{
  "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": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 14
    }
  },
  "results": [
    {
      "cfres_id": "199220",
      "product_res_number": "Z-1483-2023",
      "event_date_initiated": "2023-03-24",
      "event_date_posted": "2023-05-11",
      "recall_status": "Open, Classified",
      "res_event_number": "91922",
      "product_code": "NTE",
      "k_numbers": [
        "K220654"
      ],
      "product_description": "ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC",
      "code_info": "UDI/DI 20705032053508; Lot Numbers:  35262517, 35263334, 35264204, 35264222, 35265345.",
      "firm_fei_number": "1016427",
      "recalling_firm": "Cordis US Corp",
      "address_1": "14201 Nw 60th Ave",
      "city": "Miami Lakes",
      "state": "FL",
      "postal_code": "33014-2802",
      "additional_info_contact": "786-313-2000",
      "reason_for_recall": "There is a potential for separation of the ANGIOGUARD  RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.",
      "root_cause_description": "Vendor change control",
      "action": "The firm issued an Urgent MEDICAL DEVICE RECALL notice to it consignees on 03/24/2023 by letter.  The notice explained the issue and the hazard, and requested the following actions be taken:  \n- Check inventory and isolate the product to avoid use.\n- Complete and return the response form\n- Share this letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the affected units of product from your facility. If any units of the affected lots are found to be at the other facility, please arrange the return of the units. \n- Return any affected product\n\nUPDATED 5/15/2023:\n\nThe firm issued an updated letter dated 4/20/2023 since they extended the scope to include additional item and lot numbers, as well as removing some lot numbers.\n\nThe remainder of the letter was similar to the initial letter dated 3/24/2023 and also contained a response form for return.",
      "product_quantity": "283 units",
      "distribution_pattern": "Worldwide distribution.",
      "openfda": {
        "k_number": [
          "K153086",
          "K210282",
          "K083300",
          "K052659",
          "K062531",
          "K103500",
          "K081523",
          "K143072",
          "K082348",
          "K111987",
          "K220654",
          "K110909",
          "K081549",
          "K092177",
          "K200198",
          "K063313",
          "K072990",
          "K180023",
          "K222694",
          "K052165",
          "K120480",
          "K063204",
          "K111010",
          "K042218",
          "K141678",
          "K191173",
          "K052166",
          "K042908",
          "K153485",
          "K121015",
          "K052454",
          "K230402",
          "K123156",
          "K101651",
          "K143570",
          "K090665"
        ],
        "registration_number": [
          "2024168",
          "2126666",
          "3002807314",
          "2024024",
          "3007738736",
          "2134265",
          "2183744",
          "3011471056",
          "3012121095",
          "1319639",
          "3004859241",
          "9617601",
          "2939561",
          "3004091615",
          "3002806603",
          "2183870",
          "2011171",
          "3004742232",
          "3013666336",
          "1000121056",
          "3013944123",
          "3013556777",
          "2124215",
          "1016427",
          "3007695959"
        ],
        "fei_number": [
          "2024168",
          "2126666",
          "3002807314",
          "2024024",
          "3002095335",
          "3007738736",
          "2183744",
          "3011471056",
          "3012121095",
          "3004859241",
          "3004635528",
          "3004091615",
          "3002806603",
          "2183870",
          "2011171",
          "1000138054",
          "3004742232",
          "3002534070",
          "3013666336",
          "1000121056",
          "3013944123",
          "3013556777",
          "2124215",
          "1016427",
          "3007695959"
        ],
        "device_name": "Temporary Carotid Catheter For Embolic Capture",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1250",
        "device_class": "2"
      }
    }
  ]
}