{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "222434",
      "product_res_number": "Z-0203-2027",
      "event_date_initiated": "2026-09-11",
      "event_date_posted": "2026-10-21",
      "recall_status": "Open, Classified",
      "res_event_number": "99765",
      "product_code": "PHV",
      "product_description": "CareLink Clinic, REF: MMT-7350",
      "code_info": "UDI-DI: 0763000B00008748K.\n\nSoftware Versions: 4.4A\n\nSoftware Available:\nUS: Between June 4th, 2026, and June 8th, 2026.",
      "firm_fei_number": "3003166194",
      "recalling_firm": "Medtronic MiniMed, Inc.",
      "address_1": "18000 Devonshire St",
      "city": "Northridge",
      "state": "CA",
      "postal_code": "91325-1219",
      "additional_info_contact": "Ashley Patterson\n800-646-4633",
      "reason_for_recall": "CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to use custom values entered by healthcare professionals (HCPs) for Total Daily Dose (TDD) or Long-acting insulin when calculating the Carb Ratio, Insulin Sensitivity Factor (ISF), and Max Recommended value for Rapid-acting insulin. Instead, the calculator continues to use the system-recommended values, resulting in incorrect rapid-acting insulin parameters. If an HCP or patient inputs these incorrect setting values into the patient's MiniMed Go app, the patient could deliver higher or lower insulin doses compared to their insulin needs, potentially leading to over/under delivery of insulin with a severity ranging from Catastrophic (death from severe hypoglycemia) to Minor (self-treatable hypoglycemia/hyperglycemia).",
      "root_cause_description": "Software design",
      "action": "On 9/11/2026, correction notices were mailed to the health care professional, and customer asking them to do the following:\n\nThe Customer was asked to do the following:\nImmediately contact your Healthcare Provider (HCP) to confirm your insulin settings values.\n\nComplete and return the confirmation form by visiting https://info.medtronicdiabetes.com/FA1587 \n\nThe health care professional was asked to do the following: If you provided diabetes treatment recommendations to patients based on custom Total Daily Dose(TDD) or long-acting insulin values entered into the CareLin Clinic Settings Calculator between: June 04, 2026, to June 08, 2026, please revisit those recommendations utilizing patients' individual CareLink reports.\n\nContinue to follow up with those patients pursuant to your standard of care.\n\nIf you have further questions or need assistance, please call the firm's 24-Hour Technical Support line at 1-800-646-4633, option 1.",
      "product_quantity": "1",
      "distribution_pattern": "US Nationwide distribution in the state of KS.",
      "openfda": {
        "k_number": [
          "DEN140016"
        ],
        "registration_number": [
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          "3007981285",
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        "fei_number": [
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          "3007981285",
          "3009137498",
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          "3014642500",
          "3021611414",
          "3003166194",
          "3002803444",
          "3013922904",
          "3012128418"
        ],
        "device_name": "Continuous Glucose Monitor Retrospective Data Analysis Software",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.2120",
        "device_class": "1"
      }
    }
  ]
}