{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Merrimack",
      "state": "NH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "93195",
      "recalling_firm": "Atrium Medical Corporation",
      "address_1": "40 Continental Blvd",
      "address_2": "N/A",
      "postal_code": "03054-4332",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Foreign: Australia, Belgium, Canada, France, Germany, Greece, Malta, Netherlands, New Zealand, Portugal, and United Kingdom",
      "recall_number": "Z-0291-2024",
      "product_description": "Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm  (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. Renal approval includes 5mm, 6mm and 7mm diameter Advanta V12 covered stent sizes. In Canada, the Advanta V12 Covered Stent indication excludes renal arteries.  REF: 85361",
      "product_quantity": "141 units",
      "reason_for_recall": "Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.",
      "recall_initiation_date": "20230921",
      "center_classification_date": "20231110",
      "report_date": "20231122",
      "code_info": "UDI-DI: 00650862853612 Lot Numbers: 464909, 464910"
    }
  ]
}