{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Mounds View",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87654",
      "recalling_firm": "Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)",
      "address_1": "8200 Coral Sea St Ne",
      "address_2": "N/A",
      "postal_code": "55112-4391",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide",
      "recall_number": "Z-1523-2021",
      "product_description": "CRT-P Quad Models (CRT-Ps):  a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04   b. Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05  c. Solara CRT-P MRI: W1TR03, W1TR06, W4TR03, W4TR06.    implantable medical devices used to treat arrhythmias related to bradycardia, and cardiac resynchronization therapy (CRT)",
      "product_quantity": "45,411 devices",
      "reason_for_recall": "There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).",
      "recall_initiation_date": "20210406",
      "center_classification_date": "20210430",
      "report_date": "20210512",
      "code_info": "all serial numbers"
    }
  ]
}