{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "41814",
      "product_res_number": "Z-0461-06",
      "event_date_initiated": "2005-09-06",
      "event_date_posted": "2006-01-31",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-12-26",
      "res_event_number": "33406",
      "product_code": "MAE",
      "pma_numbers": [
        "P020024"
      ],
      "product_description": "AMPLATZER Duct Occluder,  Order No. 9-PDA-003, Device Size 5/4mm, Length 5 mm. Sterile EO.  Single Use Only.  Manufactured by AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN  55427 USA.  The AMPLATZER Duct Occluder is a self-expandable device made from a Nitinol wire mesh.  A retention skirt on the aortic side provides secure positioning in the ampulla of the ductus.  As the occluder is implanted, it expands outward and the wires push against the wall of the ductus.  Polyester fabric is sewn into the occluder with polyester thread.  The fabric induces thrombosis that closes the communication.",
      "code_info": "all lots",
      "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": "The pointed end of a screw securing the occluder to the delivery cable could scrape off microscopic fragments of the polytetrafluorethylene (PTFE) plastic lining of the sheath.  Those shavings could potentially migrate into a patient's bloodstream.",
      "root_cause_description": "Other",
      "action": "User facilities and distributors were notified via email beginning 09/06/05.  Additionally a hard copy of the recall letter was sent via certified mail or Federal Express.  AGA requests that the Response Form be completed and faxed or emailed back to them.  AGA Medical staff will assist users in returning product distributed within the US.",
      "product_quantity": "18,725 total",
      "distribution_pattern": "OUS to the following countries:  Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Denmark, El Salvador, Finland, France, Germany, Greece, Guatemala, Hungary, India, Indonesia, Isreal, Italy, Jordan, Korea, Kuwait, Malaysia, Mexico, Morocco, Netherlands, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Saudia Arabia, Singapore, Slovakia, South Africa, Spain, Sweeden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uruguay, Venezuela, Viet Nam and United Kingdom.",
      "openfda": {
        "pma_number": [
          "P120009",
          "P000039",
          "P020024"
        ],
        "registration_number": [
          "2135147",
          "3005704822",
          "3026560514",
          "2183744",
          "3010273872",
          "3013666218",
          "3014918977",
          "3007113487",
          "1928237",
          "3012179728",
          "1721676"
        ],
        "fei_number": [
          "3005704822",
          "3026560514",
          "2183744",
          "3010273872",
          "3013666218",
          "3014918977",
          "3007113487",
          "3005334138",
          "1928237",
          "3012179728",
          "1721676"
        ],
        "device_name": "Occluder, Patent Ductus, Arteriosus",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}