{
  "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,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "48567",
      "product_res_number": "Z-0053-2007",
      "event_date_initiated": "2006-06-01",
      "event_date_posted": "2006-10-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-04-01",
      "res_event_number": "35814",
      "product_code": "MLV",
      "product_description": "AMPLATZER PFO Occluder.  Order No. 9-PFO-025.   Device is not PMA approved in the US.  25mm Sterile EO.   The AMPLATZER PFO Occluder is a self-expandable, double disc device made from a Nitinol wire mesh.  AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN  55427 USA.",
      "code_info": "Lot number M06B01-58, serial numbers 190495 - 190512",
      "firm_fei_number": "3005334138",
      "recalling_firm": "AGA Medical Corporation",
      "address_1": "682 Mendelssohn Ave N",
      "city": "Golden Valley",
      "state": "MN",
      "postal_code": "55427-4306",
      "reason_for_recall": "AMPLATZER PFO Occluders were mislabeled with incorrect device sizes.    The lot M06B01-58 contains 18mm PFO Occluders but is labeled as containing 25mm devices.  Lot M06B01-52 contains 25mm PFO Occluders but is labeled as containing 18mm devices. The affected product was not distributed within the United States and does not affect U.S. consignees.",
      "root_cause_description": "Other",
      "action": "Consignees were notified of the recall via fax and mail.  Consignees were instructed to cease distribution and use of the devices.  Returned devices will be replaced.",
      "product_quantity": "18",
      "distribution_pattern": "Foreign Distribution ONLY-Product was distributed in Italy, Switzerland, Germany and the Slovak Republic.",
      "openfda": {
        "device_name": "Transcatheter Septal Occluder",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
          "P000039",
          "P120021",
          "P050006",
          "P000049",
          "P040040"
        ],
        "registration_number": [
          "3005704822",
          "3010273872",
          "2135147",
          "3007113487",
          "3014918977",
          "3012179728",
          "1928237",
          "1721676",
          "2183744",
          "2011171",
          "2017233"
        ],
        "fei_number": [
          "3005704822",
          "3010273872",
          "3007113487",
          "3014918977",
          "3012179728",
          "3005334138",
          "1928237",
          "1721676",
          "2183744",
          "2011171",
          "2017233"
        ]
      }
    }
  ]
}