{
  "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": "2026-08-13",
    "results": {
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    {
      "cfres_id": "203600",
      "product_res_number": "Z-0238-2024",
      "event_date_initiated": "2023-09-07",
      "event_date_posted": "2023-11-06",
      "recall_status": "Open, Classified",
      "res_event_number": "93172",
      "product_code": "DXE",
      "k_numbers": [
        "K892410"
      ],
      "product_description": "Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35",
      "code_info": "UDI-DI: 00690103043532, Lot: 64936927",
      "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": "Linnette Torres\n949-756-4582",
      "reason_for_recall": "Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On 9/7/23, correction notices were sent to customers informing them to take the following actions: \n2) Return affected devices.\n3) Forward notice to any of your customers who have purchased the impacted devices.\n3) Complete and return the acknowledgement form.",
      "product_quantity": "185",
      "distribution_pattern": "OUS: Singapore, Taiwan, Canada",
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        "device_name": "Catheter, Embolectomy",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.5150",
        "device_class": "2"
      }
    }
  ]
}