{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
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  },
  "results": [
    {
      "cfres_id": "130879",
      "product_res_number": "Z-0139-2015",
      "event_date_initiated": "2014-10-19",
      "event_date_posted": "2014-10-27",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-10-06",
      "res_event_number": "69532",
      "product_code": "LPB",
      "pma_numbers": [
        "P030031",
        "P040036"
      ],
      "product_description": "ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.",
      "code_info": "Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603  All Lots manufactured from launch (Dec 2010)",
      "firm_fei_number": "3003113629",
      "recalling_firm": "Biosense Webster, Inc.",
      "address_1": "15715 Arrow Hwy",
      "city": "Irwindale",
      "state": "CA",
      "postal_code": "91706-2006",
      "additional_info_contact": "909-839-8500",
      "reason_for_recall": "The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter.",
      "root_cause_description": "Use error",
      "action": "A customer notification letter dated October 19, 2014, will be sent to all customers who purchased the Biosense Webster's ThermoCool SmartTouch Catheter Family.  The letter informs the customers of the additional information for the safe and effective use of the ThermoCool SmartTouch Catheter, which will be included in the updated labeling.  The letter informs the customers of the problems identified and the actions to be taken.  \n\nCustomers with questions related to the recall letter are instructed to contact their Biosense Webster sales representative or call (866) 473-7823, Monday through Friday from 7am to 8pm EST.",
      "product_quantity": "173,329 units total (21,812 units in US)",
      "distribution_pattern": "Nationwide Distribution",
      "openfda": {
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          "P990071",
          "P930029",
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          "P240014",
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        "fei_number": [
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        ],
        "device_name": "Cardiac Ablation Percutaneous Catheter",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}