{
  "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": "203871",
      "product_res_number": "Z-0354-2024",
      "event_date_initiated": "2023-10-19",
      "event_date_posted": "2023-11-20",
      "recall_status": "Open, Classified",
      "res_event_number": "93303",
      "product_code": "LGW",
      "product_description": "Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators",
      "code_info": "UDI/DI 00763000642297, Serial Numbers:  NLD172060N, NLD142952N, NLD172064N, NLD142947N, NLD142942N, NLD172061N, NLD172062N, NLD172063N, NLD172066N;\n\nUDI/DI 00763000724436, Serial Numbers:  NLD160337N, NLD163006N, NLD142943N, NLD163007N, NLD142944N, NLD163008N, NLD160338N, NLD163009N, NLD160339N, NLD163010N, NLD160340N, NLD163011N",
      "firm_fei_number": "2182207",
      "recalling_firm": "Medtronic Neuromodulation",
      "address_1": "7000 Central Ave Ne",
      "city": "Minneapolis",
      "state": "MN",
      "postal_code": "55432-3568",
      "additional_info_contact": "Jeffrey Trauring\n612-616-9628",
      "reason_for_recall": "Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.",
      "root_cause_description": "Software Manufacturing/Software Deployment",
      "action": "Medtronic issued an URGENT:  MEDICAL DEVICE RECALL notice to its consignees via regionally approved method beginning 10/19/2023.  The notice explained the issue,  potential risk to the patient, and requested the return of the units.",
      "product_quantity": "26 units",
      "distribution_pattern": "International distribution to the countries of S. Korea and Turkey.",
      "openfda": {
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        "device_name": "Stimulator, Spinal-Cord, Totally Implanted For Pain Relief",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}