{
  "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": "Saint Paul",
      "state": "MN",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "89120",
      "recalling_firm": "Cardiovascular Systems Inc",
      "address_1": "1225 Old Highway 8 NW",
      "address_2": "N/A",
      "postal_code": "55112-6416",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "United States- AK, AL, AR, AZ, CA, DC, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MS, ND, NE, NH, NJ, NM, NV, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV  OUS - Netherlands",
      "recall_number": "Z-0394-2022",
      "product_description": "WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6",
      "product_quantity": "711 units",
      "reason_for_recall": "Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under such circumstances, alternative means may be necessary for withdrawal and the device may be prone to tearing or separating which may result in a risk for embolization.",
      "recall_initiation_date": "20211122",
      "center_classification_date": "20211221",
      "termination_date": "20230831",
      "report_date": "20211229",
      "code_info": "Lot Numbers:  Lot 67876, UDI 011085000049188217221221100000067876  Lot 70309, UDI 011085000049188217230110100000070309  Lot 68706, UDI 011085000049188217221227100000068706  Lot 69543, UDI 011085000049188217230103100000069543  Lot 75758, UDI 011085000049188217230203100000075758  Lot 77278, UDI 011085000049188217230210100000077278  Lot 79994, UDI 011085000049188217230223100000079994  Lot 81252, UDI 011085000049188217230301100000081252  Lot 81986, UDI 011085000049188217230307100000081986  Lot 83080, UDI 011085000049188217230313100000083080  Lot 81998, UDI 011085000049188217230320100000081998  Lot 84796, UDI 011085000049188217230327100000084796  Lot 87909, UDI 011085000049188217230411100000087909  Lot 89035, UDI 011085000049188217230418100000089035  Lot 86622, UDI 011085000049188217230404100000086622  Lot 90096, UDI 011085000049188217230424100000090096  Lot 93949, UDI 011085000049188217230515100000093949  Lot 91603, UDI 011085000049188217230501100000091603  Lot 94895, UDI 011085000049188217230521100000094895  Lot 91939, UDI 011085000049188217230507100000091939  Lot 101930, UDI 011085000049188217230717100000101930"
    }
  ]
}