{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "219274",
      "product_res_number": "Z-2172-2026",
      "event_date_initiated": "2026-03-27",
      "event_date_posted": "2026-05-13",
      "recall_status": "Open, Classified",
      "res_event_number": "98633",
      "product_code": "NPW",
      "pma_numbers": [
        "P230013"
      ],
      "product_description": "Edwards EVOQUE tricuspid delivery system\nREF:9850TDS\nSterile EO",
      "code_info": "All Lots/UDI:0690103D004EVD000V5",
      "firm_fei_number": "2015691",
      "recalling_firm": "Edwards Lifesciences, LLC",
      "address_1": "1 Edwards Way",
      "city": "Irvine",
      "state": "CA",
      "postal_code": "92614-5688",
      "additional_info_contact": "Brian Hudson\n949-250-6827",
      "reason_for_recall": "Labeling update to provide warning if functionality of the  valve replacement delivery system is compromised.",
      "root_cause_description": "Labeling design",
      "action": "On March 27, 2025, Edwards Lifesciences issued a Urgent: Medical Device Recall (Correction) Notification via mail. Edwards ask consignees to take the following actions: \n\n1. There is no need to return any product and no patient follow-up or notification is necessary.\n\n2. Please review this Urgent: Medical Device Recall (Correction) Notice .\n\n3. Return the completed Customer Acknowledgment Form to your Edwards TMTT Representative or via email to xxxx@edwards.com. Electronic signatures may also be used, where available, to facilitate physician acknowledgment.",
      "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Saudi Arabia, Germany, United Kingdom.",
      "openfda": {
        "device_name": "Percutaneously Delivered Prostheses And Tricuspid Valves",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
          "P230013"
        ],
        "registration_number": [
          "3007063218",
          "2015691",
          "3008500478",
          "1721676",
          "2011171"
        ],
        "fei_number": [
          "3007063218",
          "2015691",
          "1713910",
          "1721676",
          "2011171"
        ]
      }
    }
  ]
}