{
  "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": "189719",
      "product_res_number": "Z-0273-2022",
      "event_date_initiated": "2021-09-27",
      "event_date_created": "2021-11-19",
      "recall_status": "Open, Classified",
      "res_event_number": "88845",
      "product_code": "OCL",
      "k_numbers": [
        "K123733"
      ],
      "product_description": "Cardioblate CryoFlex Surgical Ablation Console",
      "code_info": "1) Model 65CS1:\nSerial 10047 (GTIN 00763000014988)\nSerial 10048 (GTIN 00763000014988)\nSerial 10050 (GTIN 00763000014988)\nSerial 1689 (GTIN 00643169183834)\nSerial CSC-591 (GTIN 00613994867315)\nSerial CSC055 (GTIN 00613994867315)\nSerial 10051 (GTIN 00763000014988)\n\n2) Model R65CS1:\nSerial RCSC-201 (GTIN 00613994981516)",
      "firm_fei_number": "1000116158",
      "recalling_firm": "Medtronic Perfusion Systems",
      "address_1": "7611 Northland Dr N",
      "city": "Brooklyn Park",
      "state": "MN",
      "postal_code": "55428-1088",
      "additional_info_contact": "763-391-9000",
      "reason_for_recall": "There is potential for intermittent electrical connectivity between the console and probe.",
      "root_cause_description": "Process control",
      "action": "In the United States (US), beginning 27-SEP-2021 Medtronic initiated communications of an Urgent Medical Device Correction letter via 2-day UPS delivery to consignees who have received affected product according to Medtronic records.\n\nOutside of the United States (OUS), beginning 27-SEP-2021, a written Urgent Medical Device Correction letter is being delivered via regionally approved methods to consignees who have received affected product according to Medtronic records. \n\nConsignees are asked to review the Medtronic Urgent Medical Device Correction notification and follow the Recommended Actions, including quarantining affected Cardioblate CryoFlex Surgical Ablation Consoles in their inventory for servicing.",
      "product_quantity": "7 devices",
      "distribution_pattern": "Distribution in US - IL, KS, and UT\n\nDistribution outside of US to Australia and South Korea",
      "openfda": {
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          "K190587",
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          "K062140",
          "K193162",
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          "K043579",
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          "K183065",
          "K101174",
          "K050459",
          "K100501",
          "K130521",
          "K011040",
          "K234151"
        ],
        "device_name": "Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4400",
        "device_class": "2",
        "registration_number": [
          "3026612481",
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}