{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "122631",
      "product_res_number": "Z-0268-2014",
      "event_date_initiated": "2013-10-21",
      "event_date_posted": "2013-11-15",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-12-15",
      "res_event_number": "66567",
      "product_code": "DQT",
      "k_numbers": [
        "K983927"
      ],
      "product_description": "ZINGER Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZRMS180S, LVZRXT180J, LVZRXT180S\n\nMedtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.",
      "code_info": "G13A00118 G13A00715 G13A00716 G13A00843 G13A00937 G13A01601 G13A01620 G13A01621 G13A01638 G13A01639 G13A01650 GV854 GW761",
      "firm_fei_number": "1220452",
      "recalling_firm": "Medtronic Vascular",
      "address_1": "35-37A Cherry Hill Drive",
      "city": "Danvers",
      "state": "MA",
      "postal_code": "01923-2565",
      "additional_info_contact": "978-777-0042",
      "reason_for_recall": "Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "The firm, Medtronic, sent a \"URGENT MEDICAL DEVICE RECALL\" letter dated October 21, 2013 (in the US via UPS overnight service, 1-day delivery) to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately remove and quarantine all potentially affected guidewires that remain in inventory;  return the affected product to Medtronic; if replacement product is needed, your Medtronic representative can assist you with identifying suitable replacement product, and to complete and return the Customer Confirmation Certificate confirming  receipt of the notification via fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality (100% customer confirmations will be required).\n\nShould have any questions, please contact your Medtronic Representative or call 763-526-2513.\n\nNotifications to customers concerning the additional affected product began December 19, 2013 (in the US via UPS overnight service, 1-day delivery). Customers are requested to return a Confirmation Certificate confirming\ntheir receipt of the notification. 100% customer confirmations will be required from the additional consignees.",
      "product_quantity": "5",
      "distribution_pattern": "Worldwide distribution: US (Nationwide) including states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV; and countries of: Albania, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guyana, Honduras, Hong Kong,Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mexico, Montenegro, Nepal, Netherlands, New Zealand, Nepal, Nicaragua, Norway, Oman, Poland, Portugal Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Kingdom, Uruguay, and Yemen.",
      "openfda": {
        "k_number": [
          "K863559",
          "K844918",
          "K872790",
          "K872090",
          "K945963",
          "K840795",
          "K983927",
          "K910916",
          "K880231",
          "K872154",
          "K910339",
          "K880860"
        ],
        "registration_number": [
          "",
          "1220948",
          "3011137372",
          "1319639",
          "3010041511"
        ],
        "fei_number": [
          "",
          "1220948",
          "1000138054",
          "3005747797",
          "3010041511"
        ],
        "device_name": "Occluder, Catheter Tip",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1370",
        "device_class": "2"
      }
    }
  ]
}