EDWARDS COMMANDER DELIVERY SYSTEM 9600LDS20Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00690103193930), received between Sep 9, 2021 and Oct 21, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jan 22, 2019Terminated

   This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.

   Z-0835-2019 · Root cause: Labeling design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2025Crack; Crack

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, REGARDING A 20MM SAPIEN 3 VALVE IN THE MITRAL POSITION. WHEN THE 20MM SAPIEN 3 VALVE AND 20MM COMMANDER DELIVERY SYSTEM WERE INSERTED INTO THE GORE DRYSEAL, THE IMPLANTING PHYSICIAN SAID HE FELT A CRACK IN THE COMMANDER DELIVERY SYSTEM CATHETER. UPON REMOVAL OF THE FIRST DELIVERY SYSTEM AND VALVE, IT WAS NOTICED THAT ALL THE FLEX WAS NOT TAKEN BACK OUT OF THE DELIVERY SYSTEM. THERE WAS NO PATIENT INJURY. A SECOND 20MM SAPIEN 3 VALVE AND 20MM COMMANDER DELIVERY SYSTEM WERE USED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347669 ↗
• InjuryMay 14, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 3 YEARS, 2 MONTHS, AND 23 DAYS POST-IMPLANT OF A 20 MM SAPIEN 3 (S3) VALVE IN THE MITRAL POSITION, THE 20 MM SAPIEN 3 VALVE WAS NOTED TO BE STENOTIC. THE MEAN INFLOW GRADIENTS WERE BETWEEN 12-15MMG. DUE TO THE PATIENT'S HISTORY, THIS WAS FOUND ON A ROUTINE EXAM WHICH THE ECHO REVEALED BI-ATRIAL ENLARGEMENT ALSO. DURING THE VALVE IN VALVE CASE, THE IMPLANTING CARDIOLOGIST (IC) AND TEAM HAD DIFFICULTY POSITIONING THE NEW 20MM S3 INSIDE OF THE EXISTING 20MM S3. IT APPEARED THAT THE IC COULD NOT GET IT COAXIAL ENOUGH TO FULLY CROSS AND POSITION APPROPRIATELY AND WHEN PUSHING ON THE COMMANDER DELIVERY SYSTEM, AT ONE POINT, THE VALVE APPEARED TO 'JUMP' FORWARD INTO THE LEFT VENTRICLE (LV). THE WORKING WIRE (SAFARI EXTRA SMALL) MAY HAVE JUMPED FORWARD ALSO. THE TEAM PULLED THE NEW S3 VALVE BACK, NEARLY TO AN ACCEPTABLE POSITION TO DEPLOY, BUT THEN IT MOVED TOO ATRIAL. THEY CONTINUED TO STRUGGLE TO CROSS THE EXISTING VALVES (THE PREVIOUS 20MM S3 WAS ALREADY INSIDE OF A 23MM EPIC SUPRA THAT WAS PLACED IN 2018). SOMEWHERE NEAR THIS POINT IN TIME WE NOTICED THE PATIENT'S BLOOD PRESSURE BEGAN TO DECLINE. THE HEART RHYTHM CHANGED

  Patient problems: Cardiac Perforation

  MAUDE report 22022497 ↗
• MalfunctionDec 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL VEIN TTVR PROCEDURE WITH A 20 MM SAPIEN 3 VALVE IN A PRE-EXISTING SURGICAL VALVE IMPLANTED 2 YEARS AGO, THE COMMANDER DELIVERY SYSTEM DID NOT FILL DURING VALVE DEPLOYMENT. PER REPORT, THERE WAS A HOLE IN THE BALLOON. THE COMMANDER DELIVERY SYSTEM AND VALVE WAS INSERTED INTO THE ESHEATH+. THE TEAM ATTEMPTED TO LOAD THE VALVE ON THE STRAIGHTEST PART, AND WAS ABLE TO, HOWEVER, WHEN IT WAS TIME TO DEPLOY THE VALVE, THE BALLOON DID NOT FILL DUE TO A HOLE IN THE BALLOON. IT IS BELIEVE THAT THE HOLE WAS FROM LOADING ON A TURN. THE DELIVERY SYSTEM, AND VALVE WERE PULLED BACK INTO THE ESHEATH+ AND REMOVED AS A UNIT. A NEW KIT WAS PREPPED, AND THE VALVE WAS IMPLANTED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15992623 ↗
• MalfunctionJan 2, 2022Burst Container or Vessel; Burst Container or Vessel

  PER THE FIELD CLINICAL SPECIALIST (FCS), DURING A TAVR PROCEDURE FOR A 20MM SAPIEN 3 IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH, THE BALLOON BURST DURING DEPLOYMENT. POST DEPLOYMENT OF THE VALVE THE PATIENT HAD CENTRAL REGURGITATION. A SECOND THV VALVE WAS DEPLOYED AND WORKED FINE INITIALLY, HOWEVER PATIENT WAS PRESENTING HIGH GRADIENT. THE OPERATOR POST DILATATED THE VALVE AND RESULTED IN CENTRAL REGURGITATION ON ANGIO. TO RESOLVE THE ISSUE THE TEAM ELECTED TO PLACE A NON-EDWARDS VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13139246 ↗
• InjurySep 9, 2021Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  AS REPORTED BY AND EDWARDS LIFESCIENCES AFFILIATE, REGARDING A 20MM SAPIEN 3 VALVE IN A PRE-EXISTING NON-EDWARDS STENTED VALVE VIA THE LEFT FEMORAL VEIN USING A NON-EDWARDS SHEATH (18F), WHEN THE 20MM COMMANDER DELIVERY SYSTEM BALLOON WAS ATTEMPTED TO BE INFLATED THE BALLOON LEAKED AND DID NOT INFLATE. ALL THE DEVICES (DELIVERY SYSTEM, VALVE, NON-EDWARDS SHEATH) WERE ATTEMPTED TO BE REMOVED AS A UNIT. RESISTANCE DURING WITHDRAWAL WAS ENCOUNTERED AND THE VALVE, DELIVERY SYSTEM NOSE CONE AND PART OF THE BALLOON SEPARATED FROM THE DELIVERY SYSTEM CATHETER. A SURGICAL CUTDOWN WAS DONE AND ALL COMPONENTS WERE RETRIEVED. A LARGER NON-EDWARDS SHEATH (24F) WAS INSERTED AND A SECOND 20MM SAPIEN 3 VALVE AND 20MM COMMANDER DELIVERY SYSTEM WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE LEFT FEMORAL VEIN WAS REPAIRED AND THE PATIENT WAS TRANSFERRED TO THE UNIT IN STABLE CONDITION..

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12450985 ↗