{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "69863",
      "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",
      "recall_number": "Z-1062-2015",
      "product_description": "CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units.  Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx    An electromechanical system used to inflate and deflate intra-aortic balloons.",
      "product_quantity": "838 units-US; 364 units - OUS",
      "reason_for_recall": "Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration units. If fiber-optic connector is inserted into the Maquet CS300 or CARDIOSAVE IABP, cap will prevent connection of unit and may become dislodged and remain in IABPs fiber-optic receptacle.",
      "recall_initiation_date": "20141216",
      "center_classification_date": "20150206",
      "termination_date": "20170609",
      "report_date": "20150218",
      "code_info": "Sensation 7 fr.34 cc IAB Demonstration Unit    0684-DC-0433  0684-DO-0433  0684-DC-0469  0684-DO-0469    Sensation 7 Fr. 40 cc IAB Demonstration Unit  0684-DC-0434  0684-DO-0434  0684-DC-0470  0684-DO-0470    Sesnsation Plus 7.5 Fr. 40cc IAB Demonstration Units   0684-DC-0567  0684-DO-0567  0684-DC-0568  0684-DO-0568    Sensation Plus 7.5 Fr. 50cc IAB Demonstration Units  0684-DC-0575  0684-DO-0575  0684-DC-0576  0684-DO-0576    Sensation Plus 8 Fr. 50 cc IAB Demonstration Unit  0684-DC-0272  0684-DO-0272"
    }
  ]
}