{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "170314",
      "product_res_number": "Z-0835-2019",
      "event_date_initiated": "2019-01-22",
      "event_date_created": "2019-02-14",
      "recall_status": "Terminated",
      "event_date_terminated": "2019-03-26",
      "res_event_number": "81924",
      "product_code": "NPT",
      "pma_numbers": [
        "P140031"
      ],
      "product_description": "Edward Lifesciences, Edwards Commander Delivery System:\nModel Number\tUDI Number\n9600LDS20A (US)\t00690103193930\n9600LDS20J\t00690103194852\n9600LDS23A (US)\t00690103193947\n9600LDS23J\t00690103194869\n9600LDS26A (US)\t00690103193954\n9600LDS26J\t00690103194876\n9600LDS29A (US)\t00690103193961\n9600LDS29J\t00690103194883\n9610TF20\t00690103192995\n9610TF23\t00690103190458\n9610TF26\t00690103190465\n9610TF29\t00690103193008\n\n\nProduct Usage:\nThe Edwards SAPIEN 3 THV, Edwards Commander delivery system and accessories are indicated for use in patients with severe, symptomatic, calcific aortic stenosis",
      "code_info": "(ALL LOTS Model Number\tUDI Number 9600LDS20A (US)\t00690103193930 9600LDS20J\t00690103194852 9600LDS23A (US)\t00690103193947 9600LDS23J\t00690103194869 9600LDS26A (US)\t00690103193954 9600LDS26J\t00690103194876 9600LDS29A (US)\t00690103193961 9600LDS29J\t00690103194883 9610TF20\t00690103192995 9610TF23\t00690103190458 9610TF26\t00690103190465 9610TF29\t00690103193008",
      "firm_fei_number": "1713910",
      "recalling_firm": "Edwards Lifesciences, LLC",
      "address_1": "12050 S Lone Peak Pkwy",
      "city": "Draper",
      "state": "UT",
      "postal_code": "84020-9414",
      "additional_info_contact": "Sarah Huoh\n949-250-6864",
      "reason_for_recall": "This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.",
      "root_cause_description": "Labeling design",
      "action": "The firm began disseminating the notices by letter on 01/22/2019.  The notices explained the issue and advised the consignee to follow the guidelines and instructions provided in the Edward SAPIEN3 Commander delivery system training material for device preparation and use.\n\nUpdated instructions for use will be disseminated in the near future.",
      "product_quantity": "159,448 units",
      "distribution_pattern": "WorldwideDistribution",
      "openfda": {
        "pma_number": [
          "P130021",
          "P190023",
          "P130009",
          "P100041",
          "P140031",
          "P180029",
          "P250024",
          "P110021"
        ],
        "registration_number": [
          "3010432890",
          "3012148004",
          "3007113487",
          "2011171",
          "3010421104",
          "3015287573",
          "3012179728",
          "9617601",
          "2025587",
          "1721676",
          "1928237",
          "3008500478",
          "3014918977",
          "3009420598",
          "2135147",
          "3011894841",
          "3002807314",
          "3005012805",
          "3017298588",
          "3009380063",
          "3007063218",
          "2015691",
          "3005941719",
          "9612164",
          "3044156918"
        ],
        "fei_number": [
          "3010432890",
          "3012148004",
          "3007113487",
          "2011171",
          "3010421104",
          "3015287573",
          "3012179728",
          "3005334138",
          "3002534070",
          "2025587",
          "1721676",
          "1928237",
          "3014918977",
          "3009420598",
          "3002806434",
          "3011894841",
          "3002807314",
          "3005012805",
          "3017298588",
          "3009380063",
          "3007063218",
          "3002807111",
          "1713910",
          "2015691",
          "3044156918"
        ],
        "device_name": "Aortic Valve, Prosthesis, Percutaneously Delivered",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}