{
  "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": "203778",
      "product_res_number": "Z-0320-2024",
      "event_date_initiated": "2023-10-12",
      "event_date_posted": "2023-11-17",
      "recall_status": "Open, Classified",
      "res_event_number": "93258",
      "product_code": "NTE",
      "k_numbers": [
        "K092177"
      ],
      "product_description": "Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6",
      "code_info": "UDI/DI 08033477090719:  \nUDI/DI 00763000451691",
      "firm_fei_number": "3001504994",
      "recalling_firm": "Medtronic Inc",
      "address_1": "710 Medtronic Pkwy Mailstop Ls245",
      "city": "Minneapolis",
      "state": "MN",
      "postal_code": "55432-5603",
      "additional_info_contact": "PVH Customer Service\n800-716-6700",
      "reason_for_recall": "The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA) proximal balloon and external carotid artery (ECA) distal balloon inflation and deflation ports. Both sides of the complaint units manifold were labelled with the superior label leading to an incorrect identification of the proximal and distal inflation /deflation ports when viewing the devices from the inferior side.",
      "root_cause_description": "Process control",
      "action": "Medtronic issued an URGENT: MEDICAL DEVICE RECALL NOTIFICATION on 10/04/2023 via UPS.  The notice explained the issue, potential risk, and requested the return of the device.  For questions, consignees were directed to contact their Medtronic Field Sales Representative.",
      "product_quantity": "2767 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Algeria, Armenia, France, Germany, Iraq, Italy, Japan, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, United Kingdom.",
      "openfda": {
        "k_number": [
          "K092177",
          "K101651",
          "K083300",
          "K052454",
          "K052165",
          "K210282",
          "K052166",
          "K121015",
          "K110909",
          "K042908",
          "K042218",
          "K123156",
          "K143072",
          "K200198",
          "K230402",
          "K063313",
          "K052659",
          "K222694",
          "K090665",
          "K180023",
          "K081549",
          "K141678",
          "K062531",
          "K072990",
          "K220654",
          "K153485",
          "K191173",
          "K063204",
          "K081523",
          "K143570",
          "K111987",
          "K082348",
          "K120480",
          "K111010",
          "K153086",
          "K103500"
        ],
        "registration_number": [
          "2134265",
          "3013556777",
          "3002807314",
          "2126666",
          "3012121095",
          "2011171",
          "3013944123",
          "1000121056",
          "2124215",
          "3004091615",
          "3004859241",
          "3002806603",
          "3013666336",
          "3011471056",
          "2024024",
          "2939561",
          "2024168",
          "1016427",
          "1319639",
          "3004742232",
          "2183744",
          "3007738736",
          "3007695959",
          "2183870",
          "9617601"
        ],
        "fei_number": [
          "3013556777",
          "3004635528",
          "3002807314",
          "3002534070",
          "1000138054",
          "2126666",
          "3012121095",
          "3002095335",
          "2011171",
          "3013944123",
          "1000121056",
          "2124215",
          "3004091615",
          "3004859241",
          "3002806603",
          "3013666336",
          "3011471056",
          "2024024",
          "2024168",
          "1016427",
          "3004742232",
          "2183744",
          "3007738736",
          "3007695959",
          "2183870"
        ],
        "device_name": "Temporary Carotid Catheter For Embolic Capture",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1250",
        "device_class": "2"
      }
    }
  ]
}