{
  "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": "Miami Lakes",
      "state": "FL",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85397",
      "recalling_firm": "Heartware, Inc.",
      "address_1": "14400 Nw 60th Ave",
      "address_2": "N/A",
      "postal_code": "33014-2807",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution",
      "recall_number": "Z-2057-2020",
      "product_description": "Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP",
      "product_quantity": "85 units",
      "reason_for_recall": "The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.",
      "recall_initiation_date": "20200403",
      "center_classification_date": "20200522",
      "report_date": "20200603",
      "code_info": "GTIN 00888707000697, Serial numbers:  HW34700, HW34703, HW34710, HW34713    GTIN 00888707005838, Serial Numbers:  HW40383, HW40412, HW40413, HW40414, HW40415, HW40417, HW40418, HW40419, HW40420, HW40421, HW40422, HW40423, HW40424, HW40425, HW40426, HW40428, HW40429, HW40431, HW40465, HW40471, HW40472, HW40473, HW40474, HW40475, HW40476, HW40477, HW40478, HW40479, HW40480, HW40552, HW40553, HW40554, HW40555, HW40556, HW40557, HW40564, HW40565, HW40580, HW40599, HW40600, HW40602, HW40603, HW40604, HW40607, HW40609, HW40611, HW40612, HW40613, HW40649, HW40650, HW40651, HW40652, HW40653, HW40655, HW40656, HW40657, HW40658, HW40659, HW40660, HW40661, HW40662, HW40663, HW40664, HW40666, HW40667, HW40668, HW40789, HW40816, HW40881, HW40950, HW40951, HW40952, HW40953, HW40954, HW40955, HW40956, HW40957, HW40958, HW40960, HW40961, HW41045"
    }
  ]
}