{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "158735",
      "product_res_number": "Z-0054-2018",
      "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": [
        "P030031S072"
      ],
      "product_description": "THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S",
      "code_info": "17682851L 17682730L 17685880L 17685740L 17685692L 17680131L 1768581 lL 17685897L 17685789L 17676998L 17685889L 17685896L 17685792L 17685741L 17685758L 17685846L 17689428L 17689420L 17685881L 17680081L 17689454L 17682788L 17685853L 17685750L 17692068L 17689430L 17680080L 17682787L 17692069L 17689463L 17689421L 17685691L",
      "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": "357 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",
          "P020045",
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          "P990071",
          "P040014",
          "P950005",
          "P000020",
          "P030031",
          "P990025",
          "P060019",
          "P050029",
          "P110016",
          "P990054",
          "P920047"
        ],
        "registration_number": [
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        ],
        "fei_number": [
          "1000519796",
          "3017060084",
          "3002534070",
          "3012179728",
          "1000138054",
          "3003076831",
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          "3012552532",
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        ],
        "device_name": "Cardiac Ablation Percutaneous Catheter",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}