{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "218620",
      "product_res_number": "Z-1654-2026",
      "event_date_initiated": "2026-01-29",
      "event_date_posted": "2026-03-27",
      "recall_status": "Open, Classified",
      "res_event_number": "98365",
      "product_code": "QYI",
      "pma_numbers": [
        "P220023"
      ],
      "product_description": "Brand Name: Paradise Ultrasound Renal Denervation System\nProduct Name: Paradise  Catheter\nModel/Catalog Number: PRDS-068-02\nProduct Description: Common name: Ablation catheter renal denervation",
      "code_info": "Lot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4907",
      "firm_fei_number": "3010024164",
      "recalling_firm": "ReCor Medical Inc.",
      "address_1": "1049 Elwell Ct",
      "city": "Palo Alto",
      "state": "CA",
      "postal_code": "94303-4308",
      "additional_info_contact": "Lisa Luu\n650-5427700",
      "reason_for_recall": "Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On 01/28/2026, the firm informed customers verbally and sent via mail an \"MEDICAL DEVICE RECALL\" Letter that nonconforming products (cracking in the hub  adjacent to the guidewire port) that may lead to fluid leaks and could trigger a pressure error.\n\nCustomers are instructed to:\n1. Do not use the affected catheters for any patient procedures.\n2. Identify the catheters from the affected lot and return to Recor Clinical Specialist through RMA process.\n3. Review and complete the Acknowledgement and Receipt Form and provide to the Recor Clinical Specialist.\n\nFor questions or further assistance - contact Director of Regulatory & Quality Compliance  at Lisa.luu@recormedical.com or telephone at 650-542-7700",
      "product_quantity": "1",
      "distribution_pattern": "U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.",
      "openfda": {
        "pma_number": [
          "P220026",
          "P220023"
        ],
        "registration_number": [
          "3004593495",
          "9612164",
          "3010024164",
          "3002807314",
          "2953200",
          "2030624",
          "3010653929"
        ],
        "fei_number": [
          "3004593495",
          "3010024164",
          "3002806434",
          "3002807314",
          "3000206435",
          "3001452571",
          "3010653929"
        ],
        "device_name": "Ablation Catheter, Renal Denervation",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}