{
  "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": "2026-10-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "180090",
      "product_res_number": "Z-1498-2020",
      "event_date_initiated": "2020-02-24",
      "event_date_created": "2020-03-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2022-08-04",
      "res_event_number": "85098",
      "product_code": "DWC",
      "k_numbers": [
        "K052601"
      ],
      "product_description": "LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.",
      "code_info": "Device Listing: E572259  Product Code  Product Description          Affected Serial Number range 16-02-80          Heater-Cooler 3T, 230V   16S10027   16S16874 16-02-81          Heater-Cooler 3T, 240V   16S10743   16S11708 16-02-82          Heater-Cooler 3T, 208V   16S10772   16S16840 16-02-83          Heater-Cooler 3T, 127V   16S11455   16S16509 16-02-85          Heater-Cooler 3T, 120V   16S10958   16S16847 16-02-95          Heater-Cooler 3T, 200V   16S12004   16S16818",
      "firm_fei_number": "1718850",
      "recalling_firm": "LivaNova USA Inc.",
      "address_1": "14401 W 65th Way",
      "city": "Arvada",
      "state": "CO",
      "postal_code": "80004-3503",
      "additional_info_contact": "303-467-6306",
      "reason_for_recall": "The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.",
      "root_cause_description": "Device Design",
      "action": "On 02/24/2020, the firm sent an \"URGENT MEDICAL DEVICE CORRECTION\" Letter to customers informing them that the firm is executing a voluntary correction for their Heater-Cooler Systems and providing customers with a recently cleared operating instructions that includes a validated instructions for cleaning and disinfecting the external surfaces, connectors, fittings, and water circuits.  The firm is instructing customers to discard or destroy older versions of the operating instruction and advising that all Heater-Cooler Systems in use at their facility should be upgraded with the 3T Aerosol Collection Set (vacuum canister and internal seal) to further reduce the risk of potential aerosol emission form the 3T system.\n\nThese corrections apply to all 3T Systems currently in distribution, which includes upgrading any loaners that were previously distributed or that are pending distribution.\n\nActions to be Taken by the Customer/User\nUse the Validated Operating Instructions Provided with this Customer Letter\n\" The FDA cleared Operating Instructions are found in Attachment 1 as well as at Product Resources on www.livanova.com.\n- Please read and follow the instructions carefully.\n- Section 2.1.5 Integrating the HC3T into your facility provides guidance on the use of the 3T System in your facility, highlighting critical tasks that users had the most difficulty with during human factors testing.\n- Section 6 Maintaining the heater-cooler provides guidance on the maintenance of the 3T System including the validated cleaning and disinfection instructions.\n- Section 7.1.4 General performance data describes performance testing results that emphasize the importance of following the cleaning and disinfection instructions and consistently using the 3T Aerosol Collection Set during surgeries. Specifically, these results describe how (1) the disinfection and water maintenance process maintains water quality and (2) the 3T Aerosol Collection Set design change reduces the",
      "product_quantity": "Total Worldwide=9309 systems (2713 system in U.S.)",
      "distribution_pattern": "U.S. Nationwide distribution including Puerto Rico.\n\nThis matter was triggered by the clearance of K191402, thus only the United States, including Puerto Rico, is affected.\n\nO.U.S. - none",
      "openfda": {
        "k_number": [
          "K841402",
          "K883603",
          "K031544",
          "K896972",
          "K822874",
          "K873924",
          "K122813",
          "K130300",
          "K896393",
          "K014016",
          "K001520",
          "K896973",
          "K052601",
          "K874927",
          "K873699",
          "K896974",
          "K071521",
          "K945720",
          "K831677",
          "K873813",
          "K140012",
          "K220635",
          "K896971",
          "K003145",
          "K102147",
          "K896975",
          "K893940",
          "K810647",
          "K212657",
          "K191402"
        ],
        "registration_number": [
          "1720929",
          "3006073153",
          "3001588119",
          "1723241",
          "3007899424",
          "1928237",
          "1516825",
          "9611109",
          "1828100",
          "1649914"
        ],
        "fei_number": [
          "1000517719",
          "1720929",
          "3006073153",
          "3002808267",
          "3001588119",
          "3007899424",
          "1928237",
          "1516825",
          "1828100",
          "3001665800"
        ],
        "device_name": "Controller, Temperature, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4250",
        "device_class": "2"
      }
    }
  ]
}