{
  "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": "2026-06-24",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Pleasanton",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99023",
      "recalling_firm": "Thoratec LLC",
      "address_1": "6035 Stoneridge Dr",
      "address_2": "",
      "postal_code": "94588-3270",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Canada, Germany, Japan, Netherlands, Poland, Spain.",
      "recall_number": "Z-2518-2026",
      "product_description": "Brand Name: HeartMate  Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits  Model/Catalog Number: 106524US  Software Version: N/A  Product Description: The HeartMate 3\" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide therapeutic benefit to those affected with advanced heart failure. In service, the LVAS assumes some or all of the workload of the left ventricle, thereby restoring the patient's systemic perfusion while palliating the underlying pathology. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus all of the features, controls, attachments, interfaces, power sources, supporting equipment, labeling, and tools required to achieve the desired therapeutic benefit.  Component: No",
      "product_quantity": "4",
      "reason_for_recall": "Due to 11 volt Backup Battery failures.",
      "recall_initiation_date": "20260513",
      "center_classification_date": "20260618",
      "report_date": "20260624",
      "code_info": "Lot Code: Model Number: 106524US UDI/GTIN 05415067039323 Serial Numbers Distributed in US: See Attachment E for serial numbers distributed.",
      "more_code_info": ""
    }
  ]
}