{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "221053",
      "product_res_number": "Z-2698-2026",
      "event_date_initiated": "2026-05-27",
      "event_date_posted": "2026-07-08",
      "recall_status": "Open, Classified",
      "res_event_number": "99207",
      "product_code": "QFG",
      "k_numbers": [
        "K251032"
      ],
      "product_description": "MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896",
      "code_info": "UDI-DI/GTIN: A7630006392701, 00763000521554, 00763000639273, A7630006392301, 00199150035687, A7630007325603, A7630007325601, 00763000639235, A7630007325604, 00763000384289, 00763000521530, A7630007325401, 00763000521547, A7630006392601, A7630006392201, 00763000639228, 00199150035663, 00763000639266, A7630007325404, 00199150035694, 00763000442194, A7630007325403, 00763000521523.\n\n\nSoftware version 6.62",
      "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": "Janet Cho\n800-646-4633 Ext. 1",
      "reason_for_recall": "A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by Pump Error 23. Insulin delivery will stop which may lead to delayed therapy and an increased risk of hyperglycemia or diabetic ketoacidosis (DKA).",
      "root_cause_description": "Software design",
      "action": "On 5/27/2026, field safety notices were emailed to customers who were asked to do the following:\n\n1) Update insulin pump software to version 6.63. The update may take up to 3 hours to complete.\n2) Reply to this email to confirm that you have read and understood this notification and, where applicable, completed the required action.\n\nIf you have questions, contact the firm at 01923 205167",
      "product_quantity": "778",
      "distribution_pattern": "International distribution to the countries of Spain, Great Britain, Netherlands, Italy.",
      "openfda": {
        "k_number": [
          "K191679",
          "K230545",
          "K241078",
          "K252770",
          "K240309",
          "K253074",
          "K232380",
          "K253743",
          "K231485",
          "K234027",
          "K223213",
          "K233952",
          "K203768",
          "K213536",
          "K261672",
          "K231826",
          "K250930",
          "K251032",
          "K213134",
          "K233044",
          "K253976",
          "K203234",
          "K241178",
          "K201214",
          "DEN180058",
          "K250792",
          "K253470",
          "K223846"
        ],
        "registration_number": [
          "3010291427",
          "3032746481",
          "2030624",
          "3016245399",
          "2032098",
          "3005627859",
          "3014197758",
          "3007981285",
          "3014585508",
          "2246552",
          "2024024",
          "3013756811",
          "3016798778",
          "3044561902",
          "1220973",
          "3016540876",
          "3015192982",
          "3008824097",
          "2029275",
          "2030598",
          "3019004087",
          "3026266833",
          "3047799708",
          "1220477",
          "2022435",
          "3019807891",
          "2032227",
          "3042027705",
          "3030970576"
        ],
        "fei_number": [
          "3010291427",
          "3032746481",
          "1000306431",
          "3000206435",
          "3016245399",
          "3005627859",
          "3014197758",
          "3007981285",
          "3014585508",
          "2246552",
          "2024024",
          "3013756811",
          "3016798778",
          "3044561902",
          "1000518731",
          "1220973",
          "3003058448",
          "3016540876",
          "3015192982",
          "3008824097",
          "3019004087",
          "3026266833",
          "3047799708",
          "1220477",
          "2022435",
          "3019807891",
          "3042027705",
          "3003166194",
          "3030970576"
        ],
        "device_name": "Alternate Controller Enabled Insulin Infusion Pump",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "880.5730",
        "device_class": "2"
      }
    }
  ]
}