{
  "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": "210373",
      "product_res_number": "Z-0206-2025",
      "event_date_initiated": "2024-09-24",
      "event_date_posted": "2024-10-23",
      "recall_status": "Open, Classified",
      "res_event_number": "95489",
      "product_code": "MHY",
      "pma_numbers": [
        "P960009"
      ],
      "product_description": "Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.",
      "code_info": "GTIN 00763000813468, Serial Numbers:  NND504236H, NND504252H; \nGTIN 00763000813475, Serial Numbers:  NND504165H, NND504169H, NND504174H, NND504181H, NND504208H, NND504212H, NND504215H, NND504216H, NND504217H, NND504218H, NND504221H, NND504222H, NND504223H, NND504224H, NND504229H, NND504230H, NND504232H, NND504234H, NND504235H, NND504243H, NND504255H, NND504156H, NND504157H, NND504159H, NND504160H; \nGTIN 00763000813529, Serial Numbers: NND504167H, NND504178H, NND504179H, NND504180H, NND504182H, NND504227H, NND504228H;  \nGTIN A7630008135201, Serial Numbers:  NND504167H, NND504178H, NND504180H; \nGTIN A7630008134701, Serial Numbers:  NND504181H, NND504243H",
      "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": "Naomi Rodiles\n763-427-5521",
      "reason_for_recall": "A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an \"Invalid Device\" message will appear.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Medtronic neuromodulation issued an URGENT MEDICAL DEVICE RECALL notice to its consignees of 09/24/2024 via letter.  The notice explained the issue, potential risk, and requested the affected devices in stock be returned.  The notice is to be shared with those to whom the device was distributed.      \nIf the device has been implanted, the consignee was directed to contact their Medtronic Representative to determine if there are additional steps that may establish communication with the INS.  On 07-Oct-24 and 08-Oct-24, a Medtronic representative successfully performed an update using a manufacturing software tool to reestablish communication to the affected devices. Consignees were provided a consignee notification regarding this action.",
      "product_quantity": "39 units",
      "distribution_pattern": "International distribution to the countries of Germany, UK, and Israel.",
      "openfda": {
        "pma_number": [
          "P140009",
          "P960009"
        ],
        "registration_number": [
          "3004593495",
          "3019807891",
          "3010052483",
          "2024311",
          "3018094310",
          "2649622",
          "2183744",
          "3003120897",
          "3010086866",
          "3006630150",
          "2648729",
          "3003477135",
          "1627487",
          "3009380063",
          "1928237",
          "3013023969",
          "2133641",
          "3015924373",
          "3004209178",
          "3038429246",
          "2182207",
          "3003335547",
          "3006705815",
          "3005210579",
          "9616693",
          "2124215",
          "2135338",
          "3015200795",
          "3010972758",
          "2133772",
          "3010531069",
          "3005160949"
        ],
        "fei_number": [
          "3004593495",
          "3019807891",
          "3010052483",
          "3004369318",
          "2024311",
          "3018094310",
          "2649622",
          "2183744",
          "3003120897",
          "3010086866",
          "3006630150",
          "2648729",
          "3003477135",
          "1627487",
          "3009380063",
          "1928237",
          "3013023969",
          "3000203466",
          "3015924373",
          "3038429246",
          "2182207",
          "3003335547",
          "3006705815",
          "3005210579",
          "3005700659",
          "3002618605",
          "2124215",
          "3000209794",
          "3015200795",
          "3010972758",
          "3010531069",
          "3005160949"
        ],
        "device_name": "Stimulator, Electrical, Implanted, For Parkinsonian Tremor",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}