{
  "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": {
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      "cfres_id": "203595",
      "product_res_number": "Z-0217-2024",
      "event_date_initiated": "2022-05-27",
      "event_date_posted": "2023-11-03",
      "recall_status": "Completed",
      "res_event_number": "93170",
      "product_code": "MHY",
      "pma_numbers": [
        "P960009"
      ],
      "product_description": "LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.",
      "code_info": "UDI/DI 00763000274320, Serial Number VA2JV2V",
      "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": "Medtronic Customer Service\n800-962-9888",
      "reason_for_recall": "There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD printed on the individual product label.",
      "root_cause_description": "Labeling Change Control",
      "action": "Medtronic issued a Medical Device Removal notice to its consignees on 05/27/2023 by US mail.  The notice explained the issue, potential risk, and requested the return of the affected product.",
      "product_quantity": "14 units",
      "distribution_pattern": "US:  MO, FL, TX, WA",
      "openfda": {
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        "device_name": "Stimulator, Electrical, Implanted, For Parkinsonian Tremor",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
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    }
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}