{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "67815",
      "recalling_firm": "Maquet Datascope Corp - Cardiac Assist Division",
      "address_1": "1300 MacArthur Blvd.",
      "address_2": "N/A",
      "postal_code": "07430-2052",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) and approximately 104 countries.",
      "recall_number": "Z-1523-2014",
      "product_description": "Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump.     The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.",
      "product_quantity": "11,881 units (US 5183 and OUS 6698)",
      "reason_for_recall": "Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning.",
      "recall_initiation_date": "20140321",
      "center_classification_date": "20140521",
      "termination_date": "20180320",
      "report_date": "20140528",
      "code_info": "IABP Model Numbers  System 98 0998-00-0446-xx 0998-UC-0446-xx  System 98XT 0998-00-0479-xx 0998-UC-0479-xx  CS100i 0998-UC-0446Hxx 0998-UC-0479Hxx  CS100  0998-00-3013-xx 0998-UC-3013-xx  CS300 0998-00-3023-xx 0998-UC-3023-xx"
    }
  ]
}