{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
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  "results": [
    {
      "cfres_id": "187964",
      "product_res_number": "Z-2072-2021",
      "event_date_initiated": "2021-05-28",
      "event_date_created": "2021-07-13",
      "recall_status": "Open, Classified",
      "res_event_number": "88135",
      "product_code": "DSQ",
      "pma_numbers": [
        "P100047"
      ],
      "product_description": "HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: 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": "UDI: 00888707007139. Serial Number HW42843",
      "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": "The pump has an impeller with a shroud height that did not meet the lower control limit.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "The firm initiated the recall to the sole consignee on 05/28/2021 by telephone.  The consignee was asked to quarantine and return the affected device.",
      "product_quantity": "1 unit",
      "distribution_pattern": "International distribution to the country of Germany.",
      "openfda": {
        "pma_number": [
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        "device_name": "Ventricular (Assist) Bypass",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}