{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 6
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  },
  "results": [
    {
      "cfres_id": "186039",
      "product_res_number": "Z-1336-2021",
      "event_date_initiated": "2021-02-26",
      "event_date_created": "2021-04-06",
      "recall_status": "Open, Classified",
      "res_event_number": "87446",
      "product_code": "DSQ",
      "pma_numbers": [
        "P100047"
      ],
      "product_description": "Medtronic HVAD Controller, Product Numbers:  1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 1401US, 1403US, 1407AR, 1407AU, 1407BR, 1407CA, 1407CA-CLIN, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR",
      "code_info": "All lot codes",
      "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": "There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the Controller ports, due to wear  from misalignment of the cables to the port.",
      "root_cause_description": "Device Design",
      "action": "The firm issued a Medical Device Notice to its consignees on 02/26/2021 by letter delivered via UPS 2-day delivery.  The letter explained the issue and directed the physician to review the patient management recommendations on the frequency of of inspecting the HVAD Controller, HVAD Controller power cables, and HVAD Monitor data cables.  For questions regarding this material, please contact your Medtronic Field Representative.",
      "product_quantity": "56,018 units (28,449 US)",
      "distribution_pattern": "Worldwide",
      "openfda": {
        "device_name": "Ventricular (Assist) Bypass",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
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          "P980012",
          "P160054",
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          "P870072"
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