{
  "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-2441-2021",
      "product_description": "MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and MIA-9095S (95 cm length), MIA-9080-E, MIA-9090S-E, MIA-9095S-E, Sterile.  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": "491 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 - Lots M20090013, exp. 9/10/2021; and M20110008, 10/26/2021.  Cat. #MIA-9095S-E - Lots M20090012, exp. 9/10/2021; M20110007, exp. 10/26/2021; M21030017, exp. 10/26/2023; M21030018, exp. 9/10/2023; M21040003, exp. 4/24/2024; M21050014, exp. 1/27/2023; M21050015, exp. 1/27/2023; M21060002, exp. 2/7/2023; and M21060003, exp. 3/12/2023.  Cat. #MIA-9090S - Lot M20110006, exp. 10/27/2021.  Cat. #MIA-9090S-E - Lots M20080005, exp.8/6/2021; M20090011, exp. 9/10/2021; M20110005, exp. 10/27/2021;  M21010008, exp. 12/10/2021; M21030014, exp.12/10/2023; M21030015, exp. 12/10/2023;  M21050013, exp. 12/10/2023;  M21060006, exp. 4/3/2022; M21060007, exp. 10/30/2022; M21060008, exp. 10/30/2022; M21060009, exp. 1/27/2023; M21060010, exp. 1/27/2023; M21060011, exp. 3/12/2023; and M21060012, exp. 12/10/2023.     Cat. #MIA9080S - Lot M20110009, exp. 10/27/2021.  Cat. #MIA 9080S-E - Lots M21010011, exp. 12/10/2021; M21030005, exp. 10/27/2023; M21030013, exp. 4/30/2023; M21060014, exp. 10/10/2022; M21060015, exp. 10/22/2022; M21060016, exp. 4/30/2023; and M21060017, exp. 12/10/2023.",
      "more_code_info": ""
    }
  ]
}