{
  "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,
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  "results": [
    {
      "cfres_id": "194374",
      "product_res_number": "Z-1480-2022",
      "event_date_initiated": "2020-11-05",
      "event_date_posted": "2022-07-28",
      "recall_status": "Open, Classified",
      "res_event_number": "90429",
      "product_code": "NIK",
      "pma_numbers": [
        "P010031S674"
      ],
      "product_description": "Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)",
      "code_info": "GTIN 00763000178178, Serial Numbers:  RTK601865S, RTK601825S, RTK601828S",
      "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": "763-505-6000",
      "reason_for_recall": "Manufacturing error that may have resulted in a cathode component being out of specification.  All devices met final functional testing requirements.",
      "root_cause_description": "Process control",
      "action": "On 05-Nov-2020, Medtronic initiated retrieval activities via verbal communication to consignees who were in possession of unused, affected devices according to Medtronic records. Consignees were advised to quarantine all affected devices within their possession.\nIn the United States, a written communication was mailed to two (2) identified consignees on 24-Nov-2020, directing the return of all unused, affected devices.",
      "product_quantity": "3 units",
      "distribution_pattern": "US Nationwide distribution in the states of Indiana and CA.",
      "openfda": {
        "device_name": "Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
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