{
  "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": 1
    }
  },
  "results": [
    {
      "cfres_id": "219701",
      "product_res_number": "Z-2200-2026",
      "event_date_initiated": "2026-04-06",
      "event_date_posted": "2026-05-14",
      "recall_status": "Open, Classified",
      "res_event_number": "98755",
      "product_code": "QCA",
      "pma_numbers": [
        "P170013"
      ],
      "product_description": "LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-CAS/4.5 mm x 18 mm x 14 mm, 213517-CAS/3.5 mm x 17 mm x 13 mm",
      "code_info": "Lots: 0000616462, 0000619851, 0000552987, 0000551725.\n\nUDI:\n(01)00842429115893(11)240325(17)270228(10)0000552987,\n(01)00842429115893(11)240325(17)270228(10)0000552987,\n(01)00842429115893(11)240325(17)270228(10)0000552987,\n(01)00842429115930(11)240325(17)270228(10)0000551725,\n(01)00842429115930(11)240325(17)270228(10)0000551725,\n(01)00842429115930(11)240610(17)270531(10)0000616462,\n(01)00842429115930(11)240610(17)270531(10)0000616462,\n(01)00842429115961(11)240610(17)270531(10)0000619851,\n(01)00842429115961(11)240610(17)270531(10)0000619851,\n(01)00842429115961(11)240610(17)270531(10)0000619851,\n(01)00842429115961(11)240610(17)270531(10)0000619851.",
      "firm_fei_number": "3013556777",
      "recalling_firm": "MICROVENTION INC.",
      "address_1": "35 Enterprise",
      "city": "Aliso Viejo",
      "state": "CA",
      "postal_code": "92656",
      "additional_info_contact": "714-247-8159",
      "reason_for_recall": "Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; if undersized may lead to incomplete expansion/malposition, acute stent thrombosis, distal embolization, ischemic neurological events",
      "root_cause_description": "Mixed-up of materials/components",
      "action": "On 4/6/2026, recall notices with TERUMO NEURO listed on notice top, were emailed to customers who were asked to do the following:\n1) Stop using and quarantine affected devices.\n2) Complete and return the acknowledgement form via email to \n-Distributors should provide the recall notice to medical facilities or users to whom you have distributed affected products.\n- Distributors should reconcile the completed forms from all customers and submit to recalling firm via email mvchinaqa@microvention.com\n\nIf you have questions about this recall contact firm at max.huang@microvention.com",
      "product_quantity": "38",
      "distribution_pattern": "International distribution to the country of China.",
      "openfda": {
        "device_name": "Intracranial Coil-Assist Stent",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
          "P180031",
          "P170013"
        ],
        "registration_number": [
          "3008881809",
          "3007738736",
          "3008837339",
          "3010079067",
          "3008307705",
          "3013556777",
          "3008853977"
        ],
        "fei_number": [
          "3008881809",
          "3007738736",
          "3008837339",
          "3010079067",
          "3008307705",
          "3013556777",
          "3008853977"
        ]
      }
    }
  ]
}