{
  "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": "2026-04-08",
    "results": {
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  "results": [
    {
      "country": "United States",
      "city": "Fairfield",
      "address_1": "15 Law Dr",
      "reason_for_recall": "The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.",
      "address_2": "",
      "product_quantity": "12744",
      "code_info": "0684 00 0296 01U and 0684 00 0296 02U",
      "center_classification_date": "20180416",
      "distribution_pattern": "US Nationwide Distribution",
      "state": "NJ",
      "product_description": "Intra-Aortic Balloon Catheter Mega 8FR 50cc  Product Usage:  The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.",
      "report_date": "20180425",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Datascope Corporation",
      "recall_number": "Z-1385-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "79646",
      "termination_date": "20200318",
      "more_code_info": "",
      "recall_initiation_date": "20180221",
      "postal_code": "07004-3206",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
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}