{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Minneapolis",
      "state": "MN",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63712",
      "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 distribution: USA (nationwide) and countries including: Canada and Mexico.",
      "recall_number": "Z-0496-2013",
      "product_description": "SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18.  implantable infusion pump.  The pump is part of an implanted infusion system that consists of a SynchroMed EL pump and a catheter.  The SynchroMed EL Infusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The SynchroMed EL Infusion System with a 10 mL reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids referred to in this manual.",
      "product_quantity": "174,700 devices total",
      "reason_for_recall": "Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance of the SynchroMed infusion pump system.  Use of unapproved drugs with SynchroMed pumps can result in an increased risk of permanent motor stall and cessation of drug infusion.       UPDATE 2/1/2016:  Medtronic received approval to incorporate enhancements to the SynchroMed II pump which decreases the potential for internal electrical shorting and motor corrosion, and is retrieving any unused pumps.",
      "recall_initiation_date": "20121109",
      "center_classification_date": "20121213",
      "termination_date": "20171231",
      "report_date": "20121219",
      "code_info": "All SynchroMed EL and SynchroMed II pumps"
    }
  ]
}