{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "53499",
      "product_res_number": "Z-0037-2008",
      "event_date_initiated": "2007-06-25",
      "event_date_posted": "2007-10-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-10-08",
      "res_event_number": "38371",
      "product_code": "EZW",
      "pma_numbers": [
        "P970004"
      ],
      "product_description": "Medtronic InterStim II INS Model 3058 with N'Vision InterStim-B Software supplied on the Model 8870 Version MMB_01/NNB_01 N'Vision with a Clinic an Programmer Model 8840.  Implantable Neurostimulator for Urinary Control.",
      "code_info": "All serial numbers within these catalog/model numbers are affected: Model 3058, Catalog # 8870MM01 & 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": "A software issue may cause a lower than expected battery capacity estimate when evaluating an InterStim II Implantable Neurostimulator (model 3058) with an N'Vision Clinician Programmer(Model 8840) before implant .",
      "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 mangement of 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": [
          "P170001",
          "P240031",
          "P180046",
          "P970004"
        ],
        "registration_number": [
          "2011171",
          "3005210579",
          "3019807891",
          "3002968685",
          "3018094310",
          "3003120897",
          "3014845032",
          "2182207",
          "2124215",
          "2649622",
          "3009183442",
          "3003477135",
          "3004209178",
          "2183744",
          "1319639",
          "3010972758",
          "3021836309",
          "3004593495",
          "3010291427",
          "3009380063",
          "2135338",
          "3015151147"
        ],
        "fei_number": [
          "3005700659",
          "1000138054",
          "2011171",
          "3005210579",
          "3019807891",
          "3002968685",
          "3018094310",
          "3003120897",
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          "2649622",
          "3009183442",
          "3003477135",
          "2183744",
          "3004369318",
          "3010972758",
          "3021836309",
          "3004593495",
          "3010291427",
          "3009380063",
          "3015151147"
        ],
        "device_name": "Stimulator, Electrical, Implantable, For Incontinence",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5270",
        "device_class": "3"
      }
    }
  ]
}