{
  "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": "2026-04-08",
    "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": "80056",
      "recalling_firm": "Heartware",
      "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 including US Nationwide, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kazakhstan, Korea, , Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, and Vietnam.",
      "recall_number": "Z-1903-2018",
      "product_description": "Heartware Medtronic  HVAD System for cardiac use.  Including the following parts:  (a) Controller / Controller Kits, Product numbers: 1400, 1401, 1403, 1407, 1420  (b) DC Adapter, Product numbers: 1435, 1440  (c) AC Adapter, Product numbers:  1425, 1430  (d) Battery Pack, Product number:  1650DE      Indication for Use for OUS HVAD System: The HVAD System is intended for use in patients at risk of death from refractory end-stage heart failure. The HVAD System is designed for in-hospital and out-of-hospital settings, including transportation via fixed wing aircraft or helicopter.",
      "product_quantity": "175878 devices",
      "reason_for_recall": "Possible transient electrical connection interruption between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the Controller, while the power source is connected, that may cause unintended switching to the secondary power source and/or unexpected audible tones (beeping). The interruption typically lasts 1-2 seconds, due to oxidation between power source connector and socket.",
      "recall_initiation_date": "20180502",
      "center_classification_date": "20180531",
      "report_date": "20180606",
      "code_info": "ALL SERIAL NUMBERS    UPN/GTIN:  (a) 1400 and 1401:  distributed prior to GTN requirement        1403: 00888707000116, 00888707000475        1407: '00888707000291, '00888707000727, '00888707000710,    00888707000734, '00888707000741, '00888707000765, '00888707000758, '00888707000789, '00888707000772, '00888707000499, '00888707000796, '00888707000802, '00888707000819, '00888707000482, '00888707004534, '0888707001670, '00888707001656, '00888707001663, '00888707001670, '00888707001687, '00888707001694, '00888707001700, '00888707001717, '00888707001724, '00888707001731, '00888707001748, '00888707001755, '00888707001762, '00888707002813, '00888707002820, '00888707002837, '00888707002844, '00888707002851, '00888707001472        1420: '00888707000420, '00888707000437, '00888707002660    (b) 1435:  '00888707000109       1440:  '00888707000260, '00888707001885, '00888707001496,   '00888707002745    (c) 1425:  '00888707000093       1430: '00888707000307, '00888707000826, '00888707000833,   '00888707000840, '00888707000857, '00888707000871, '00888707000864,   '00888707000888, '00888707000901, '00888707000505, '00888707000895,   '00888707000918, '00888707001489, '00888707001779, '00888707001786,   '00888707001793, '00888707001809, '00888707001816, '00888707001823,   '00888707001830, '00888707001847, '00888707001854, '00888707001861,   '00888707001878, '00888707002738, '00888707002769, '00888707002776,   '00888707002783, '00888707002790, '00888707002806, '00888707004817    (d) 1650DE:  00888707000369, 00888707001373, '00888707001588,  '00888707001366, '00888707002684 '00888707002646, '00888707002653,   '00888707000376"
    }
  ]
}