{
  "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": "2026-09-17",
    "results": {
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      "cfres_id": "188051",
      "product_res_number": "Z-2102-2021",
      "event_date_initiated": "2021-06-01",
      "event_date_created": "2021-07-20",
      "recall_status": "Open, Classified",
      "res_event_number": "88175",
      "product_code": "MXD",
      "k_numbers": [
        "K162855"
      ],
      "product_description": "Medtronic Reveal LINQ LNQ11 / PA96000",
      "code_info": "All serial numbers distributed on or after February 23, 2017    GTIN:  643169845763, 643169845770, 643169845787, 643169845794, 643169845800, 643169845817, 643169845824, 00643169845831, 00643169845848, 00643169845855, 00643169845862, 00643169845879, 00643169845893, 00763000188382, 00763000188399, 00763000188405, 00763000188412, 00763000188429, 00763000188436, 00763000188443, 00763000188450, 00763000188467, 643169845688, 643169845695, 643169845701, 643169845718, 643169845732, 643169845749, 643169845756",
      "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": "Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed \"ON\", but are no longer able to detect and report Brady and Pause events to clinicians.",
      "root_cause_description": "Software design",
      "action": "The firm began notifying their consignees on 06/02/2021 by letter.  The letter explained the issue, provided patient  management recommendations, and reported that a software update was anticipated in late 2021.  For questions, contact your local Medtronic Representative or Medtronic Technical Services at 800-929-4043.",
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      "distribution_pattern": "Worldwide Distribution",
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        "device_name": "Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)",
        "medical_specialty_description": "Cardiovascular",
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