{
  "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": "2026-09-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "221400",
      "product_res_number": "Z-2911-2026",
      "event_date_initiated": "2026-06-29",
      "event_date_posted": "2026-08-06",
      "recall_status": "Open, Classified",
      "res_event_number": "99353",
      "product_code": "NIM",
      "pma_numbers": [
        "P240009"
      ],
      "product_description": "Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV-6-30, NG-NV-6-40, NG-NV-7-30, NG-NV-7-40",
      "code_info": "REF/UDI-DI/Lot:\nNG-0630-140-2/00851616007583/Z2460578D,Z2460740B, Z2460872C, Z2460909F, Z2460948D, Z2460957Q;\n\nNG-0640-140-2/00851616007590/Z2460578E,  Z2460647S, Z2460706A, Z2460746C, Z2460774A, Z2460865C, Z2460872B, Z2460901B, Z2460909D, Z2460909K, Z2460945H, Z2460948I, Z2460963N;\n\nNG-0730-140-2/00851616007606/Z2460578F, Z2460662A, Z2460740A , Z2460774F, Z2460850A, Z2460900B, Z2460945F, Z2460957R;\n\nNG-0740-140-2/00851616007613/Z2460578G, Z2460635C, Z2460656A, Z2460707D, Z2460733A, Z2460766A, Z2460774B, Z2460780A ,  Z2460865A, Z2460871A, Z2460872D, Z2460900D, Z2460909B, Z2460909I, Z2460948F, Z2460963T;\n\nNG-NV-6-30/00851616007644/Z2460776A, Z2460893A, Z2460909G, Z2460948E;\n\nNG-NV-6-40/00851616007651/Z2460776B, Z2460865D, Z2460865E, Z2460901C, Z2460909E, Z2460909J, Z2460957P, Z2460963K, Z2460963P;\n\nNG-NV-7-30/00851616007637/Z2460776C, Z2460789H, Z2460850B, Z2460900C, Z2460916A, Z2460948H, Z2460998A;\n\nNG-NV-7-40/00851616007620/Z2460776D, Z2460878A, Z2460872A, Z2460872E, Z2460901A, Z2460909C, Z2460909H, Z2460945G, Z2460948G, Z2460966B, Z2460963J;",
      "firm_fei_number": "3011471056",
      "recalling_firm": "Contego Medical, Inc",
      "address_1": "3801 Lake Boone Trl Ste 100 3801 Lake Boone Trl",
      "address_2": "Ste 100",
      "city": "Raleigh",
      "state": "NC",
      "postal_code": "27607-2994",
      "additional_info_contact": "919-459-7250",
      "reason_for_recall": "Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may fail to open following sheath retraction; and if this condition were to occur during a procedure, the result may be loss of intended integrated embolic protection.",
      "root_cause_description": "Process control",
      "action": "On 6/29/2026, recall notices started being delivered to healthcare professionals and risk managers by Medtronic sales representatives who informed of the following:\n\n1) Sales representatives will visit, conduct inventory counts, quarantine, and remove unused affected devices.\n2) If replacements are desired, they can be provided.\n3) Complete and return the acknowledgment form via email to recall@contegomedical.com\n\nQuestions can be directed to the firm at recall@contegomedical.com and 919-459-7250 Extension 4.",
      "product_quantity": "5069",
      "distribution_pattern": "US Nationwide distribution in the states of IL, FL, NC, WI, KY, AL, VA, DE, NJ, PA, IN, MI, CA.",
      "openfda": {
        "pma_number": [
          "P240009",
          "P060001",
          "P140026",
          "P040038",
          "P070012",
          "P050019",
          "P240029",
          "P050025",
          "P210030",
          "P030047",
          "P180010",
          "P040012"
        ],
        "registration_number": [
          "1643817",
          "9616099",
          "3015192261",
          "3004091615",
          "2011171",
          "3010432890",
          "2183744",
          "3002807314",
          "2939561",
          "2124215",
          "3012865735",
          "3010079067",
          "2024168",
          "3003956144",
          "3022627847",
          "3013556777",
          "1016427",
          "2024024",
          "1424778",
          "3031658894",
          "3009756327",
          "3011471056",
          "9681260",
          "2183870",
          "3010173425"
        ],
        "fei_number": [
          "1643817",
          "3002806565",
          "3015192261",
          "3004091615",
          "2011171",
          "3010432890",
          "2183744",
          "3002807314",
          "2124215",
          "3002807036",
          "3003473227",
          "3012865735",
          "3010079067",
          "2024168",
          "3003956144",
          "3022627847",
          "3013556777",
          "3003528016",
          "1016427",
          "2024024",
          "3031658894",
          "3011471056",
          "2183870",
          "3004635528",
          "3002807038"
        ],
        "device_name": "Stent, Carotid",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}