{
  "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": 1
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  "results": [
    {
      "cfres_id": "186391",
      "product_res_number": "Z-1438-2021",
      "event_date_initiated": "2021-02-26",
      "event_date_created": "2021-04-20",
      "recall_status": "Open, Classified",
      "res_event_number": "87604",
      "product_code": "DSQ",
      "pma_numbers": [
        "P100047"
      ],
      "product_description": "Instructions for Use and Patient Manual for HeartWare HVAD System.\nAccompanies these devices:\nHeartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU.  \n\nHeartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, and 1420JP.  \n\nHeartware HVAD controller AC adapter  Models 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, and 1430US.  \n\nHeartware HVAD controller DC Adapter Model 1440.  \n\nHeartware HVAD data cable - monitor Model 1575.  \n\nHeartware HVAD battery pack Models 1650, 1650CA-CLIN, and 1650DE.  \n\nHeartware HVAD patient pack Model 1475.  \n\nHeartware HVAD waist pack Models 2050, 2050IL, and 2050US.  \n\nHeartware HVAD shoulder pack Models 2060, 2060IL, and 2060US.",
      "code_info": "Model, GTIN:   1100,  No GTIN Available;  1101,  No GTIN Available;  1102,  No GTIN Available;  1103,  00888707000017;  1104,  No GTIN Available;  1104JP,  00888707000697;  1205,  No GTIN Available;  MCS1705PU,  00888707005364;  1403US,  00888707000475;  1407AU,  00888707001663;  1407CA,  00888707002851;  1407CH,  00888707001694;  1407DE,  00888707001700;  1407GB,  00888707001717;  1407IL,  00888707001724;  1407IN,  00888707001731;  1407IT,  00888707001748;  1407JP,  00888707001755;  1407KR,  00888707001762;  1420,  00888707000420;  1420JP,  00888707000437;  1430AR,  00888707000826;  1430AU,  00888707000833;  1430CA,  00888707000857;  1430CH,  00888707000871;  1430DE,  00888707000864;  1430GB,  00888707000888;  1430IL,  00888707000901;  1430IN,  00888707000505;  1430IT,  00888707000895;  1430JP,  00888707000918;  1430US,  00888707000307;  1440,  00888707001885;  1575,  00888707008051;  1650,  00888707000376;  1650CA-CLIN,  00888707001588;  1650DE,  00888707001373;  1475,  00888707008037;  2050,  00888707008082;  2050IL,  00888707001410;  2050US,  00888707000048;  2060,  00888707008099;  2060IL,  00888707001427;  2060US,  00888707000055;",
      "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": "IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling is being corrected to reflect the actual verified behavior of a successful connector to the controller, which is a \"beep\" and not \"audible click\", to clarify under what alarm conditions a beep will not be heard, and identify alternate confirmation methods (visual indicator) for successful connection.  NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87603",
      "root_cause_description": "Device Design",
      "action": "Beginning 26-Feb-2021, an Urgent Medical Device Recall notification was disseminated to consignees who Medtronic records indicate have received affected product, UPS 2-day delivery. The notices provided updated information for the instructions for use and patient manual.",
      "product_quantity": "23123 (11292 US)",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of Italy, Great Britain, Germany, Japan.",
      "openfda": {
        "device_name": "Ventricular (Assist) Bypass",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
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          "P980012",
          "P160054",
          "P160035",
          "P900023",
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          "P170038",
          "P060040",
          "P870072"
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