{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "93279",
      "recalling_firm": "Edwards Lifesciences, LLC",
      "address_1": "1 Edwards Way",
      "address_2": "",
      "postal_code": "92614-5688",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US: AK\tAL\tAR\tAZ\tCA\tCO\tCT\tDC\tDE\tFL\tGA\tHI\tIA\tID\tIL\tIN\tKS\tKY\tLA\tMA\tMD\tME\tMI\tMN\tMO\tMS\tMT\tNC\tND\tNE\tNH\tNJ\tNM\tNV\tNY\tOH\tOK\tOR\tPA\tPR\tRI\tSC\tSD\tTN\tTX\tUT\tVA\tWA\tWI\tWV\tWY  OUS: Argentina\tAustralia\tAustria\tBahrain\tBelgium\tBrazil\tCanada\tCANARY ISLANDS\tChile\tColombia\tCosta Rica\tCzech Republic\tDenmark\tEcuador\tFaroe Islands\tFrance\tGermany\tGreece\tGuatemala\tHong Kong\tIndonesia\tIreland\tIsrael\tItaly\tJapan\tMalaysia\tNetherlands\tNew Zealand\tNorthern Ireland\tNorway\tPanama\tPoland\tPortugal\tSaudi Arabia\tSingapore\tSlovakia\tSlovenia\tSouth Korea\tSpain\tSweden\tSwitzerland\tUnited Arab Emirates (UAE)\tUnited Kingdom\tVietnam",
      "recall_number": "Z-0410-2024",
      "product_description": "Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monitoring.",
      "product_quantity": "6,714 units",
      "reason_for_recall": "Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.",
      "recall_initiation_date": "20231004",
      "center_classification_date": "20231129",
      "report_date": "20231206",
      "code_info": "AIQS6AZ: UDI: 00690103201109/ Lot # 64891675; AIQS6AZ5: UDI: 00690103200980/ Lot # 64858220, 64858220, 64858341, 64918655, 64933575, 64939369, 64964945, 64992113",
      "more_code_info": ""
    }
  ]
}