{
  "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": {
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  "results": [
    {
      "cfres_id": "122556",
      "product_res_number": "Z-0154-2014",
      "event_date_initiated": "2013-10-07",
      "event_date_posted": "2013-11-05",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-02-11",
      "res_event_number": "66532",
      "product_code": "NIQ",
      "pma_numbers": [
        "P110013S005"
      ],
      "product_description": "Resolute Integrity Zotarolimus-eluting Coronary Stent:\nStent ID 3.0 mm; Stent length 34 mm; Rx, Sterile.\nMfg in Medtronic Ireland, Galaway, Ireland. Distributed by: Medtronic Inc.\nMinneapolis, MN.\n\nIndicated for improving coronary luminal diameters in patients.",
      "code_info": "Model: RSINT30034UX;  Customer Facing Number: RSIST30034UX. Expiration date: 25 May 2014.",
      "firm_fei_number": "3001452571",
      "recalling_firm": "Medtronic Vascular, Inc.",
      "address_1": "3576 Unocal Pl",
      "city": "Santa Rosa",
      "state": "CA",
      "postal_code": "95403-1774",
      "additional_info_contact": "Carlos Alfonso\n707-566-1110",
      "reason_for_recall": "A small number of units in lot number 0006573585 of the Resolute Integrity Zotarolimus-Eluting Coronary Sten System may contain a compliance chart incorrectly referencing a 2.25 mm diameter instead of the correct 3.0mm.",
      "root_cause_description": "Process control",
      "action": "Urgent Medical Device Recall  Letters were sent on October 7, 2013 via UPS 3-day service.",
      "product_quantity": "201 units",
      "distribution_pattern": "Nationwide Distribution.",
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        "device_name": "Coronary Drug-Eluting Stent",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}