{
  "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": "209992",
      "product_res_number": "Z-0024-2025",
      "event_date_initiated": "2024-09-09",
      "event_date_posted": "2024-10-07",
      "recall_status": "Open, Classified",
      "res_event_number": "95329",
      "product_code": "PRL",
      "product_description": "iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616",
      "code_info": "UDI-DI: 00650862426168;\nLot Number: 508083;\nSerial Numbers: 508083031, 508083032, 508083034, 508083035, 508083036, 508083037, 508083038, 508083039, 508083040, 508083041, 508083042",
      "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": "973-709-6929",
      "reason_for_recall": "There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.",
      "root_cause_description": "Under Investigation by firm",
      "action": "An Urgent Medical Device Removal notification letter dated 9/9/24 was sent to customers.\n\nActions to be taken by the Customer:\nOur records indicate that you have received one or more of the iCast Covered Stents from the affected Product REF and Serial Numbers.\nPlease examine your inventory immediately to determine if you have any of the iCast Covered Stents with the Product REF and Serial Numbers listed in this notice, which can be found on the product label.\n\n\" Should you have any affected product, do not use the product and remove it from areas of use.\n\" Please forward this information to all current and potential iCast Covered Stent System users within your hospital/ facility.\n\" If you are a distributor who has shipped any affected product(s) to customers, please forward this document to their attention for appropriate action.\n\" Please contact your local Atrium Medical Corporation/Getinge Customer Support department at (888) 943-8872 (press option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone) to receive instructions for returning any affected unused product within expiry per the iCast label. You will receive credit upon the return of any affected devices.\n\" Whether or not you have affected product(s) with the Product REF number and Serial Numbers listed in this notice, please complete and sign the attached MEDICAL DEVICE - REMOVAL RESPONSE FORM to acknowledge that you have received this notification. Return the completed form to Getinge by emailing a scanned copy to\n trium.icastcooklabel.act@getinge.com.\n\nType of Action by Atrium Medical Corporation/Getinge:\nIf requested, Atrium Medical Corporation/Getinge will facilitate the removal of affected products from your facility and provide credit for your return of these products.\n\nIf you have any questions, please call Atrium Medical Corporation/Getinge Customer Support at (888) 943-8872 (press option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m.",
      "product_quantity": "11 devices",
      "distribution_pattern": "US Nationwide distribution in the states of FL, MA, MI, OH, WA.",
      "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"
      }
    }
  ]
}