{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "204258",
      "product_res_number": "Z-0522-2024",
      "event_date_initiated": "2020-07-13",
      "event_date_posted": "2023-12-09",
      "recall_status": "Completed",
      "res_event_number": "93401",
      "product_code": "LKK",
      "pma_numbers": [
        "P860004"
      ],
      "product_description": "Medtronic SynchroMed, Model A10",
      "code_info": "GTIN 00643169771031, All serial numbers with software version 1.1.300.",
      "firm_fei_number": "2182208",
      "recalling_firm": "Medtronic Inc.",
      "address_1": "8200 Coral Sea St Ne",
      "city": "Mounds View",
      "state": "MN",
      "postal_code": "55112-4391",
      "additional_info_contact": "Medtronic Customer Service\n800-962-9888",
      "reason_for_recall": "The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens:  Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm.",
      "root_cause_description": "Software Design Change",
      "action": "Medtronic issued a SAFETY NOTIFICATION to its consignees on 07/13/2020 by letter.  The notice explained the problem with the device and requested the software be upgraded to  version 1.1.342.",
      "product_quantity": "2543 units",
      "distribution_pattern": "Foreign Distribution",
      "openfda": {
        "pma_number": [
          "P990034",
          "P860004",
          "P140032",
          "P890055",
          "P800036",
          "P080012"
        ],
        "registration_number": [
          "2135338",
          "2246552",
          "1722746",
          "3018094310",
          "3007829657",
          "2182207",
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        ],
        "fei_number": [
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          "3005700659",
          "3018094310",
          "3007829657",
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        ],
        "device_name": "Pump, Infusion, Implanted, Programmable",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}