{
  "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": 16
    }
  },
  "results": [
    {
      "cfres_id": "175194",
      "product_res_number": "Z-1581-2020",
      "event_date_initiated": "2019-06-27",
      "event_date_posted": "2020-03-26",
      "recall_status": "Open, Classified",
      "res_event_number": "83433",
      "product_code": "LZG",
      "k_numbers": [
        "K990801"
      ],
      "product_description": "MiniMed Insulin Pump, model # MMT-508",
      "code_info": "All Software Versions",
      "firm_fei_number": "3003166194",
      "recalling_firm": "Medtronic MiniMed",
      "address_1": "18000 Devonshire St",
      "city": "Northridge",
      "state": "CA",
      "postal_code": "91325-1219",
      "additional_info_contact": "Medtronic 24-hr Technical Support\n818-576-4700",
      "reason_for_recall": "The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.",
      "root_cause_description": "Device Design",
      "action": "On June 27, 2019, Medtronic issued an Urgent Field Safety Notification letter via mail and email to its consignees.  Medtronic made the decision to renotify customers, and on January 4, 2023, Medtronic issued an Urgent Medical Device Correction - Update letter. The communication asks consignees to take the following actions:\n\n.To find the software version for the MiniMed Paradigm pumps, go to the STATUS screen:\n. To open the STATUS screen, press ESC until the STATUS screen appears.  \n\n. To view more text on the STATUS screen, press the up or down arrow to scroll and view all the information.  \n\n. To exit the STATUS screen, press ESC until the STATUS screen disappears.  \n  ACTIONS REQUIRED: \n\n1. Review and take the following cybersecurity precautions listed below. \n\n2. Please complete and sign the customer confirmation form attached as indicated and return by mail using the attached prepaid envelope. You can also email this form to our Field Corrective Action Department at rs.safetyinformation@medtronic.com or send via fax to 1-888-844-8084 to the attention of FCA Department.",
      "product_quantity": "64,174 units",
      "distribution_pattern": "US nationwide distribution including Puerto Rico.",
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          "3003024060",
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        ],
        "device_name": "Pump, Infusion, Insulin",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5725",
        "device_class": "2"
      }
    }
  ]
}