{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "158831",
      "product_res_number": "Z-0056-2018",
      "event_date_initiated": "2017-09-06",
      "event_date_created": "2017-10-27",
      "recall_status": "Terminated",
      "event_date_terminated": "2019-11-19",
      "res_event_number": "78129",
      "product_code": "LPB",
      "pma_numbers": [
        "P030031S053",
        "P040036S037"
      ],
      "product_description": "THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)",
      "code_info": "17445775M 17694994M 17697951M 17685286M 17697907M 17697991M 17691864M 17697910M 17697994M",
      "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": "Biosense Webster sales representative\n866-473-7823",
      "reason_for_recall": "Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a \"Map: magnetic distortion\" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy.",
      "root_cause_description": "Under Investigation by firm",
      "action": "All US and OUS customers, who have purchased the lots identified as part of this recall will be notified via customer letters in order to return the product to BWI facility where it will be segregated for further disposition. This product recall applies to hospitals (or direct customers) and distributors who have purchased and/or received the THERMOCOOL  Catheters identified as part of this recall . One notification package which includes the Customer Notification Letter, Business Reply Form (B RF) and pre-paid return label will be distributed to the customers subject to this recall via a 3rd party vendor (Stericycle) for USA. OUS\ncustomer communication will occur in accordance with local regulations.",
      "product_quantity": "64 units",
      "distribution_pattern": "US, Japan, Canada, Australia, New Zealand, Brazil, Croatia, Korea, Austria, Colombia, Italy, Portugal, Argentina, South Africa, Belgium, France, Germany, Ireland, Poland, Netherlands, Sweden, Denmark, Finland, Switzerland, Great Britain, Hungary, Czech Republic, China",
      "openfda": {
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          "P960016",
          "P240014",
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          "P060019",
          "P930029",
          "P990054",
          "P000020",
          "P980003",
          "P050029",
          "P990025",
          "P920047",
          "P990071",
          "P040014"
        ],
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        "fei_number": [
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          "3002807850",
          "3003248396",
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          "3013300026",
          "3012552532",
          "3005700659"
        ],
        "device_name": "Cardiac Ablation Percutaneous Catheter",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}