{
  "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": "2026-04-01",
    "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": "90079",
      "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": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Finland and Turkey",
      "recall_number": "Z-1107-2022",
      "product_description": "HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets:\t  HVAD¿ System Emergency Responder Guide (FI-Finnish)  HVAD¿ System Emergency Responder Guide (FI-Finnish)  HVAD¿ System Emergency Responder Guide (FI-Finnish)  HVAD¿ System Emergency Responder Guide (FI-Finnish)  HVAD¿ System Instructions For Use (FI)  HVAD¿ System Instructions For Use (FI)  HVAD¿ System Patient Manual (FI-Finnish)  HVAD¿ System Patient Manual (FI-Finnish)  HVAD¿ System Patient Manual (FI-Finnish)  HVAD¿ System Patient Manual (FI-Finnish)  HVAD¿ System Patient Manual (FI-Finnish)  HVAD¿ System Patient Manual (FI-Finnish)  HVAD¿ System Patient Manual (FI-Finnish)  HVAD¿ System Patient Manual (FI-Finnish)  HVAD¿ System Patient Manual (FI-Finnish)  HVAD¿ System Instructions For Use - FI  HVAD¿ System Instructions For Use (FI)  HVAD¿ System OUS Patient Manual (FI-Finnish)  HVAD¿ System Emergency Responder Guide (TR-Turkish)  HVAD¿ System Patient Manual (TR-Turkish)  HVAD¿ System Patient Manual (TR-Turkish)  HVAD¿ System Patient Manual (TR-Turkish)  HVAD¿ System Patient Manual (TR-Turkish)  HVAD¿ System OUS Instructions For Use (TR-Turkish)",
      "product_quantity": "645 units",
      "reason_for_recall": "Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.",
      "recall_initiation_date": "20220330",
      "center_classification_date": "20220517",
      "report_date": "20220525",
      "code_info": "No GTIN  HVAD System Emergency Responder Guide (FI-Finnish), Lot Number:  R020776   HVAD System Emergency Responder Guide (FI-Finnish), Lot Number:  R020776   HVAD System Emergency Responder Guide (FI-Finnish), Lot Number:  R020776   HVAD System Emergency Responder Guide (FI-Finnish), Lot Number:  R025893   HVAD System Instructions For Use (FI), Lot Number:  R020771   HVAD System Instructions For Use (FI), Lot Number:  R020771   HVAD System Patient Manual (FI-Finnish), Lot Number:  R020769   HVAD System Patient Manual (FI-Finnish), Lot Number:  R020769   HVAD System Patient Manual (FI-Finnish), Lot Number:  R020769   HVAD System Patient Manual (FI-Finnish), Lot Number:  R020769   HVAD System Patient Manual (FI-Finnish), Lot Number:  R020769   HVAD System Patient Manual (FI-Finnish), Lot Number:  R020769   HVAD System Patient Manual (FI-Finnish), Lot Number:  R021391   HVAD System Patient Manual (FI-Finnish), Lot Number:  R021391   HVAD System Patient Manual (FI-Finnish), Lot Number:  R022265   HVAD System Instructions For Use - FI, Lot Number:  R025606   HVAD System Instructions For Use (FI), Lot Number:  R028504   HVAD System OUS Patient Manual (FI-Finnish), Lot Number:  R028100   HVAD System Emergency Responder Guide (TR-Turkish), Lot Number:  R025877   HVAD System Patient Manual (TR-Turkish), Lot Number:  R021248   HVAD System Patient Manual (TR-Turkish), Lot Number:  R021248   HVAD System Patient Manual (TR-Turkish), Lot Number:  R027179   HVAD System Patient Manual (TR-Turkish), Lot Number:  R027179   HVAD System OUS Instructions For Use (TR-Turkish), Lot Number:  R025760R01",
      "more_code_info": ""
    }
  ]
}