{
  "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": "Ongoing",
      "city": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "77877",
      "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 - US Nationwide   International: AFGHANISTAN, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA,  AZERBAIJAN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOSNIA-HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CAMBODIA, CANADA, CHILE,  CHINA, COLOMBIA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT,  EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY,  GREECE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY,  ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN,  JORDAN, KAZAKHSTAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, LIBYA,  LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MALDIVES, MALTA,  MAURITIUS, MEXICO, MOROCCO, MYANMAR, NEPAL, NETHERLANDS,  NEW ZEALAND, NORTH KOREA, NORWAY, OMAN, PAKISTAN, PALESTINE,  PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR,   ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN,  SWITZERLAND, SYRIA, TAIWAN, TANZANIA, THAILAND, TRINIDAD, TUNISIA,  TURKEY, TURKMENISTAN, UGANDA, UKRAINE, UNITED ARAB EMIRATES,   UNITED KINGDOM, URUGUAY, UZBEKISTAN, VENEZUELA, VIETNAM &  YEMEN.",
      "recall_number": "Z-3087-2017",
      "product_description": "CS 300 Intra-Aortic Balloon Pump.    It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle.",
      "product_quantity": "14,547 units (5,049 domestically & 9,498 units internationally)",
      "reason_for_recall": "False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy.",
      "recall_initiation_date": "20170717",
      "center_classification_date": "20170905",
      "report_date": "20170913",
      "code_info": "0998-XX-3023-XX; 0998-UC-3023-XX"
    }
  ]
}