{
  "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,
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  "results": [
    {
      "cfres_id": "159783",
      "product_res_number": "Z-0188-2018",
      "event_date_initiated": "2017-11-03",
      "event_date_created": "2017-11-29",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-09-01",
      "res_event_number": "78570",
      "product_code": "NIP",
      "pma_numbers": [
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      "product_description": "Everflex Self-Expanding Peripheral Stent with Entrust Delivery System\n Intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 - 7.5 mm.",
      "code_info": "Model No. EVD35-07-060-120, UDI 00821684051436, Lot No. A476328.    Model No. EVD35-07-120-120, UDI 00821684051467, Lot No. A476301.",
      "firm_fei_number": "2183870",
      "recalling_firm": "Medtronic Inc.",
      "address_1": "4600 Nathan Ln N",
      "city": "Plymouth",
      "state": "MN",
      "postal_code": "55442-2890",
      "additional_info_contact": "Krystin Hayward\n508-261-8000",
      "reason_for_recall": "Stent length on the label may not match the length of the stent itself.",
      "root_cause_description": "Employee error",
      "action": "Medtronic sent an Urgent Medical Device Recall letter on approximately 11/03/2017, via UPS 2-day delivery.  Instructions include identify and quarantine all unused affected product in inventory, return all unused affected product, and complete and return the Customer Confirmation Certificate.\nCustomers with questions regarding this communication, please contact\nyour Medtronic Field Representative.\nFor questions regarding this recall call 508-261-8000.",
      "product_quantity": "21 units",
      "distribution_pattern": "Nationwide Distribution to AZ, CA, GA, IA, IL, KY, MA, NC, NE, SC, TN, VA",
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