{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "64346",
      "product_res_number": "Z-0040-2008",
      "event_date_initiated": "2007-06-25",
      "event_date_posted": "2007-10-12",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-10-08",
      "res_event_number": "44740",
      "product_code": "EZW",
      "pma_numbers": [
        "P970004"
      ],
      "product_description": "Medtronic InterStim INS (Model 3023) with N'Vision Inter Stim-B software supplied on the Model 8870 Version MMB_01/NNB_01 with N'Vision Clinician Programmer Model 8840 or InterStim iCon Patient Programmer Model 3037. Implantable Neurostimulator for Urinary Control.",
      "code_info": "All serial numbers within these catalog/model numbers are affected (Model 3023, Catalog Number 8870MMB01 and 8870NNB01)",
      "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",
      "additional_info_contact": "763-514-5174",
      "reason_for_recall": "Software issue may cause false low battery alert to be displayed when interrogating an Interstim Implantable Neurostimulator (Model 3023) with an N'Vision Clinician Programmer (Model 8840), or with an Inter Stim iCon Patient Programmer (Model 3037).",
      "root_cause_description": "Software design",
      "action": "Begining on July 11, 2007 a letter to the physicians was sent informing them of the issue and patient management for the two issues.  The letter includes a Cover Letter, A Reply Form, and two Recall letters explaining the issue in detail.",
      "product_quantity": "1885",
      "distribution_pattern": "Nationwide and the Netherlands.",
      "openfda": {
        "pma_number": [
          "P970004",
          "P240031",
          "P180046",
          "P170001"
        ],
        "registration_number": [
          "3010291427",
          "3003120897",
          "3002968685",
          "3018094310",
          "2011171",
          "2135338",
          "3015151147",
          "2124215",
          "3005210579",
          "3009380063",
          "3010972758",
          "3021836309",
          "3003477135",
          "2182207",
          "1319639",
          "2183744",
          "3014845032",
          "2649622",
          "3019807891",
          "3004593495",
          "3009183442",
          "3004209178"
        ],
        "fei_number": [
          "3010291427",
          "3003120897",
          "1000138054",
          "3018094310",
          "3002968685",
          "2011171",
          "3015151147",
          "2124215",
          "3005210579",
          "3005700659",
          "3009380063",
          "3010972758",
          "3021836309",
          "3003477135",
          "3004369318",
          "2182207",
          "2183744",
          "3014845032",
          "2649622",
          "3019807891",
          "3004593495",
          "3009183442"
        ],
        "device_name": "Stimulator, Electrical, Implantable, For Incontinence",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5270",
        "device_class": "3"
      }
    }
  ]
}