{
  "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": "130243",
      "product_res_number": "Z-0125-2015",
      "event_date_initiated": "2014-09-20",
      "event_date_posted": "2014-11-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-12-04",
      "res_event_number": "69326",
      "product_code": "MIH",
      "pma_numbers": [
        "P120006"
      ],
      "product_description": "Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts.\r\n\r\nThe TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device delivered via catheter to treat descending abdominal aortic aneurysms (AAAs).",
      "code_info": "The devices subject to this action are labeled for distribution outside of the United States; therefore, no UDI is on the device label or package.  Model Number: TV-AB2980-D  Lot Numbers: FS031814-11 FS052214-22 FS052814-36 FS040414-21 FS050614-56 FS040714-53 FS040514-02 FS042614-05 FS050614-53 FS032614-46 FS050214-27 FS050314-12 FS052214-48 FS052214-53 FS031814-44 FS031814-49 FS032714-04 FS032714-20 FS040414-30 FS040514-08 FS050114-01 FS050114-08 FS050514-18 FS050514-27 FS050614-54 FS050614-55 FS051914-32 FS051914-34  Expiry dates ranging \"May-17\" through \"Jun-17\"",
      "firm_fei_number": "3008011247",
      "recalling_firm": "Trivascular, Inc",
      "address_1": "3910 Brickway Blvd",
      "city": "Santa Rosa",
      "state": "CA",
      "postal_code": "95403",
      "additional_info_contact": "Tim Doolin\n707-543-8732",
      "reason_for_recall": "TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be associated with rapid emptying of the fill polymer syringe when it is connected to the Autoinjector during the fill polymer injection step of the primary implant procedure.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Urgent Field Safety Notice letter was sent to all consignees on 9/19/14 via trackable mail system.  Users are notified that TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be associated with rapid emptying of the fill polymer syringe when it is connected to the Autoinjector during the fill polymer injection step of the primary implant procedure.",
      "product_quantity": "0 Devices",
      "distribution_pattern": "International  Distribution Only -- Canada, Turkey, Austria, Ireland, Belgium, Italy, Switzerland, Spain, France, and Cyprus.",
      "openfda": {
        "device_name": "System, Endovascular Graft, Aortic Aneurysm Treatment",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
          "P110038",
          "P140016",
          "P070007",
          "P180001",
          "P040002",
          "P040043",
          "P120006",
          "P110032",
          "P020018",
          "P100021",
          "P100040",
          "P200030",
          "P150002",
          "P990020",
          "P990017",
          "P210032",
          "P190015",
          "P070027",
          "P020004",
          "P200045",
          "P070016"
        ],
        "registration_number": [
          "1820334",
          "3004497303",
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        ]
      }
    }
  ]
}