{
  "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
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  },
  "results": [
    {
      "cfres_id": "35401",
      "product_res_number": "Z-0046-05",
      "event_date_initiated": "2004-09-27",
      "event_date_posted": "2004-10-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-07-13",
      "res_event_number": "30209",
      "product_code": "MCM",
      "pma_numbers": [
        "P960058S030"
      ],
      "product_description": "Advanced Bionics implantable cochlear stimulator HiRes 90, \n\nModels\n CI-1400-01\nCI-1400-02",
      "code_info": "HiRes 90K Implantable Cochlear Stimulator, Model Number CI-1400-01, manufactured prior to December 1, 2003.",
      "firm_fei_number": "1000220815",
      "recalling_firm": "Advanced Bionics",
      "address_1": "12750 San Fernando Rd",
      "city": "Sylmar",
      "state": "CA",
      "postal_code": "91342-3728",
      "additional_info_contact": "Jeffrey H. Greiner\n877-454 Ext. 5038",
      "reason_for_recall": "All unimplanted CLARION and HiResolution cochlear implants due to the potential presence of moisture in the internal circuitry, which can cause the device to stop functioning.",
      "root_cause_description": "Other",
      "action": "Expanded recall was initiated with notification to clinicians on 9/27/2004. Expanded effort includes: notice to patients implanted, notice to clinicians, worldwide return of all unimplanted coclear implants.",
      "product_quantity": "46 units",
      "distribution_pattern": "U.S. and Canada and France",
      "openfda": {
        "device_name": "Implant, Cochlear",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
          "P940022",
          "P830069",
          "P000015",
          "P890027",
          "P840024",
          "P200021",
          "P000025",
          "P960058",
          "P970051"
        ],
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}