{
  "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": "191249",
      "product_res_number": "Z-0787-2022",
      "event_date_initiated": "2021-12-17",
      "event_date_created": "2022-03-15",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-01-08",
      "res_event_number": "89312",
      "product_code": "DWA",
      "k_numbers": [
        "K112225"
      ],
      "product_description": "Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device.",
      "code_info": "CP5 Drive Unit Serial Numbers:\n60E03336\n60E03339\n60E03344\n60E03347",
      "firm_fei_number": "3002808267",
      "recalling_firm": "LivaNova Deutschland GmbH",
      "address_1": "Lindberghstr. 25 25 lindberghstr.",
      "city": "Munich",
      "country": "Germany",
      "additional_info_contact": "082 323 010",
      "reason_for_recall": "One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.",
      "root_cause_description": "Process control",
      "action": "On 12/17/2021, the firm notified affected customers via email using a letter titled, \"URGENT MEDICAL DEVICE CORRECTION FA-CP-MUN-2021-001.\" The letter indicated the following actions to be taken by the customer: \n\nUsing the attached Customer Response Form (Attachment 1), please respond by email to LivaNova.FSCA@livanova.com to confirm the receipt of this letter and that you have read and understood its content.\n\nNo further action is requested. A LivaNova authorized technician will contact you to schedule an appointment and correct the devices with the missing ferrite ring. Any affected device currently in use may continue to be used without limitation.\n\nFor questions regarding this Medical Device Correction, please contact a LivaNova sales rep or send an e-mail LivaNova Quality Assurance Team at LivaNova.FSCA@livanova.com.\n\nPlease, complete this response form and return it via e-mail to LivaNova.FSCA@livanova.com no later than December 31st, 2021.",
      "product_quantity": "4",
      "distribution_pattern": "US distribution in states of FL, TX, and NE",
      "openfda": {
        "k_number": [
          "K924206",
          "K070286",
          "K936091",
          "K131179",
          "K061369",
          "K901584",
          "K924205",
          "K081221",
          "K032213",
          "K042374",
          "K941921",
          "K192838",
          "K232788",
          "K080824",
          "K103468",
          "K221491",
          "K090004",
          "K853126",
          "K200306",
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          "K191557",
          "K102129",
          "K914754",
          "K842503",
          "K091008",
          "K950739",
          "K053630",
          "K780952",
          "K854133",
          "K926357",
          "K011838",
          "K230698",
          "K112225",
          "K083340",
          "K093832",
          "K051303",
          "K971421"
        ],
        "registration_number": [
          "3015431638",
          "2011171",
          "3008792657",
          "3019807891",
          "3021562887",
          "3014990448",
          "3010163695",
          "3012119238",
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          "1220648",
          "3004593495",
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          "3010009632",
          "9611109",
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        ],
        "fei_number": [
          "3015431638",
          "1000116158",
          "2011171",
          "3008792657",
          "3019807891",
          "3021562887",
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          "3002808267",
          "1220648",
          "3004593495",
          "1218444",
          "3010009632",
          "3044156918"
        ],
        "device_name": "Control, Pump Speed, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4380",
        "device_class": "2"
      }
    }
  ]
}