{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "176695",
      "product_res_number": "Z-0221-2020",
      "event_date_initiated": "2019-08-22",
      "event_date_posted": "2019-10-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-04-26",
      "res_event_number": "83895",
      "product_code": "KFM",
      "k_numbers": [
        "K020271"
      ],
      "product_description": "CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.",
      "code_info": "U.S. Model 102956 UDI: 07640135140078.  Motor serial numbers between L05333-0001 and L06608-0024",
      "firm_fei_number": "3003306248",
      "recalling_firm": "Thoratec Switzerland GMBH",
      "address_1": "Technoparkstrasse 1 1 technoparkstrasse",
      "city": "Zurich",
      "country": "Switzerland",
      "additional_info_contact": "Mr. Justin Paquette\n41444451913",
      "reason_for_recall": "Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).",
      "root_cause_description": "Process change control",
      "action": "A recall letter dated August 22, 2019 was issued on Abbott letterhead and was delivered by field representative visits beginning August 22, 2019 for the U.S. consignees.  Foreign consignees were notified with a letter dated August 22, 2019 containing the same content but OUS model numbers and OUS contact information.  Depending on the requirements by the local regulator, the letters may have been delivered by a field representative or via certified mail.  The letter identified the affected product, problem and actions to be taken.",
      "product_quantity": "664 units (381 U.S. and 283 OUS)",
      "distribution_pattern": "Distribution was nationwide.  There was government distribution, but no military distribution.  \n\nForeign distribution was made to Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Finland, France, Hong Kong, India, Israel, Italy, Liechtenstein, Mexico, Netherlands, Portugal, Qatar, Romania, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.",
      "openfda": {
        "k_number": [
          "K032040",
          "K063723",
          "K020529",
          "K033270",
          "K111972",
          "K132712",
          "K103357",
          "K031300",
          "K780953",
          "K232132",
          "K030154",
          "K023132",
          "K100631",
          "K962981",
          "K020998",
          "K051209",
          "K903925",
          "K852698",
          "K250326",
          "K011835",
          "K882758",
          "K110845",
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          "K012209",
          "K080774",
          "K884659",
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          "K972740",
          "K251762",
          "K851855",
          "K192850",
          "K900601",
          "K913176",
          "K012325",
          "K183623",
          "K842007",
          "K894255",
          "K933014",
          "K220842",
          "K110493",
          "K080470",
          "K111384",
          "K111657",
          "K190650",
          "K061072",
          "K202169",
          "K852807",
          "K020271",
          "K912604",
          "K030462",
          "K973011",
          "K133265",
          "K082321",
          "K952879",
          "K882129",
          "K073631",
          "K991783",
          "K915363",
          "K851613",
          "K991864",
          "K983272",
          "K050890",
          "K915547",
          "K112229",
          "K111658",
          "K992592",
          "K201068",
          "K201320",
          "K090515",
          "K921550",
          "K902198",
          "K233091",
          "K093801",
          "K013393",
          "K191077",
          "K050109",
          "K854975",
          "K083794",
          "K193663",
          "K770937",
          "K943861",
          "K083111"
        ],
        "registration_number": [
          "3044156918",
          "9681834",
          "3019807891",
          "1422634",
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          "3003661577",
          "3007427881",
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          "9617601",
          "2916596",
          "3006073153",
          "2011171",
          "1218444",
          "3008792657",
          "2029275",
          "1220648",
          "3005941719",
          "2184009",
          "1123137",
          "3006849754"
        ],
        "fei_number": [
          "3044156918",
          "3019807891",
          "3002534070",
          "3014990448",
          "3003661577",
          "3007427881",
          "3009649876",
          "3016746283",
          "3030125051",
          "2528981",
          "1000514656",
          "3003306248",
          "3000204839",
          "1000116158",
          "3009380063",
          "3010163695",
          "1928237",
          "3009507273",
          "3012119238",
          "3006003617",
          "1828100",
          "2828",
          "3011554160",
          "1000138054",
          "2916596",
          "3006073153",
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          "3008792657",
          "1000306431",
          "1220648",
          "3002808327",
          "3005426550",
          "1000123180",
          "3006849754"
        ],
        "device_name": "Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4360",
        "device_class": "2"
      }
    }
  ]
}