{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Bloomington",
      "state": "IN",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "77099",
      "recalling_firm": "Cook Medical Incorporated",
      "address_1": "400 N Daniels Way",
      "address_2": "N/A",
      "postal_code": "47404-9155",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution.",
      "recall_number": "Z-2099-2017",
      "product_description": "Zenith Alpha Thoracic Endovascular Graft    The Zenith Alpha\" Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta (not including dissections) having vascular anatomy suitable for endovascular repair including: \" Iliac/femoral anatomy that is suitable for access with the required introduction systems, \" Nonaneurysmal aortic segments (fixation sites) proximal and distal to the thoracic lesion: \" with a length of at least 20 mm, and \" with a diameter measured outer wall to outer wall of no greater than 42 mm and no less than 15 mm.",
      "product_quantity": "4916",
      "reason_for_recall": "There have been five reports of graft thrombosis/occlusion during  global commercial use, each following treatment for BTAI.  One case resulted in patient death, and three cases resulted in  reintervention.",
      "recall_initiation_date": "20170322",
      "center_classification_date": "20170809",
      "termination_date": "20190214",
      "report_date": "20170816",
      "code_info": "All lots.  Catalog Numbers:  ZTA-D-28-160-W  ZTA-D-28-229-W  ZTA-D-30-160-W  ZTA-D-30-229-W  ZTA-D-32-160-W  ZTA-D-32-229-W  ZTA-D-34-142-W  ZTA-D-34-190-W  ZTA-D-36-142-W  ZTA-D-36-190-W  ZTA-D-38-147-W  ZTA-D-38-197-W  ZTA-D-40-147-W  ZTA-D-40-197-W  ZTA-D-42-152-W  ZTA-D-42-204-W  ZTA-D-44-157-W  ZTA-D-44-211-W  ZTA-D-46-157-W  ZTA-D-46-211-W  ZTA-DE-18-104-W  ZTA-DE-18-148-W  ZTA-DE-20-104-W  ZTA-DE-20-148-W  ZTA-DE-22-104-W  ZTA-DE-22-148-W  ZTA-DE-24-104-W  ZTA-DE-24-148-W  ZTA-DE-26-104-W  ZTA-DE-26-148-W  ZTA-DE-28-108-W  ZTA-DE-28-154-W  ZTA-DE-30-108-W  ZTA-DE-30-154-W  ZTA-DE-32-108-W  ZTA-DE-32-154-W  ZTA-DE-34-112-W  ZTA-DE-34-160-W  ZTA-DE-36-112-W  ZTA-DE-36-160-W  ZTA-DE-38-141-W  ZTA-DE-38-91-W  ZTA-DE-40-141-W  ZTA-DE-40-91-W  ZTA-DE-42-146-W  ZTA-DE-42-94-W  ZTA-DE-44-151-W  ZTA-DE-44-97-W  ZTA-DE-46-151-W  ZTA-DE-46-97-W  ZTA-P-18-105-W  ZTA-P-18-127-W  ZTA-P-20-105-W  ZTA-P-20-127-W  ZTA-P-22-105-W  ZTA-P-22-127-W  ZTA-P-24-105-W  ZTA-P-24-127-W  ZTA-P-26-105-W  ZTA-P-26-149-W  ZTA-P-28-109-W  ZTA-P-28-132-W  ZTA-P-28-155-W  ZTA-P-28-201-W  ZTA-P-30-109-W  ZTA-P-30-132-W  ZTA-P-30-155-W  ZTA-P-30-201-W  ZTA-P-32-109-W  ZTA-P-32-132-W  ZTA-P-32-155-W  ZTA-P-32-201-W  ZTA-P-34-113-W  ZTA-P-34-137-W  ZTA-P-34-161-W  ZTA-P-34-209-W  ZTA-P-36-113-W  ZTA-P-36-137-W  ZTA-P-36-161-W  ZTA-P-36-209-W  ZTA-P-38-117-W  ZTA-P-38-142-W  ZTA-P-38-167-W  ZTA-P-38-217-W  ZTA-P-40-117-W  ZTA-P-40-142-W  ZTA-P-40-167-W  ZTA-P-40-217-W  ZTA-P-42-121-W  ZTA-P-42-147-W  ZTA-P-42-173-W  ZTA-P-42-225-W  ZTA-P-44-125-W  ZTA-P-44-152-W  ZTA-P-44-179-W  ZTA-P-44-233-W  ZTA-P-46-125-W  ZTA-P-46-152-W  ZTA-P-46-179-W  ZTA-P-46-233-W  ZTA-PT-22-18-105-W  ZTA-PT-26-22-105-W  ZTA-PT-30-26-108-W  ZTA-PT-32-28-178-W  ZTA-PT-32-28-201-W  ZTA-PT-34-30-161-W  ZTA-PT-34-30-209-W  ZTA-PT-36-32-161-W  ZTA-PT-36-32-209-W  ZTA-PT-38-34-167-W  ZTA-PT-38-34-217-W  ZTA-PT-40-36-167-W  ZTA-PT-40-36-217-W  ZTA-PT-42-38-173-W  ZTA-PT-42-38-225-W  ZTA-PT-44-40-179-W  ZTA-PT-44-40-233-W  ZTA-PT-46-42-179-W  ZTA-PT-46-42-233-W"
    }
  ]
}