EDWARDS COMMANDER DELIVERY SYSTEM 9600LDS23Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00690103193947), received between Sep 12, 2018 and Jan 9, 2024 — classified as 1 death, 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (3 reports).

1 FDA recall record name this device's identifier.

2 other recalls cover devices cleared under the same FDA submission (P140031, P200015); 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.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2024Positioning Problem; Positioning Problem

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A JUGULAR TPVR PROCEDURE WITH A 23MM SAPIEN 3 VALVE IN A CONDUIT, THE VALVE WAS OBSERVED TO BE MIGRATING PROXIMALLY DURING INFLATION OF THE COMMANDER DELIVERY SYSTEM, MISSING THE INTENDED LANDING ZONE. THE VALVE WAS OBSERVED TO BE STABLE IN THE ANATOMY. THE COMMANDER DELIVERY SYSTEM WAS REMOVED, AND A PIGTAIL CATHETER WAS ADVANCED TO THE RIGHT PULMONARY ARTERY. AN ANGIOGRAPYHY WAS PERFORMED, AND MODERATE PARAVALVULAR LEAK WAS NOTED. THERE WAS DISCUSSION REGARDING PLACEMENT OF A SECOND VALVE DISTAL TO THE INITIAL, HOWEVER, DUE TO THE LENGTH OF THE PROCEDURE AND THE RADIATION EXPOSURE, THE CASE WAS COMPLETED, AND THE TEAM WOULD DISCUSS FUTURE VALVE IN VALVE OR SURGICAL REINTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18481083 ↗
• InjuryMar 30, 2023Material Rupture; Material Rupture

  PER THE TERRITORY MANAGER (TM), DURING A TAVR PROCEDURE USING A 23MM SAPIEN 3 VALVE VIA TRANSFEMORAL APPROACH, WHEN DEPLOYING THE FIRST VALVE, THE BALLOON RUPTURED DURING INFLATION WITH THE VALVE PARTIALLY DEPLOYED. THE VALVE WAS BROUGHT DOWN TO A SUPRARENAL POSITION IN THE DESCENDING AORTA. A 20MM TRUE BALLOON WAS USED TO INFLATE THE VALVE AND IT WAS DETERMINED IT WAS IN A SAFE AND SECURE LOCATION. A SECOND VALVE WAS PREPPED AND PLACED IN THE ANNULUS OF THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE WELL AND THE VALVE WAS WORKING PROPERLY. NO COMPLICATIONS TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16643950 ↗
• InjurySep 7, 2021Burst Container or Vessel; Burst Container or Vessel

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT DURING A PULMONIC TAVR IN A PREVIOUS SURGICAL VALVE, TWO 9600TFX SAPIEN 3 23 MM VALVES WERE IMPLANTED.AS REPORTED, THE FIRST VALVE WAS DEPLOYED WAS POST DILATED WITH A 20 MM ATLAS BALLOON. THIS CAUSED A 'FLAIL' LEAFLET. THE LEAFLET LOOKED TORN. A SECOND VALVE 9600TFX SAPIEN 3 23 MM VALVE WAS REQUIRED AND DURING DEPLOYMENT, THE COMMANDER BALLOON RUPTURED CAUSING THE PREEXISTING CONDUIT TO DEHISCED AT THE DISTAL SUTURES THE PATIENT WAS TAKEN TO SURGERY TO REPAIR. PATIENT IS STABLE AND RECOVERING IN ICU.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 12436121 ↗
• MalfunctionApr 16, 2021Material Rupture; Material Split, Cut or Torn

  EDWARDS RECEIVED NOTIFICATION FROM A TERRITORY MANAGER, THAT A BALLOON RUPTURED OCCURRED DURING VALVE DEPLOYMENT. AS REPORTED, THE ACCESS WAS VIA THE TRANSFEMORAL APPROACH. THE AORTIC VALVE WAS ONLY MILDLY CALCIFIED BUT THERE WAS A RING OF CALCIUM NOTED IN THE SINOTUBULAR JUNCTION (STJ). THE BALLOON RUPTURED DURING VALVE DEPLOYMENT WITHOUT CONSEQUENCE TO THE PATIENT. THE BALLOON WAS RECOVERED THROUGH THE SHEATH WITHOUT INCIDENT. THE TRANSCATHETER VALVE APPEARED FULLY DEPLOYED ANGIOGRAPHICALLY. THERE WAS NO PARAVALVULAR LEAK AND THE GRADIENT WAS LOW SO IT WAS DECIDED NOT TO POST DILATE. THERE WAS NO HARM TO THE PATIENT. PER FOLLOW-UP IT WAS NOTED THAT, THE BALLOON WAS FULLY OR NEAR AS A SECOND INFLATION WAS NOT NEEDED. A BAV WAS NOT USED. 1CC WAS ADDED AS THE PATIENT WAS AT THE UPPER END OF THE 23 RANGE ON THEIR MEASUREMENTS. THE SURGEON THOUGHT IT BURST MUCH EARLIER AS THERE WAS VIRTUALLY NO RESISTANCE. IT WAS THOUGH THAT THIS WAS LIKELY DUE TO THE MILD CALCIFICATION IN THE CUSPS. A LINEAR TEAR THE FULL LENGTH OF THE BALLOON WAS FOUND. THE DEVICE IS NOT AVAILABLE FOR RETURN AND NO PICTURES ARE AVAILABLE.

  Patient problems: Calcium Deposits/Calcification; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11682824 ↗
• DeathMar 23, 2021Difficult to Advance; Difficult to Advance

  AS REPORTED, THE PATIENT PREVIOUSLY HAD A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A NON EDWARDS VALVE WHICH MIGRATED INTO THE ASCENDING AORTA. THE PATIENT RETURNED TO THE HOSPITAL TO BE TREATED WITH A 23MM SAPIEN 3 VALVE. UPON ADVANCING THE COMMANDER DELIVERY SYSTEM THROUGH THE STENT STRUTS OF THE PREVIOUSLY IMPLANTED VALVE, THE NON EDWARDS VALVE MIGRATED INTO THE AORTIC ROOT. AN AORTIC DISSECTION OCCURRED. THE SAPIEN 3 VALVE WAS NOT DEPLOYED. UPON REMOVAL OF THE SYSTEM, THE NON EDWARDS VALVE WAS PULLED BACK INTO THE ASCENDING AORTA. THE SYSTEM WAS REMOVED. A LARGE PERICARDIAL EFFUSION WAS NOTED, AND THE PATIENT EXPIRED IN THE PROCEDURE ROOM.

  Patient problems: Great Vessel Perforation

  MAUDE report 11554753 ↗
• InjurySep 12, 2018Break; Material Rupture

  DURING DEPLOYMENT OF THE VALVE, THE TRANSCATHETER AORTIC VALVE BALLOON RUPTURED AT MAXIMUM PRESSURE. THE PHYSICIAN ATTEMPTED TO REMOVE THE DELIVERY SYSTEM, BUT DUE TO THE RUPTURED BALLOON, THE SHEATH WAS DAMAGED. SURGICAL CUT DOWN AND REPAIR OF THE RIGHT SUPERFICIAL FEMORAL ARTERY WAS DONE. FLUORO OF THE BILATERAL GROINS SHOWED A SMALL PIECE OF THE DELIVERY SYSTEM EMBOLIZED TO A SMALL BRANCH OF THE FEMORAL ARTERY. CUT DOWN OF THE LEFT SFA AND PROFUNDA FEMORIS ARTERY WAS PERFORMED, BUT THE EMBOLIZED PIECE COULD NOT BE RETRIEVED. THE PT HAD NO FURTHER COMPLICATIONS AND MAINTAINED NORMAL DISTAL PULSES.

  Patient problems: Embolism

  MAUDE report 7872853 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140031, P200015. One submission often covers many models, so check the product and lot details in each record.

• 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