{
  "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": [
    {
      "country": "United States",
      "city": "Fairfield",
      "address_1": "15 Law Dr",
      "reason_for_recall": "Maquet/Getinge is initiating a voluntary product removal involving four lot numbers of SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK since during internal pressure (leak) testing of the SENSATION PLUS 8Fr. 50cc, IABC, failures related to the tip seal leak were identified.",
      "address_2": "",
      "product_quantity": "996 UNITS",
      "code_info": "300004515,   3000043376  3000040272  3000038372    added lot numbers:    3000043374 and 3000045513",
      "center_classification_date": "20170525",
      "distribution_pattern": "Nationwide",
      "state": "NJ",
      "product_description": "SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ Product Code/Part Number:  0684-00-0576-01U is a cardiac assist device which support the heart's left ventricle by increasing coronary perfusion and reducing the work of the left ventricle.",
      "report_date": "20170531",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Datascope Corporation",
      "recall_number": "Z-2164-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "76942",
      "termination_date": "20200128",
      "more_code_info": "",
      "recall_initiation_date": "20170412",
      "postal_code": "07004-3206",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}