{
  "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": "2026-08-15",
    "results": {
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  "results": [
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      "cfres_id": "167142",
      "product_res_number": "Z-0067-2019",
      "event_date_initiated": "2018-08-28",
      "event_date_created": "2018-10-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2019-04-05",
      "res_event_number": "80966",
      "product_code": "DSQ",
      "pma_numbers": [
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      "product_description": "Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers:  1403, 1407, and 1420\n\nProduct Usage:\nThe HeartWare  HVAD  System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.",
      "code_info": "Serial number range:  CON300175 - CON320540",
      "firm_fei_number": "3007042319",
      "recalling_firm": "Heartware, Inc.",
      "address_1": "14400 Nw 60th Ave",
      "city": "Miami Lakes",
      "state": "FL",
      "postal_code": "33014-2807",
      "additional_info_contact": "MCS Customer Service\n877-367-4823",
      "reason_for_recall": "Certain HVAD System Controller units may not meet the labeled standard for protection against water or fluid ingress, specifically they may have the potential to develop hairline cracks at the power ports of the controller housing.",
      "root_cause_description": "Device Design",
      "action": "Medtronic began notifying Clinicians in the US on 28-Aug-2018 mainly via 2-day courier, of the identified issues and provided patient management recommendations.  Outside the US, Medtronic began notifying Clinicians on 30-Aug-2018 via locally approved methods.",
      "product_quantity": "17,275 units",
      "distribution_pattern": "Worldwide Distribution",
      "openfda": {
        "device_name": "Ventricular (Assist) Bypass",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
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