{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "83293",
      "recalling_firm": "Edwards Lifesciences, LLC",
      "address_1": "1 Edwards Way",
      "address_2": "N/A",
      "postal_code": "92614-5688",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US: VA, CA, GA, MA, MD, NY, OR, WA, MN, TN, AL, KS  OUS: United Kingdom, Switzerland, Sweden, Spain, Portugal, Poland, Norway, Netherlands, Italy, Ireland, Germany,  Finland, Denmark, Canary Islands, Canada, Austria",
      "recall_number": "Z-2224-2019",
      "product_description": "Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System)  (20 mm) 9630TF20   UDI:00690103201239",
      "product_quantity": "362 units",
      "reason_for_recall": "The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures",
      "recall_initiation_date": "20190709",
      "center_classification_date": "20190821",
      "termination_date": "20200915",
      "report_date": "20190828",
      "code_info": "All Lots"
    }
  ]
}