{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "132047",
      "product_res_number": "Z-0879-2015",
      "event_date_initiated": "2014-12-04",
      "event_date_posted": "2014-12-29",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-07-17",
      "res_event_number": "69965",
      "product_code": "NIM",
      "pma_numbers": [
        "P060001"
      ],
      "product_description": "ev3, Protg Rx Tapered Carotid Stent System,  SEPX-8-6-40-135, Sterile EO, Rx only.\n\nIndicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.",
      "code_info": "Lot # 9922795",
      "firm_fei_number": "2183870",
      "recalling_firm": "Ev3, Inc.",
      "address_1": "4600 Nathan Ln N",
      "city": "Plymouth",
      "state": "MN",
      "postal_code": "55442-2890",
      "additional_info_contact": "Rhonda Luniak\n303-305-2263",
      "reason_for_recall": "Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 & SEPX-8-6-40-135, Lot # 9922795) because of a product labeling error.",
      "root_cause_description": "Packaging process control",
      "action": "Consignees were sent on 12/4/2014 a Covidien \"Urgent Field Safety Notice\" letter dated 4th December 2014.  The letter described the problem and the product involved in the recall.  Advised consignees to quarantine, discontinue use of the device and return the product to Covidien.  They also requested consignees to complete the \"Recall Verification Form\" and return it to Covidien. For questions, customers can contact their local Covidien Representative.",
      "product_quantity": "24",
      "distribution_pattern": "International Only Distribution -- RUSSIA, ROMANIA, UNITED KINGDOM, GERMANY, ITALY, SPAIN, FRANCE, TURKEY, POLAND, and JAPAN.",
      "openfda": {
        "pma_number": [
          "P040012",
          "P030047",
          "P070012",
          "P180010",
          "P140026",
          "P060001",
          "P040038",
          "P210030",
          "P050019",
          "P050025",
          "P240029",
          "P240009"
        ],
        "registration_number": [
          "3010432890",
          "2011171",
          "1424778",
          "3010079067",
          "3009756327",
          "3011471056",
          "1643817",
          "3013556777",
          "3015192261",
          "2124215",
          "1016427",
          "9616099",
          "3031658894",
          "2024168",
          "2183744",
          "3004091615",
          "3010173425",
          "2939561",
          "2024024",
          "3022627847",
          "3002807314",
          "9681260",
          "3003956144",
          "2183870",
          "3012865735"
        ],
        "fei_number": [
          "3010432890",
          "2011171",
          "3010079067",
          "3011471056",
          "1643817",
          "3013556777",
          "3015192261",
          "3003528016",
          "2124215",
          "1016427",
          "3002806565",
          "3003473227",
          "3031658894",
          "2024168",
          "2183744",
          "3004091615",
          "2024024",
          "3002807038",
          "3022627847",
          "3002807314",
          "3004635528",
          "3002807036",
          "3003956144",
          "2183870",
          "3012865735"
        ],
        "device_name": "Stent, Carotid",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}