{
  "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
    }
  },
  "results": [
    {
      "cfres_id": "41086",
      "product_res_number": "Z-0057-06",
      "event_date_initiated": "2005-08-08",
      "event_date_posted": "2005-10-15",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-05-23",
      "res_event_number": "32925",
      "product_code": "LPB",
      "pma_numbers": [
        "P030031"
      ],
      "product_description": "Thermocool Irrigated Catheters\nCelsius \nLABEL US Part Number#  EU CATALOG #\nL-1189-01-S D17TCBLRT 35Q-13R PMA; \nL-1189-02-S D17TCDLRT 35Q-33R PMA; \nL-1189-03-S D17TCFLRT  35Q-53R PMA;\nL-1189-04-S D17TCJLRT 35Q-73R PMA;\nL-1189-15-S D71TCB5L252RT 35Q-17Q EXPORT;\nL-1189-16-S D71TCD5L252RT 35Q-37Q EXPORT;\nL-1189-17-S D71TCF5L252FT 35Q-57Q EXPORT;\nL-1189-03-S D71TFL252RT 35R-53R EXPORT;\nL-1192-03-S D71TFL252RT 35R-53R EXPORT;\nL-1192-15-S D71TB5L252RT 35R-17R EXPORT;\nL-1192-16-S D7ITD5L252RT 35R-37R EXPORT;\nL-1189-02-SI D17TCDLRTI N/A IDE;\nL-1189-15-SI D71TCB5L252RTI N/A IDE;\nL-1189-16-SI D71TCD5L252RTI N/A IDE;\nL-1189-17-SI D71CF5L252RTI N/A IDE\n\nNavistar \nLABEL US Part Number#  EU CATALOG #\nL-1192-17-S D71TF5L252RT 35R-57R EXPORT;\nL-1197-14-S NI75TCBH 34H-17M PMA;\nL-1197-15-S NI75TCCH 34H-27M PMA;\nL-1197-16-S NI75TCDH 34H-37M PMA;\nL-1197-17-S NI75TCFH 34H-57M PMA;\nL-1197-18-S NI75TCJH 34H-J7M PMA;\nL-1208-05-S NS75TBCT252HS 34G-17M PMA;\nL-1208-06-S NS75TCCT252HS 34G-27M PMA;\nL-1208-07-S NS75TDCT252HS 34G-37M PMA;\nL-1208-08-S NS75TFCT252HS 34G-57M PMA;\nL-1197-14-SI NI75TCBHI N/A IDE;\nL-1197-15-SI NI75TCCHI N/A IDE;\nL-1197-16-SI NI75TCDHI N/A IDE;\nL-1197-17-SI NI75TCFHI N/A IDE;\nL-1197-18-SI NI75TCJHI N/A IDE;\nL-1208-05-SI NS75TBCT252HSI N/A IDE;\nL-1208-06-SI NS75TCCT252HSI N/A IDE;\nL-1208-07-SI NS75TDCT252HSI N/A IDE;\nL-1208-08-SI NS75TFCT252HSI N/A IDE",
      "code_info": "Lots 13027030 to 13044734",
      "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": "Mary McDermott\n909-839-8720",
      "reason_for_recall": "Increased complaints regarding catheters with leaks and flow obstruction.",
      "root_cause_description": "Other",
      "action": "Urgent letters and response forms dated August 8, 2005 directed consignees to return product.",
      "product_quantity": "9,679",
      "distribution_pattern": "FL, iL, MA, MI, OH, OK and Belguin, Netherlands, Australia, Japan, Korea, India, Sri Lanka, New Zealand,\nChina, Hong Kong, Singapore, Pakistan, Canada",
      "openfda": {
        "pma_number": [
          "P960016",
          "P990071",
          "P930029",
          "P110016",
          "P020025",
          "P050029",
          "P040036",
          "P980003",
          "P030031",
          "P990025",
          "P990054",
          "P240014",
          "P040014",
          "P020045",
          "P000020",
          "P920047",
          "P950005",
          "P060019"
        ],
        "registration_number": [
          "3013403214",
          "3003084417",
          "3001592626",
          "3015537323",
          "1000121056",
          "3019807891",
          "3007029079",
          "2030404",
          "1721686",
          "9680001",
          "9673241",
          "2029275",
          "2032098",
          "1313046",
          "3012179728",
          "1643817",
          "2032112",
          "3006891611",
          "2182208",
          "3005334138",
          "9617601",
          "3004105270",
          "2124215",
          "3008452825",
          "2184149",
          "3002648230",
          "3001763079",
          "2649622",
          "3007695959",
          "3017060084",
          "1928237",
          "1319639",
          "2028523",
          "3003923762",
          "3012552532",
          "8020893",
          "3004859241",
          "2182269",
          "3010705768",
          "3010273872",
          "2648623",
          "9681260",
          "3010280625",
          "3009243923",
          "1450662",
          "9611665",
          "3011163668",
          "3012260771",
          "1721983",
          "3008093809",
          "1650907",
          "3006634485",
          "3010653929",
          "3013300026",
          "2135338",
          "3044156918"
        ],
        "fei_number": [
          "3013403214",
          "3005700659",
          "1000138054",
          "3003084417",
          "3003076831",
          "3015537323",
          "1000121056",
          "3019807891",
          "3001592626",
          "3007029079",
          "1721686",
          "1313046",
          "3012179728",
          "1643817",
          "1000139754",
          "1000306431",
          "3006891611",
          "2182208",
          "3005334138",
          "3004105270",
          "2124215",
          "3002534070",
          "3008452825",
          "3002648230",
          "3001763079",
          "2649622",
          "3007695959",
          "3002806565",
          "3017060084",
          "1928237",
          "1000125147",
          "3003923762",
          "3012552532",
          "3002807850",
          "3004859241",
          "2182269",
          "3010705768",
          "3010273872",
          "3003248396",
          "3002808445",
          "2648623",
          "1000519796",
          "3002807095",
          "3010280625",
          "3009243923",
          "1450662",
          "3011163668",
          "3012260771",
          "3002681132",
          "3003058448",
          "1000064530",
          "3008093809",
          "3006634485",
          "3010653929",
          "3013300026",
          "3044156918"
        ],
        "device_name": "Cardiac Ablation Percutaneous Catheter",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}