{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "77802",
      "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": "Worldwide Distribution - US Nationwide GB, NL, DE, IT, FR, BE, ES, NO, CZ, BG, SE, AT, CH, PL, RU, FI",
      "recall_number": "Z-3077-2017",
      "product_description": "Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806    Product Usage:  The Fogarty adherent clot catheters are designed to effectively remove clot material in the peripheral vasculature. The catheters are indicated for the removal of emboli and thrombi from native arteries or synthetic grafts. The device are designed to facilitate clots too resistant to be removed by an elastomeric balloon. The device features a spiral-shaped, latex-covered stainless steel cable that assumes a corkscrew shape when retracted, greatly expanding the surface areas to entrap fibrous material. The device is 80 cm in length and is available in 4F-6F diameters.",
      "product_quantity": "200 units",
      "reason_for_recall": "The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm.",
      "recall_initiation_date": "20170706",
      "center_classification_date": "20170825",
      "termination_date": "20181017",
      "report_date": "20170906",
      "code_info": "Lots 60439817 and 60439818"
    }
  ]
}