{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Miami Lakes",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "93405",
      "recalling_firm": "Heartware, Inc.",
      "address_1": "14400 Nw 60th Ave",
      "address_2": "",
      "postal_code": "33014-2807",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Worldwide",
      "recall_number": "Z-0482-2024",
      "product_description": "HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205",
      "product_quantity": "126 units",
      "reason_for_recall": "Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components",
      "recall_initiation_date": "20231031",
      "center_classification_date": "20231201",
      "report_date": "20231213",
      "code_info": "Serial numbers:  HW1412, HW1413, HW1416, HW1433, HW1435, HW1490, HW1493, HW1495, HW1496, HW1593, HW1599, HW1641, HW1661, HW1662, HW1663, HW1664, HW1695, HW1696, HW1698, HW1699, HW1706, HW1708, HW1709, HW1718, HW1727, HW1730, HW1740, HW1741, HW1747, HW1754, HW1760, HW1764, HW1765, HW1768, HW1773, HW1774, HW1777, HW1778, HW1783, HW1785, HW1796, HW1804, HW1808, HW1810, HW1811, HW1815, HW1819, HW1821, HW1822, HW1823, HW1824, HW1825, HW1826, HW1828, HW1830, HW1831, HW1832, HW1839, HW1841, HW1856, HW1857, HW1876, HW1879, HW1882, HW1884, hw1895, HW1896, HW1897, HW1899, HW1900, HW1901, HW1905, HW1906, HW1907, HW1908, HW1913, hw1914, HW1917, HW1920, HW1921, HW1922, HW1923, HW1924, HW1925, HW1926, HW1927, HW1928, HW1929, HW1930, HW1931, HW1933, HW1934, HW1935, HW1936, HW1937, HW1938, HW1939, HW1940, HW1941, HW1942, HW1943, hw1944, HW1947, HW1950, HW1952, HW1960, HW1961, HW1962, HW1964, HW1965, HW1966, HW1967, HW1968, HW1969, HW1970, HW1971, HW1972, HW1973, HW1974, HW1976, HW1977, HW1978, HW1979, HW1983, HW2023, HW2028",
      "more_code_info": ""
    }
  ]
}