{
  "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": "Columbia",
      "state": "MD",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "75632",
      "recalling_firm": "Elana, Inc.",
      "address_1": "10480 Little Patuxent Pkwy Ste 400",
      "address_2": "N/A",
      "postal_code": "21044-3576",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide Distribution - US including NY and Internationally to Switzerland and the Netherlands.",
      "recall_number": "Z-0698-2017",
      "product_description": "Elana Surgical KitHUD  The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity",
      "product_quantity": "4",
      "reason_for_recall": "Elana has issued this Field Action to voluntarily remove specific serial numbers of our Elana Surgical KitHUD due to potentially compromised integrity of the outer sterile packaging of the Elana Catheter 2.0.",
      "recall_initiation_date": "20161109",
      "center_classification_date": "20161202",
      "termination_date": "20161220",
      "report_date": "20161214",
      "code_info": "Manufacturer\u0019s Product Number, 801-H    Lot/Serial Number, 160301"
    }
  ]
}