{
  "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": "2026-09-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "136083",
      "product_res_number": "Z-1604-2015",
      "event_date_initiated": "2015-04-29",
      "event_date_posted": "2015-05-14",
      "recall_status": "Open, Classified",
      "res_event_number": "71099",
      "product_code": "DSQ",
      "pma_numbers": [
        "P100047"
      ],
      "product_description": "HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit\n\nProduct Usage:\nIs intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).",
      "code_info": "Catalog #: ASY00116: HVAD Pump Driveline Splice Kit Lot #'s 532770, 567949, 480786, 483769, 490692, 539664, and  598189  and Catalog #: ASY00281: HVAD Pump Driveline Splicekit; Large OD Sheath Lot #'s 654090, 672401, 678800, 690423, 833963, 873159, and 880816",
      "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": "Clinical Support\n305-364-1575",
      "reason_for_recall": "Failures of the splice repair kit if exposed to excessive force.",
      "root_cause_description": "Device Design",
      "action": "HeartWare, Inc. sent an Urgent Medical Device Correction letter to all affected consignees on May 11, 2015.  The letter identified the affected product, problem, and actions to be taken by the consignees. The firm requested that consignees: 1) review the notice and the Patient Communication contents, 2) forward the notice to individuals within their organization who need to be aware of the notice, 3) identify patients that are currently on support and have undergone a driveline splice repair, 4) distribute the Patient Communication to the affected patients in person, 5) continue to reinforce the messages described in the notice with patients who have experienced a splice repair during their regularly scheduled appointments, 6) complete, sign, and return the  \"Acknowledge and Completion Form to HeartWare within 30 days of receipt of the letter.  Should any questions or concerns arise, please contact there local HeartWare representative.  Their 24-hour Clinical Support personnel are also available at 1 (888) 494-6365.",
      "product_quantity": "35",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of FL, KY, MO, NY, TN,TX, and the countries of: Canada, Germany, Italy, Netherlands, Turkey and United Kingdom.",
      "openfda": {
        "device_name": "Ventricular (Assist) Bypass",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
          "P100047",
          "P170038",
          "P060040",
          "P160054",
          "P900023",
          "P920014",
          "P980012",
          "P160035",
          "P870072"
        ],
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