{
  "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-2520-2026",
      "product_description": "Brand Name: HeartMate  Product Name: HM 11V Li-ion Backup Battery, ABT  Model/Catalog Number: 106128  Software Version: N/A  Product Description: The HeartMate 11 Volt Lithium Ion Standalone Backup Battery is a component of the HeartMate 3\" System Controller and provides power to the System Controller. The HeartMate System Controller is an external device that manages the HeartMate Left Ventricular Assist System (LVAS), including alarms, system monitoring, and communication. It contains an internal 11V lithium-ion backup battery that provides at least 15 minutes of emergency power should the main system power source fail. The backup battery must be properly installed, charges automatically during normal use, and has a 36-month service life from date of manufacture.  Component: Yes, HeartMate 3\" System Controller",
      "product_quantity": "12",
      "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: 106128 UDI/GTIN 05415067039880 Serial Numbers Distributed in US: See Attachment E for serial numbers distributed.",
      "more_code_info": ""
    }
  ]
}