{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "203631",
      "product_res_number": "Z-0291-2024",
      "event_date_initiated": "2023-09-21",
      "event_date_posted": "2023-11-11",
      "recall_status": "Open, Classified",
      "res_event_number": "93195",
      "product_code": "PRL",
      "pma_numbers": [
        "P120003"
      ],
      "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.\nREF: 85361",
      "code_info": "UDI-DI: 00650862853612\nLot Numbers:\n464909, 464910",
      "firm_fei_number": "3011175548",
      "recalling_firm": "Atrium Medical Corporation",
      "address_1": "40 Continental Blvd",
      "city": "Merrimack",
      "state": "NH",
      "postal_code": "03054-4332",
      "additional_info_contact": "SAME\n603-880-1433",
      "reason_for_recall": "Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.",
      "root_cause_description": "Device Design",
      "action": "Atrium/Getinge issued URGENT Field Safety Notice -MEDICAL DEVICE REMOVAL on 9/25/23. Letter states reason for recall, health risk and action to take:\nPlease examine your inventory immediately to determine if you have any of the Advanta V12 covered stent\nproduct listed above. Should you have any affected product, please remove from area(s) of use.\n If you have affected product, you are entitled to a replacement at no cost to your facility or credit. You will\nreceive a replacement/credit upon your acknowledgement that you have affected product for return.\n If you are a distributor who has shipped any affected products to customers, please forward this document to\ntheir attention for appropriate action.\n Once your customer response form has been received you will be contacted with shipping instructions to return\nany affected product.\n Whether or not you have affected product(s) with a LOT number listed in this notice, please complete and sign\nthe attached MEDICAL DEVICE- REMOVAL RESPONSE FORM (page 3) to acknowledge that you have received this\nnotification. Return the completed form to Atrium/Getinge to tony.hawkins@getinge.com\nType of Action by Getinge:\nAtrium/Getinge has identified the cause of the issue and has implemented corrective measures to resolve the\nnoted manufacturing deficiency in the welding process, as well as additional detection measures implemented\nto detect balloon weld defects. These corrective actions were implemented September 09, 2020. Product\nManufactured through the welding process after September 09, 2020 is not affected by this recall. If you have affected product, you will receive a replacement at no cost to your facility, or credit.\n\nIf you have any questions, please contact your Getinge representative or office.",
      "product_quantity": "141 units",
      "distribution_pattern": "Foreign: Australia, Belgium, Canada, France, Germany, Greece, Malta, Netherlands, New Zealand, Portugal, and United Kingdom",
      "openfda": {
        "pma_number": [
          "P120003",
          "P160024",
          "P160021"
        ],
        "registration_number": [
          "1220477",
          "3002807314",
          "3006082230",
          "9616666",
          "2020394",
          "2134244",
          "3005580113",
          "1018233",
          "2017233",
          "3009937642",
          "2011171",
          "3011175548"
        ],
        "fei_number": [
          "1220477",
          "3002807314",
          "3006082230",
          "3008906816",
          "2020394",
          "3005580113",
          "1018233",
          "2017233",
          "3003407487",
          "3009937642",
          "2011171",
          "3011175548"
        ],
        "device_name": "Iliac Covered Stent, Arterial",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}