{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "149075",
      "product_res_number": "Z-0006-2017",
      "event_date_initiated": "2016-08-17",
      "event_date_created": "2016-10-13",
      "recall_status": "Open, Classified",
      "res_event_number": "74999",
      "product_code": "DSQ",
      "pma_numbers": [
        "P100047"
      ],
      "product_description": "HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103;  and International Product:  Model No.: 1104XX.\n\n\nProduct Usage:  For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.",
      "code_info": "All sterile un-implanted stock manufactured prior to HW25838 is subject to removal.",
      "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": "Kate Jacobson\n305-364-1575",
      "reason_for_recall": "Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults.",
      "root_cause_description": "Component design/selection",
      "action": "HeartWare notified their customers with an Urgent Medical Device Recall notice on 8/17/2016 of the HVAD Pump, listing the US Product: Model No. 1103 and the International Product: Model No.: 1104.  The letter discussed the reason for the recall as well as the risk to health.  Customers were to identify affected product in their inventory; and, complete and return the acknowledgement form.   Acknowledgement should be provided no later than 30 days from date of the letter either to the HeartWare representative; or, via e-mail to FSCA @Heartware.com; or, FAX the signed form to (305) 364-2665.  Affected product should be returned upon receipt of replacement product; and, the completion form should also be completed and returned.  Questions or concerns should be directed to a local HeartWare representative.",
      "product_quantity": "344 pumps",
      "distribution_pattern": "Worldwide Distribution - US, in the states of AL, AR, AZ, CA, DC, FL, IL, IN, KY, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, and WI; and, the countries of Argentina, Belarus, Bosnia, Herzegovina, Brazil, Canada, Chile, Colombia, Hong Kong, India, Israel, Kazakhstan, Kuwait, Lebanon, Malaysia, New Zealand, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Taiwan, Turkey, and Vietnam.",
      "openfda": {
        "device_name": "Ventricular (Assist) Bypass",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
          "P170038",
          "P100047",
          "P980012",
          "P160035",
          "P900023",
          "P060040",
          "P160054",
          "P920014",
          "P870072"
        ],
        "registration_number": [
          "3007042319",
          "1927395",
          "9612515",
          "3008792657",
          "3019807891",
          "3010163695",
          "2029275",
          "3003306248",
          "2182208",
          "3012931014",
          "3011823740",
          "3004582654",
          "3005228872",
          "2916596",
          "1721676",
          "2133810",
          "1319639",
          "3002807090",
          "2134470",
          "2031044",
          "1218444",
          "2528981",
          "3008454189"
        ],
        "fei_number": [
          "3007042319",
          "1927395",
          "1000138054",
          "3000203066",
          "3008792657",
          "3001236763",
          "3019807891",
          "3010163695",
          "3002808437",
          "3003306248",
          "1000306431",
          "2182208",
          "3012931014",
          "3011823740",
          "3004582654",
          "3005228872",
          "2916596",
          "1721676",
          "3006003617",
          "1218444",
          "2528981",
          "3008454189",
          "3002462840"
        ]
      }
    }
  ]
}