{
  "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 I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87254",
      "recalling_firm": "Acist Medical Systems",
      "address_1": "7905 Fuller Rd",
      "address_2": "",
      "postal_code": "55344-2137",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide - US Nationwide Distribution in the states of AL, AR, CA, CO, FL, IL, KS, KY, LA,  MD, MI, MO, NC, NJ, NY, OK, PA, RI, TN;     In the countries of  India, Italy, Japan, Poland, and United Arab Emirates.",
      "recall_number": "Z-1161-2021",
      "product_description": "ACIST Kodama Intravascular Ultrasound Catheter     The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HDi System.",
      "product_quantity": "1185 units",
      "reason_for_recall": "Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the catheter. Further testing indicated that pieces (>200 micron) of damaged o-ring had the potential to be flushed out of the catheter. ACIST is confirming the source of the failure mode to assure the quality and reliability of the Kodama catheter. There have been no related field reports related to this incident, nor any evidence or report of patient injury or adverse health consequence.",
      "recall_initiation_date": "20210122",
      "center_classification_date": "20210304",
      "termination_date": "20231030",
      "report_date": "20210310",
      "code_info": "Model Number: 017788, 018125 (Japan only); Lot codes: 00233370 (100 units), 00233371 (90 units), 00233372 (100 units), 00233373 (100 units), 00233374 (100 units), 00233380 (100 units), 00233384 (60 units), 00233385 (100 units), 00233393 (100 units), 00233394 (100 units), 00237604 (35 units), 00237613 (100 units), 03012517 (100 units)",
      "more_code_info": ""
    }
  ]
}