{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Pleasanton",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "82458",
      "recalling_firm": "Thoratec Corp.",
      "address_1": "6035 Stoneridge Dr",
      "address_2": "N/A",
      "postal_code": "94588-3270",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Visit",
      "distribution_pattern": "US Nationwide distribution in the states of MN, WI, TX, NC, GA, OK, UT, NY, SC, IL, LA, MI, IN, CA, OH, WA.    Foreign (OUS): AUSTRIA, BELGIUM, CANADA, ESTONIA, FRANCE, GERMANY, GREECE, INDIA, ITALY, KUWAIT, LIECHTENSTEIN, LITHUANIA, NETHERLANDS, POLAND, SAUDI ARABIA, SINGAPORE, SPAIN, SWITZERLAND, TURKEY, UNITED KINGDOM",
      "recall_number": "Z-1203-2019",
      "product_description": "Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only,  REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The Coring Tool provides a means to resect a plug of myocardium from the left ventricle, which allows for HeartMate 3 inflow cannula insertion.",
      "product_quantity": "650",
      "reason_for_recall": "Small black plastic particle was observed in the left ventricle during implant procedure.",
      "recall_initiation_date": "20190301",
      "center_classification_date": "20190419",
      "termination_date": "20220810",
      "report_date": "20190501",
      "code_info": "Lot Numbers:  6675594   6675724   6675730   6677921   6696569   6696580   6696582   6696597   6696601   6696604   6703553   6703561   6703563   6703567   6721603   6721660   6721661   6721663   6721671   6721672   6721673   193496   193497   193499   193501   6425740   6425773   6449684   6675597   6449680   6425751   6425758   6425763   6425768   6449657   6449662   6512124   6677922   6425756   6425766   6425770   6449675   6449681   6449691   6675592   6677919   6677926   6694918   6696574   193500   193502   6425745   6425776   6449663   6449664   6449679   6449682   6449687   6449689   6677924   6677927   6692906   6693957   6696589   193495   193498   6449692   6675591   6675596   6692904   6696599   6512126   6675732   6675734   6675736   6692897   6449677   6692877"
    }
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}