{
  "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": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "199300",
      "product_res_number": "Z-1408-2023",
      "event_date_initiated": "2023-03-17",
      "event_date_posted": "2023-04-19",
      "recall_status": "Open, Classified",
      "res_event_number": "91957",
      "product_code": "MHY",
      "pma_numbers": [
        "P960009S391"
      ],
      "product_description": "Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and passage of extensions for deep brain stimulation",
      "code_info": "UDI/DI00763000426361, Serial Numbers:  HG56BR6, HG56C4R, HG56CJAH01, HG56CLE, HG586N7, HG586UM, HG58704, HG58VM0, HG58VQH, HG58VQHH01, HG58VY5, HG58W7H, HG58WWC, HG58WYB, HG58WYBH01, HG58X0E, HG597BH, HG597DH, HG597M8, HG59ABH, HG59AFC, HG59AV6, HG59RY0, HG5A9GT, HG5A9VY, HG5A9VZ, HG5AQH0, HG5AQQE, HG5BQ5Y, HG5BQLR, HG5BQPJ, HG5BTW7, HG5BTZX, HG5BU5W, HG5BU77, HG5EPSB, HG5EQ0C, HG5EQ2A, HG5EQ69, HG5F31N, HG5F338, HG5F3AZ, HG5F3EH, HG5F3G6, HG5F3K5, HG5F3NF, HG5FP0Y, HG5FP3B, HG5FP70, HG5FP70H01, HG5FPBE, HG5HQBM, HG5HQF8, HG5LJTL, HG5LJZQ, HG5LK2J, HG5LK4H, HG5LK5Y, HG5LK7C, HG5LK8P, HG5LK92, HG5LKAL, HG5LKC9, HG5LKEL, HG5LKGT, HG5LR02, HG5LR33, HG5LTWA, HG5LTWP, HG5LTXU, HG5LTYY, HG5LU12; \nUDI/DI 00763000486518, Serial Numbers:  HG59ABH, HG59RY0, HG59SJ4, HG59SNC, HG5A9H3, HG5A9NB, HG5A9VY, HG5BQ5Y, HG5BQAW, HG5BQLR.",
      "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\n763-526-9452",
      "reason_for_recall": "Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers with have been machined on only one side.  As a result, the dual carrier cannot be used to pass two extensions simultaneously.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Medtronic issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 03/17/2023 via UPS 2-day delivery.  The notice explained the issue and the hazard and requested the following actions be taken:  \nQuarantine all unused product from the affected lots and return them as described on the Customer Confirmation Form.  Pass the notice to all those who need to be aware within your organization or to any organization where the potentially affected product has been transferred or distributed.",
      "product_quantity": "1414 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Luxembourg, Netherlands, New Zealand, Portugal, Slovakia, Spain, Sweden, Switzerland, United Kingdom.",
      "openfda": {
        "pma_number": [
          "P960009",
          "P140009"
        ],
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        ],
        "device_name": "Stimulator, Electrical, Implanted, For Parkinsonian Tremor",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}