{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "46457",
      "product_res_number": "Z-0022-2007",
      "event_date_initiated": "2006-06-06",
      "event_date_posted": "2006-10-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-07-06",
      "res_event_number": "35595",
      "product_code": "LKK",
      "pma_numbers": [
        "P860004S042"
      ],
      "product_description": "Medtronic SynchroMed EL Programmable Pumps, Models 8627-10, 8627-18, 8627L-10, 8627L-18.  The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site.  The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.",
      "code_info": "Model 8627-10, serial numbers:  NGE000001 - NGE000242R .   Model 8627-18, serial numbers:  NGF000001 - NGF003266R.    Model 8627L-10, serial numbers:  NGG000001R - NGG000068R,    Model 8627L-18, serial numbers:  NGH000001R - NGH001780R.",
      "firm_fei_number": "2182207",
      "recalling_firm": "Medtronic Neuromodulation",
      "address_1": "800 53rd Ave NE",
      "address_2": "PO Box 1250",
      "city": "Minneapolis",
      "state": "MN",
      "postal_code": "55440-1250",
      "reason_for_recall": "The Catheter Access Port (CAP) on SynchroMed EL pumps manufactured between March and July 1999 may detach from the main body of the pump, which can interrupt drug flow to the target site.",
      "root_cause_description": "Process design",
      "action": "An Urgent medical Device Recall letter was sent to healthcare providers beginning June 06, 2006.  The letter describes the issue, patient risk, identifies affected devices, and provides patient Management recommendations. The letter also asks for a response card to be returned to Medtronic.  Patients may contact Medtronic Neurological Patient Services at 1-800-510-6735.",
      "product_quantity": "4,317 pumps",
      "distribution_pattern": "Worldwide distribution ---- including USA, Argentina, Barbados, Canada, Germany, India, Ireland, Italy, Mexico, The Netherlands, Spain, Switzerland, and United Kingdom.",
      "openfda": {
        "pma_number": [
          "P140032",
          "P800036",
          "P890055",
          "P860004",
          "P080012",
          "P990034"
        ],
        "registration_number": [
          "3004593495",
          "1422634",
          "3015537318",
          "3018094310",
          "3003120897",
          "3030198397",
          "3007829657",
          "1526611",
          "1722746",
          "2183319",
          "2032227",
          "3004209178",
          "3003174284",
          "2182207",
          "2124215",
          "2135338",
          "2523676",
          "2246552",
          "3009183442"
        ],
        "fei_number": [
          "3004593495",
          "3003166194",
          "3004369318",
          "1000306216",
          "3015537318",
          "3018094310",
          "1000514656",
          "3003120897",
          "3030198397",
          "3007829657",
          "1526611",
          "2183319",
          "3003174284",
          "2182207",
          "3005700659",
          "2124215",
          "2523676",
          "2246552",
          "3009183442"
        ],
        "device_name": "Pump, Infusion, Implanted, Programmable",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}