{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "43565",
      "product_res_number": "Z-0894-06",
      "event_date_initiated": "2005-08-16",
      "event_date_posted": "2006-06-02",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-12-26",
      "res_event_number": "34337",
      "product_code": "DXE",
      "k_numbers": [
        "K901502"
      ],
      "product_description": "Amplatz Goose Neck Microsnare Kit,  Model SK400 (175 cm length x 4mm loop snare x .018'',0.46mm) and SK701 (200 cm length x 7mm loop snare x 0.18'' x 0.46mm) ev3, 4600 Nathan Lane North, Plymouth, Minnesota, 55442-2920 USA. For one time use only. Sterilization with Ethylene Oxide gas.  Do not resterilize.------The Amplatz Goose Neck Microsnare Kit contains one Amplatz Goose Neck Microsnare, one Microcatheter, one Microsnare Introducer and one torque device.",
      "code_info": "Model SK400, Lot number 277755;   Model KS701, Lot number 575327",
      "firm_fei_number": "2183870",
      "recalling_firm": "Ev3, Inc",
      "address_1": "4600 Nathan Ln N",
      "city": "Plymouth",
      "state": "MN",
      "postal_code": "55442-2890",
      "reason_for_recall": "ev3 has determined that one test unit from each of two lots did not meet mininum tensile strength requirements and therefore the entire lots are being recalled.",
      "root_cause_description": "Other",
      "action": "The recall was initiated on August 16, 2005.  All units distributed have been accounted for and the firm completed the recall on December 29, 2005.  The firm sent a notification to customers with a Device Recall Field Action Form to record if devices remain at the sight and include with devices returned for credit or replacement.",
      "product_quantity": "58",
      "distribution_pattern": "AL, AR, CA, CO, FL, IL, KS, MA, MO, NY, PA, TX, WA, VA,  Canada, Germany, Japan",
      "openfda": {
        "k_number": [
          "K853625",
          "K992934",
          "K864330",
          "K020634",
          "K972572",
          "K812640",
          "K011783",
          "K883852",
          "K901502",
          "K894681",
          "K961716",
          "K832023",
          "K163353",
          "K900311",
          "K914880",
          "K920823",
          "K992933",
          "K920871",
          "K002627",
          "K202049",
          "K954760",
          "K955125",
          "K801650",
          "K193379",
          "K961883",
          "K891021",
          "K770569",
          "K780762",
          "K974335",
          "K935405",
          "K864062",
          "K790838",
          "K163031",
          "K893680",
          "K973477",
          "K081573",
          "K992368",
          "K770714",
          "K973465",
          "K840198",
          "K881455",
          "K233819",
          "K152335",
          "K241330",
          "K971314",
          "K233619",
          "K850015",
          "K961992",
          "K213771",
          "K892410",
          "K982141",
          "K950586",
          "K240078",
          "K872485",
          "K902327",
          "K901625",
          "K780244",
          "K970657",
          "K970762",
          "K901627",
          "K233820",
          "K761031",
          "K905139",
          "K022145",
          "K897184",
          "K832044",
          "K864007",
          "K100840",
          "K972623",
          "K910372",
          "K972511",
          "K992940",
          "K820646",
          "K100842"
        ],
        "registration_number": [
          "",
          "9617465",
          "1018233",
          "2029386",
          "1220452",
          "3009051888",
          "3030714660",
          "1319639",
          "1724474",
          "3005704822",
          "2183870",
          "1820334",
          "3008496528",
          "8043983",
          "3012050423",
          "3032916632",
          "2648045",
          "2024311",
          "3045042524",
          "3010041511",
          "1220948",
          "3015225571",
          "2522007",
          "2183744",
          "3006950086",
          "9680794",
          "1721686",
          "3015309643",
          "3033589330",
          "2027111",
          "3015859709",
          "3006082230",
          "9615817",
          "3035111606",
          "3013666218",
          "2015691",
          "1721504",
          "3012536737",
          "1061124",
          "1000393132",
          "3011137372"
        ],
        "fei_number": [
          "",
          "1018233",
          "3005747797",
          "1220452",
          "1000138054",
          "3003081151",
          "3009051888",
          "3030714660",
          "3005704822",
          "2183870",
          "1820334",
          "3008496528",
          "3012050423",
          "3032916632",
          "2648045",
          "2024311",
          "3003094851",
          "3045042524",
          "3016261803",
          "3010041511",
          "1220948",
          "3015225571",
          "2522007",
          "1000512168",
          "2183744",
          "3006950086",
          "1721686",
          "3015309643",
          "3033589330",
          "2027111",
          "3015859709",
          "3006082230",
          "3035111606",
          "3013666218",
          "2015691",
          "1721504",
          "3003737899",
          "3003769549",
          "3012536737",
          "1000306647",
          "1000393132"
        ],
        "device_name": "Catheter, Embolectomy",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.5150",
        "device_class": "2"
      }
    }
  ]
}