{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "191703",
      "product_res_number": "Z-0782-2022",
      "event_date_initiated": "2022-01-18",
      "event_date_created": "2022-03-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2026-05-04",
      "res_event_number": "89469",
      "product_code": "MXD",
      "k_numbers": [
        "K200795"
      ],
      "product_description": "LINQ II Insertable Cardiac Monitor",
      "code_info": "8 impacted devices with the following Serial number and GTIN\n\n1) Serial RLB035341G (GTIN 00763000060374)\n2) Serial RLB051224G (GTIN 00763000060374)\n3) Serial RLB059666G (GTIN 00763000060374)\n4) Serial RLB061064G (GTIN 00763000060374)\n5) Serial RLB061812G (GTIN 00763000060381)\n6) Serial RLB066367G (GTIN 00763000060374)\n7) Serial RLB091638G (GTIN 00763000060374)\n8) Serial RLB122769G (GTIN 00763000554002)",
      "firm_fei_number": "2182208",
      "recalling_firm": "Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)",
      "address_1": "8200 Coral Sea St Ne",
      "city": "Mounds View",
      "state": "MN",
      "postal_code": "55112-4391",
      "additional_info_contact": "Technical Services\n800-929-4043",
      "reason_for_recall": "Devices may lose functionality due to susceptibility to moisture ingress.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On or around January 18, 2002, in the United States, Medtronic will begin notifying notified customers of the field corrective action and patient management recommendations via 2-day UPS delivery.  Consignees were provided with proper patient management recommendations. Consignees are asked to complete and return a confirmation certification confirming they have received the notification.\nOutside the United States (OUS), communication will begin no later than 18-JAN-2022 using locally approved methods.",
      "product_quantity": "8 devices",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of NJ, NY, PA, and VA. The country of Italy.",
      "openfda": {
        "k_number": [
          "K163460",
          "K261074",
          "K193473",
          "K240693",
          "K210484",
          "K233320",
          "K231328",
          "K212008",
          "K200444",
          "K152995",
          "K160809",
          "K132649",
          "K210608",
          "K171514",
          "K230375",
          "K201865",
          "K200795",
          "K253516",
          "K230553",
          "K211304",
          "K251221",
          "K233562",
          "K170628",
          "K150614",
          "K162855",
          "K221962",
          "K221856",
          "K223630",
          "K143503",
          "K190548",
          "K160689",
          "K132960",
          "K252593"
        ],
        "registration_number": [
          "3015544746",
          "2017865",
          "3008973940",
          "9610139",
          "3004185781",
          "2182208",
          "3009380063",
          "1028232",
          "2124215",
          "3018094310",
          "9614453",
          "9616693"
        ],
        "fei_number": [
          "3015544746",
          "2017865",
          "3008973940",
          "3002618605",
          "3004185781",
          "2182208",
          "3009380063",
          "1028232",
          "3002806500",
          "2124215",
          "3018094310",
          "3002807576"
        ],
        "device_name": "Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1025",
        "device_class": "2"
      }
    }
  ]
}