{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 6
    }
  },
  "results": [
    {
      "cfres_id": "220206",
      "product_res_number": "Z-2325-2026",
      "event_date_initiated": "2026-05-01",
      "event_date_posted": "2026-06-05",
      "recall_status": "Open, Classified",
      "res_event_number": "98922",
      "product_code": "NIM",
      "pma_numbers": [
        "P240029"
      ],
      "product_description": "Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx30mm\nModel/Catalog Number: CND0830",
      "code_info": "UDI: 07290120281691; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026",
      "firm_fei_number": "3032814119",
      "recalling_firm": "INSPIREMD Inc",
      "address_1": "6303 Waterford District Dr Ste 215 6303 Waterford District Dr",
      "address_2": "Ste 215",
      "city": "Miami",
      "state": "FL",
      "postal_code": "33126-6004",
      "additional_info_contact": "InspireMD Customer Service \n1888-776-6804",
      "reason_for_recall": "Stent delivery system may encounter complications during deployment which may result in high resistance  or inability to deploy the stent.",
      "root_cause_description": "Component design/selection",
      "action": "On May 1, 2026, InspireMD, Inc. issued a Urgent Medical Device Recall notification to affected consignees. InspireMD asked consignees to take the following actions: \n\n1. Cease further use of all affected CGuard Prime Carotid Stent Systems identified by the\nmodel numbers listed in the letter.\n2. Quarantine and segregate all affected units currently in your inventory. Place affected\nproduct in a clearly labeled quarantine area to prevent inadvertent use.\n\n3. This notice needs to be passed on to all those who need to be aware within your\norganization or facilities where the affected devices have been transferred.\n\n4. Please retain a copy of this letter, and keep a copy of the Acknowledgement Form.\n\n5. Complete the attached Acknowledgement Form and return it by email to\nUSSupport@inspiremd.com within 2 business days.\n6. InspireMD will contact each affected customer to facilitate the return and disposition process.",
      "product_quantity": "190 units",
      "distribution_pattern": "US Nationwide distribution in the states of AR, AZ, CA, DC, FL, GA, HI, IL, IN, KS, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OR, RI, SD, TN, TX, VA, WA, WI, WV.",
      "openfda": {
        "pma_number": [
          "P040012",
          "P040038",
          "P140026",
          "P070012",
          "P180010",
          "P060001",
          "P050019",
          "P240009",
          "P030047",
          "P210030",
          "P240029",
          "P050025"
        ],
        "registration_number": [
          "3011471056",
          "1643817",
          "3004091615",
          "3015192261",
          "2024024",
          "3010173425",
          "3031658894",
          "9616099",
          "3010079067",
          "3013556777",
          "9681260",
          "2183744",
          "3022627847",
          "2124215",
          "3002807314",
          "2939561",
          "2183870",
          "2024168",
          "3009756327",
          "3010432890",
          "3003956144",
          "3012865735",
          "1424778",
          "2011171",
          "1016427"
        ],
        "fei_number": [
          "3002807036",
          "3011471056",
          "1643817",
          "3004091615",
          "3015192261",
          "2024024",
          "3031658894",
          "3010079067",
          "3013556777",
          "3004635528",
          "3003473227",
          "2183744",
          "3022627847",
          "2124215",
          "3002807314",
          "2183870",
          "3002807038",
          "2024168",
          "3002806565",
          "3010432890",
          "3003528016",
          "3003956144",
          "3012865735",
          "2011171",
          "1016427"
        ],
        "device_name": "Stent, Carotid",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}