DEPLOYMENT, THE DELIVERY SYSTEM WAS REMOVED, AND A 22 MM NON-EDWARDS BALLOON WAS ADVANCED AND INFLATED TO COMPLETE DEPLOYMENT OF THE THV. A PRE IMPLANT BAV WAS NOT PERFORMED, AND NO EXTRA VOLUME HAD BEEN ADDED TO THE EDWARDS DEPLOYMENT BALLOON PRIOR TO INFLATION. THE VALVE WAS SUCCESSFULLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670825 ↗
• MalfunctionMar 16, 2026Burst Container or Vessel

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), DURING A TAVR PROCEDURE WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION, A BALLOON RUPTURED DURING VALVE DEPLOYMENT, DURING THE LAST CC INFLATED IT WAS NOTED THAT THE BALLOON HAD RUPTURED. THE BALLOON/DELIVERY SYSTEM WAS REMOVED FULLY INTACT WITHOUT ISSUE. THE VALVE WAS ASSESSED WITH ECHO AND DETERMINED TO BE FULLY EXPANDED. NO PVL, ECHO GRADIENT 5MMHG, NO PATIENT INJURY. THERE WAS STJ CALCIUM NOTED PRE PROCEDURALLY AND BALLOON RUPTURE WAS A RISK THAT WAS DISCUSSED PRE PROCEDURE. UPON FOLLOW UP, THE FCS ADVISED THAT THE BALLOON ISSUE MOST CONSISTENT WITH THE EVENT WAS A BALLOON BURST, WITH NO PHOTOS AVAILABLE. NO INSTRUMENTS WERE USED TO REMOVE THE BALLOON COVER, NO EXTRA VOLUME WAS ADDED PRIOR TO INFLATION, AND NO DELIVERY SYSTEM LEAK WAS NOTED. BLOOD WAS OBSERVED IN THE SYRINGE, BUT THERE WERE NO DIFFICULTIES WITH VALVE ALIGNMENT, WHICH WAS PERFORMED IN A STRAIGHT SECTION. NO DAMAGE WAS SEEN ON ANY EDWARDS DEVICES. AFTER DEVICE REMOVAL, THE AREA OF LEAKAGE COULD BE IDENTIFIED. THE PATIENT WAS TRANSFERRED TO PACU IN STABLE CONDITION WITH NO COMPLICATIONS REPORTED. A 3MENSIO REPORT WAS ATTACHED FOR ASSESSMENT OF ANNU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24612160 ↗
• DeathMar 11, 2026Difficult or Delayed Positioning; Material Twisted/Bent; Positioning Problem; Physical Resistance/Sticking

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, REGARDING A 23MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION. THE FIRST 23MM COMMANDER DELIVERY SYSTEM HAD A LOT OF BUILT UP TENSION IN THE ARCH NEAR LEFT SUBCLAVIAN. THORACIC AORTA TORTUOSITY SYSTEM ADVANCED FLEX ADDED. THE 23MM SAPIEN 3 ULTRA VALVE CROSSED THE NATIVE VALVE BUT PUSHER WOULDNT PULL BACK AND A KINK WAS NOTED ON THE 23MM COMMANDER DELIVERY SYSTEM. THE ENTIRE SYSTEM WAS REMOVED. A SECOND 23MM SAPIEN 3 ULTRA VALVE, 23MM COMMANDER DELIVERY SYSTEM, AND 14F ESHEATH WERE PREPPED AND VALVE WAS DELIVERED OVER A LUNDERQUIST WIRE. POST IMPLANT PRESSURE DECREASED SIGNIFICANTLY, CPR ACLS STARTED. NEW EFFUSION NOTED ON ECHO. POST IMAGES REVEALED A DESCENDING AORTA DISSECTION. CHEST WAS OPENED AND INJURY WAS ATTEMPTED TO BE REPAIRED BY CT SURGEON. HOWEVER, THE PATIENT EXPIRED.

  Patient problems: Aortic dissection; Pericardial Effusion

  MAUDE report 24568758 ↗
• InjuryFeb 26, 2026Difficult or Delayed Positioning

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, THE FIRST 23MM SAPIEN 3 ULTRA RESILIA VALVE DEPLOYED TOO LOW - 20% AORTIC/80% VENTRICULAR ON THE LCC SIDE. THE TOO LOW PLACEMENT WAS DUE TO INCORRECT GANTRY VIEW FOR ALIGNMENT OF NEW VALVE TO NATIVE ANNULUS. A SECOND S3UR VALVE WAS PREPPED FOR IMPLANTATION BUT WAS ABORTED AS THE PASSAGE OF THE DELIVERY SYSTEM PUSHED THE FIRST VALVE INTO THE VENTRICLE. THE FIRST VALVE WAS RETRIEVED FROM THE VENTRICLE USING SNARES AND A BALLOON AND ULTIMATELY SECURED IN THE DESCENDING AORTA. THERE WAS NO ISSUE TRACKING THE SECOND VALVE AND DELIVERY SYSTEM THROUGH THE PATIENT. THERE WAS NO DIFFICULTY CROSSING AS THE SECOND VALVE DID NOT CROSS THE FIRST VALVE. AS THE NOSE CONE OF THE SECOND VALVE AND DELIVERY SYSTEM WAS ADVANCED INTO THE ASCENDING AORTA, FORWARD MOTION OF THIS SECOND DELIVERY SYSTEM, PUSHED THE FIRST VALVE (WHICH WAS CURRENTLY ANCHORED 10-90 IN THE ANNULUS/LVOT) AND RESULTED IN VENTRICULAR EMBOLIZATION OF THE FIRST VALVE. THE SECOND VALVE AND DELIVERY SYSTEM WERE SAFELY REMOVED FROM THE PATIENT AND DISCARDED. THERE ARE NO PLANS FOR FURTHER INFORMATION AS THE PATIENT IS NOW DECEASED. PRIOR TO THE NOTIFICATION OF DEATH, THE PATIENT WAS ON A V

  Patient problems: Insufficient Information

  MAUDE report 24457467 ↗
• MalfunctionFeb 20, 2026Inflation Problem

  PER THE FIELD CLINICAL SPECIALIST, DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE USING A 23 MM SAPIEN 3 ULTRA VALVE, IT APPEARED THAT THE DISTAL STRUTS MAY HAVE MOMENTARILY HUNG-UP DURING DEPLOYMENT. THE DISTAL PORTION OF THE BALLOON BEGAN TO INFLATE INITIALLY BUT SEEMED TO CATCH, WHILE THE PROXIMAL PORTION CONTINUED TO EXPAND. ONCE BALLOON EXPANSION PROGRESSED, THE DISTAL SEGMENT ULTIMATELY FULLY INFLATED. THE POST-DEPLOYMENT ANGIOGRAM SHOWED A WELL POSITIONED VALVE WITH NO PARAVALVULAR LEAK (PVL) AND MINIMAL GRADIENT. THERE WAS NO EVIDENCE OF PVL. AN 85/15 SALINE-TO-CONTRAST MIXTURE WAS USED. MODERATE FORCE WAS REQUIRED TO ADVANCE THE COMMANDER DELIVERY SYSTEM THROUGH THE SHEATH, AS IT APPEARED TO ENCOUNTER SLIGHT RESISTANCE BEFORE EXITING THE DISTAL SHEATH INTO THE ASCENDING AORTA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24406299 ↗
• DeathFeb 20, 2026Difficult to Advance

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, BOTH FEMORAL ACCESSES WAS CALCIFIED AND THERE WERE BILATERAL ILIAC STENTS. HOWEVER, ALTERNATIVE ACCESS WASN'T FEASIBLE. THE VALVE STUCK IN THE RIGHT ILIAC STENT NEAR ILIAC BIFURCATION AFTER IT HAD EXITED THE ESHEATH. THE IMPLANTER TRIED TO NAVIGATE THROUGH IT. LATER, LOOKING AT THE AORTIC AND ILIAC BLEEDING, IMPLANTER DEPLOYED THE VALVE IN THE ABDOMINAL AORTA AND BALLOON TAMPONADE WAS PERFORMED TO STOP BLEEDING. VASCULAR SURGERY TEAM TOOK OVER. LATER, PATIENT PASSED AWAY DUE TO EXCESSIVE BLEEDING. THE ROOT CAUSE OF THE AORTIC AND ILIAC BLEEDING WAS RELATED TO THE PUSHING THE VALVE THROUGH THE STENT. THE VALVE WAS SUCCESSFULLY IMPLANTED. THERE WAS NO CENTRAL LEAK. THERE WAS NO USE ERROR THAT LED TO ANY NEGATIVE OUTCOMES OR PATIENT INJURY. THERE WAS NO DEVICE MALFUNCTION/DIFFICULTY USING THE DEVICE DURING THE CASE.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 24404610 ↗
• InjuryFeb 12, 2026Inflation Problem

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), AN 85'YEAR'OLD MALE PATIENT UNDERWENT A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE USING A RIGHT SIDE ACCESS APPROACH. EDWARDS LIFESCIENCES DEVICES WERE USED DURING THE CASE. THE PATIENT'S PREPROCEDURAL MEDICAL HISTORY AND COMORBIDITIES WERE NOT REPORTED. THE PATIENT REMAINED IN STABLE CONDITION AT THE CONCLUSION OF THE PROCEDURE. DURING DEPLOYMENT OF THE INITIAL 23 MM TRANSCATHETER AORTIC VALVE, THE VALVE BEGAN TO RISE WITHIN THE ANNULUS. THE MOVEMENT OCCURRED DURING VALVE DEPLOYMENT, RESULTING IN THE VALVE BECOMING POSITIONED TOO HIGH AGAINST THE LEFT CORONARY CUSP. THE FIRST VALVE WAS IMPLANTED TOO HIGH ON THE LEFT CUSP DUE TO RISING UP OF THE VALVE DURING IMPLANT, AND THE EXACT REASON FOR THIS MOVEMENT WAS UNKNOWN. AN ATTEMPT BY THE PHYSICIAN TO PUSH THE VALVE DOWNWARD CAUSED THE VALVE TO CANT FURTHER UPWARD, LEADING TO A FINAL MALPOSITION. ANGIOGRAPHIC AND ECHOCARDIOGRAPHIC IMAGING CONFIRMED THAT THE VALVE WAS POSITIONED TOO HIGH TO SERVE AS THE FINAL IMPLANT. BASED ON THE IMAGING FINDINGS, THE SURGEON AND INTERVENTIONAL CARDIOLOGIST DETERMINED THAT A SECOND VALVE WAS REQUIRED. A SECOND TRANSCATHETER AORTIC VALVE

  Patient problems: Insufficient Information

  MAUDE report 24324557 ↗
• MalfunctionFeb 11, 2026Inflation Problem; Failure to Align

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE BY TRANSFEMORAL APPROACH, THE BALLOON INFLATED FROM THE AORTIC SIDE UNEVENLY. THE DEVICE WAS PREPPED NORMALLY. THERE WAS NO TORQUE DURING PROCEDURE. VALVE ALIGNMENT HAD BEEN PERFORMED IN A STRAIGHT SECTION WITH NO DIFFICULTY. THE VALVE WAS SLIGHTLY MIS-ALIGNED ON THE BALLOON BUT IT WAS STILL FELT TO BE WITHIN THE SAFE ZONE TO DEPLOY. THE TEAM WAS ABLE TO CORRECT AND COMPLETE DEPLOYMENT OF THE VALVE WITH A SECOND INFLATION. PER THE PHYSICIAN, THE BALLOON CATHETER WAS LOCKED AND THEY DID NOT PULL BACK ON THE BALLOON AT ALL DURING THE DEPLOYMENT. THIS OPERATOR IS ALSO VERY DELIBERATE WITH DEPLOYMENT, SO THIS WAS NOT A FAST INFLATION. THERE WAS NO WITHDRAWAL DIFFICULTY. THE PATIENT WAS NOT HARMED AND WAS DISCHARGED TO HOME. THERE WAS NO DAMAGE TO THE DEVICE. A VIDEO OF THE FULL DEPLOYMENT WAS PROVIDED. THE DEVICE WILL NOT BE RETURNED. THE PROVIDED FLUORO/CINE IMAGERY WERE REVIEWED, AND THE FOLLOWING WAS OBSERVED: CRIMPED TRANSCATHETER HEART VALVE (THV) NOT FULLY BETWEEN MARKERS PRIOR TO DEPLOYMENT (TOO DISTAL), WITH ASYMMETRICAL INFLATION OBSERVED AS INFLATION OF BALLOON APPEARS CONS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24318999 ↗
• MalfunctionFeb 9, 2026Burst Container or Vessel; Difficult to Remove

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), IT WAS A CASE OF A 23 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH. DURING DEPLOYMENT, THE COMMANDER DELIVERY SYSTEM BALLOON RUPTURED WHILE FULLY INFLATED FOR APPROXIMATELY 4 SECONDS. THE RUPTURE WAS ATTRIBUTED TO CONTACT WITH A SMALL, CALCIFIED SINOTUBULAR JUNCTION (STJ). NO ADDITIONAL VOLUME WAS ADDED. THE SURGEON DID NOT OBSERVE ANY DEFICIENCY IN THE DELIVERY SYSTEM AND BELIEVED THE RUPTURE WAS CAUSED BY THE SHARP CALCIFICATION AT THE STJ. POST-DILATATION WAS NOT REQUIRED, AS THE VALVE APPEARED TO BE FULLY INFLATED WITH NO EVIDENCE OF LEAK. DIFFICULTY WAS ENCOUNTERED DURING WITHDRAWAL, AS THE BALLOON WAS ENTERING THE TIP OF THE SHEATH. THE SURGEON ROTATED THE SHEATH 180 DEGREES, AFTER WHICH THE BALLOON ADVANCED SMOOTHLY. NO OTHER EW DEVICE DAMAGE WAS OBSERVED. THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291841 ↗
• MalfunctionFeb 6, 2026Fluid/Blood Leak

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, DURING A RIGHT TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE TO IMPLANT A 23MM VALVE, RESISTANCE WAS EXPERIENCED ADVANCING THE COMMANDER DELIVERY SYSTEM (DS) THROUGH THE 14F ESHEATH+ (ESP) AND THE DS WAS FOUND TO HAVE A PINHOLE LEAK. DURING THE PROCEDURE, THERE WAS NO RESISTANCE DURING INSERTION OF THE ESP INTO THE PATIENT. THE ESP WAS NOT INSERTED AT A STEEP ANGLE. THERE WAS SOME DIFFICULTY EXPERIENCED ADVANCING THE VALVE THROUGH THE ESP WHEN THE DS WAS IN THE FULLY EXPANDABLE PORTION OF THE ESP. THE VALVE WAS FULLY DEPLOYED, AND NO PATIENT INJURY OCCURRED. POST VALVE DEPLOYMENT AND UPON DEFLATION OF DS BALLOON, BLOOD WAS OBSERVED IN THE ATRION INFLATION DEVICE. THE DS BALLOON REMOVED THROUGH THE ESP WITHOUT ISSUE FROM THE PATIENT AND INFLATED ON THE BACK TABLE. THE BALLOON FOUND TO HAVE PINHOLE PUNCTURE IN PROXIMAL END OF BALLOON CATHETER. THE ESP WAS FOUND TO HAVE A DISTAL TIP TEAR. IT IS NOT KNOWN AT WHAT POINT IN THE PROCEDURE THE DAMAGE OCCURRED. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE. THE DEVICES WERE DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279306 ↗
• MalfunctionFeb 3, 2026Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE BY TRANSFEMORAL APPROACH, THE COMMANDER DELIVERY SYSTEM BALLOON BURST ON DEPLOYMENT DUE TO PATIENT ANATOMY. THE DELIVERY SYSTEM WAS PREPARED IN STANDARD PROCEDURE AND WAS USED IN NORMAL CIRCUMSTANCE, SO CUSTOMER SUSPECTS IT WAS DUE TO CALCIUM AT THE SINOTUBULAR JUNCTION, AND NO OTHER REASON IS SUSPECTED. UPON EYE INSPECTION, THE BALLOON HAD A VERTICAL TEAR CONSISTENT WITH WHAT WAS OBSERVED ON CT. THEY WERE ABLE TO DEPLOY 16CC FROM THE END DEFLATOR BEFORE IT BURST. POST DILATION WAS PERFORMED DUE TO PERIVALVULAR LEAK. THE VALVE WAS SUCCESSFULLY IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24254509 ↗

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