{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Aliso Viejo",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "84727",
      "recalling_firm": "Microvention, Inc.",
      "address_1": "35 Enterprise",
      "address_2": "N/A",
      "postal_code": "92656-2601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "All distribution was OUS.  The countries receiving affected product are:  Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.",
      "recall_number": "Z-1403-2020",
      "product_description": "MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 180723HFRM-V, 180931HFRM-V, 181644HFRM-V, MV-80619HHFA, MV80827HHFA, MV-80931HHFA, and MV-81036HHFA.    Product Usage: The HES is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.    The firm name on the label is MicroVention, Inc., Tustin, CA.",
      "product_quantity": "32 units",
      "reason_for_recall": "The devices may be missing the implant coil.",
      "recall_initiation_date": "20191122",
      "center_classification_date": "20200227",
      "termination_date": "20220126",
      "report_date": "20200304",
      "code_info": "Catalog/lot numbers:    180723HFRM-V - 1904175P7 and 1904175W7;    180931HFRM-V - 1904225P7 and 1904225W7;    181644HFRM-V - 1905025W7 and 1905155W7;    MV-80619HHFA - 1904175X7, 1904175Y7,1905065X7, and 1905085Y7;    MV-80827HHFA - 1904175X7, 1904225Y7, and 1905065X7;    MV-80931HHFA - 1905065X7; and    MV-81036HHFA - 1904175Y7."
    }
  ]
}