{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Eden Prairie",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88408",
      "recalling_firm": "Mivi Neuroscience Inc",
      "address_1": "6545 City West Pkwy",
      "address_2": "N/A",
      "postal_code": "55344-3248",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Distribution to states of: FL, MA, NJ, NY, and TN; and  OUS (Foreign) distribution to countries of: France, Hungary, Slovenia, and Spain.",
      "recall_number": "Z-2442-2021",
      "product_description": "MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide Catheter, 90 cm, REF MIA-9090S-IDE, For Investigational Use Only.  Device is used to facilitate the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.",
      "product_quantity": "68 units",
      "reason_for_recall": "There is potential for nonsterility of product due to a possible defect in the pouch seal.",
      "recall_initiation_date": "20210723",
      "center_classification_date": "20210909",
      "termination_date": "20240523",
      "report_date": "20210915",
      "code_info": "Cat #MIA-9095S-IDE - Lots M20120006, exp. 9/10/2021; and M21030007, exp. 9/10/2021.  Cat. #MIA-9090S-IDE - Lot M21030006, exp. 12/10/2021, and M21010009, exp. 12/10/2021.",
      "more_code_info": ""
    }
  ]
}