{
  "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
    }
  },
  "results": [
    {
      "cfres_id": "210208",
      "product_res_number": "Z-0137-2025",
      "event_date_initiated": "2024-09-11",
      "event_date_posted": "2024-10-21",
      "recall_status": "Open, Classified",
      "res_event_number": "95419",
      "product_code": "LKK",
      "product_description": "SynchroMed II Infusion Pump. Product Number: 8637-20",
      "code_info": "GTIN Number: 00643169630505. Serial Number: NGP004814H",
      "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": "Jeff Trauring\n763-760-0001",
      "reason_for_recall": "Potential for error and inability to interrogate pump due to data corruption in the pump memory.",
      "root_cause_description": "Device Design",
      "action": "On 11-September-2024, a Medtronic representative was sent to the physician s facility where the representative provided the communication and confirmation form to the physician. The physician was asked to sign the confirmation form indicating they read the notification. The representative reset the patient s pump.",
      "product_quantity": "1 unit",
      "distribution_pattern": "US Nationwide distribution in the state of Mississippi.",
      "openfda": {
        "pma_number": [
          "P990034",
          "P080012",
          "P140032",
          "P860004",
          "P800036",
          "P890055"
        ],
        "registration_number": [
          "3003120897",
          "3015537318",
          "3030198397",
          "3018094310",
          "2523676",
          "2135338",
          "2124215",
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          "1526611",
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          "3004209178"
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        "fei_number": [
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          "3015537318",
          "3003166194",
          "1000306216",
          "3030198397",
          "3018094310",
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          "1000514656",
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          "2246552",
          "2183319",
          "3004593495",
          "1526611",
          "3009183442",
          "3003174284"
        ],
        "device_name": "Pump, Infusion, Implanted, Programmable",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}