{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Minneapolis",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "70271",
      "recalling_firm": "Medtronic Neuromodulation",
      "address_1": "7000 Central Ave Ne",
      "address_2": "N/A",
      "postal_code": "55432-3568",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distributon- USA( nationwide including DC and PR) and Internationally to Mexico and Canada",
      "recall_number": "Z-1147-2015",
      "product_description": "The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, Peripheral Nervous System, or muscles when connected to an extension and/or lead.    The Medtronic InterStim II Neurostimulator, Model 3058, and Medtronic InterStim Neurostimulator, Model 3023, are parts of neurostimulation systems for InterStim Therapy.  The neurostimulators are multiprogrammable devices that accommodates a lead through which a stimulation program is delivered.    The Medtronic Enterra Neurostimulator, Model 3116, is part of an Enterra Therapy system for gastric electrical stimulation (GES).  The neurostimulator is a multiprogrammable device that accommodates a lead through which a stimulation program is delivered.",
      "product_quantity": "396,975 (258,805 USA, 138,170 OUS)",
      "reason_for_recall": "Current labeling indicates that cycling improves device longevity in every programming scenario. However, enabling cycling at certain parameter settings may decrease the device battery longevity. With cycling enabled, longevity estimate displayed on the Model 8840Programmer may be inaccurate.",
      "recall_initiation_date": "20150109",
      "center_classification_date": "20150224",
      "termination_date": "20170928",
      "report_date": "20150304",
      "code_info": "All lot/serial numbers are affected for all 4 Model numbers:    \" Model 7425   \" Model 3058   \" Model 3023   \" Model 3116",
      "more_code_info": ""
    }
  ]
}