{
  "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": "168166",
      "product_res_number": "Z-0407-2019",
      "event_date_initiated": "2018-10-02",
      "event_date_created": "2018-11-08",
      "recall_status": "Open, Classified",
      "res_event_number": "81300",
      "product_code": "OSR",
      "pma_numbers": [
        "P890003S398"
      ],
      "product_description": "Medtronic CareLink Encore 29901 Programmer",
      "code_info": "All Serial Numbers",
      "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": "Medtronic Instruments \n800-638-1991",
      "reason_for_recall": "Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download.",
      "root_cause_description": "Software design",
      "action": "The firm began disseminating the Field Corrective Action notices by hand delivery on 10/02/2018 and followed with the posting of Medtronic Security Bulletin and the Urgent Medical Device Correction customer letter online on 10/11/2018.\n\nThe notice explained vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download and beginning October 11th, 2018, Medtronic will be disabling the SDN for programmer updates and will rely solely on the USB update method.",
      "product_quantity": "4072 units",
      "distribution_pattern": "Worldwide",
      "openfda": {
        "pma_number": [
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          "P980049",
          "P150035",
          "P010031",
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        ],
        "device_name": "Pacemaker/Icd/Crt Non-Implanted Components",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}