{
  "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": "2026-10-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "cfres_id": "222212",
      "product_res_number": "Z-0134-2027",
      "event_date_initiated": "2026-07-31",
      "event_date_posted": "2026-10-09",
      "recall_status": "Open, Classified",
      "res_event_number": "99697",
      "product_code": "NPT",
      "pma_numbers": [
        "P250024"
      ],
      "product_description": "JenaValve Trilogy Delivery Catheter, Size 23MM\r\nREF: TRILOGY-DC-S",
      "code_info": "GTIN - 00850000898134/ Lot: DS-040826-003\nDS-042326-003,\nDS-042726-006,\nDS-042826-005,\nDS-050426-007,\nDS-050626-002,\nDS-050626-006,\nDS-050626-009,\nDS-050726-005",
      "firm_fei_number": "3012148004",
      "recalling_firm": "Jenavalve Technology Inc.",
      "address_1": "4 Cromwell",
      "city": "Irvine",
      "state": "CA",
      "postal_code": "92618-1816",
      "additional_info_contact": "John Kilcoyne\n+1-949-767-2110 Ext. 1030",
      "reason_for_recall": "Delivery Catheter may  have sleeve liner separation that results in difficulty or inability  to  deploy heart valve device.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On the dates of August 1, 4, 6,  and 19th, JenaValve Technology Inc. issued a Urgent: Medical Device Recall notification via email.  JenaValve asked consignees to take the following actions: \n\n1.\tReview the information contained in this letter and ensure that anyone in your facility who needs to be aware of this notification reads this letter carefully.\n2.\tExamine your inventory immediately to determine if you have Trilogy Delivery Catheters from the affected lots and quarantine the subject products. \n3.\tJenaValve field team members will schedule a visit to retrieve the subject Trilogy Delivery Catheters. If you prefer to return the products yourself, please contact us at 866-588-8287 and we will provide you with an RGA number prior to you shipping them to:\nJenaValve Technology Inc., 4 Cromwell, Irvine, California 92618, USA; Attn: Quality Department; Reference: FA26001\n4.\tPlease complete and sign the Business reply form (BRF) of this letter and email it to customersupport.us@jenavalve.com or give it to your JenaValve field representative.\n5.\tUpon receipt of the completed BRF and returned product, JenaValve will provide replacement products. Incomplete BRFs cannot be processed.\n6.\tIf any of the subject Trilogy Delivery Catheters have been transferred to another facility, identify the receiving facility on the Business Reply Form, contact customersupport.us@jenavalve.com, and provide a copy of this letter to the relevant personnel.",
      "product_quantity": "111 units",
      "distribution_pattern": "US Nationwide distribution in the states of AZ, CA, FL, GA, IL, MA,  MD, MI, MN, MO, NY, OH, PA, SC, TX, UT, VA, WA and the countries of Germany, Denmark, Great Britain, Italy.",
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          "P100041",
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          "P140031",
          "P130009"
        ],
        "device_name": "Aortic Valve, Prosthesis, Percutaneously Delivered",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
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