{
  "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": "196312",
      "product_res_number": "Z-0170-2023",
      "event_date_initiated": "2022-09-21",
      "event_date_posted": "2022-11-02",
      "recall_status": "Open, Classified",
      "res_event_number": "90966",
      "product_code": "OPR",
      "pma_numbers": [
        "P170032"
      ],
      "product_description": "WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2.  Component of WEB Aneurysm Embolization System.",
      "code_info": "REF/UDI/Lots: WDC-2/00842429103128/0000095683, 0000096284, 0000205967, 0000206629, 0000215962, 0000216862, 0000224074, 0000241662, 0000242343, 0000242345;\n\nDistributed in China: WDC/00842429113684/0000078840, 0000086571, 0000088347, 0000088349, 0000136477, 0000181460, 0000191147;\n\n\nDistribution in Japan: MV-WDC2/04987892122231/0000142172; 0000166445; 0000210109; 0000245337",
      "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": "Detachment controller, of an aneurysm embolization system, has an out of specification tunnel opening dimension, which may prevent the implant device pusher from being fully inserted into the controller, which may result in the inability of the controller to properly detach the implant device, which could cause delays and excessive manipulation that may cause the implant to move and damage vessels",
      "root_cause_description": "Process control",
      "action": "On 09/21/2022, recall notices were mailed to customers who were asked to do the following:\n\n1) Identify, quarantine, and return all impacted devices.\n2) Complete and return Customer Acknowledgment and Device Reconciliation form \n\n the recall instructions provided in the letter and have shared this notification with all device users within my facility and network to ensure they are aware of this recall. This recall notice should also be shared with any organization where the potentially affected devices have been transferred.  \n\nComplete and return the acknowledgement and receipt form.\n\nCustomers with additional questions can call the recalling firm at 949-501-0355, Monday - Friday PST 8:00 - 5:00 pm or email customerservice@microvention.com",
      "product_quantity": "2018",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of MN, PA, NY, MI, FL, VA, TX, OH, CA, NE, MN, NC, LA, IL, TN, IN, UT, KS and the countries of Japan, China, Argentina, Australia, South Korea, Italy, UK.",
      "openfda": {
        "device_name": "Intrasaccular Flow Disruption Device",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
          "P170032"
        ],
        "registration_number": [
          "1037998",
          "3013556777",
          "2029214",
          "3022418643",
          "3013408612",
          "3008307705",
          "2011171"
        ],
        "fei_number": [
          "1037998",
          "3013556777",
          "1000220862",
          "3022418643",
          "3013408612",
          "3008307705",
          "2011171"
        ]
      }
    }
  ]
}