{
  "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": "159886",
      "product_res_number": "Z-0212-2018",
      "event_date_initiated": "2017-05-17",
      "event_date_created": "2017-12-07",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-12-15",
      "res_event_number": "77529",
      "product_code": "MTD",
      "k_numbers": [
        "K120425",
        "K123837"
      ],
      "product_description": "PENTARAY NAV High-Density Mapping Catheter.",
      "code_info": "Product code (Product Description) (GTIN): D-1282-07-S (NAV ECO 7FR, F, 4-4-4) (10846835012217), D-1282-08-S (NAV ECO 7FR, F, 2-6-2) (10846835012224), D-1282-09-S (NAV ECO 7FR, F, 1-8-1) (10846835012231), D-1282-10-S (NAV ECO 7FR, D, 4-4-4) (10846835012248), D-1282-11-S (NAV ECO 7FR, D, 2-6-2) (10846835012255), D-1282-12-S (NAV ECO 7FR, D, 1-8-1) (1846835012262).",
      "firm_fei_number": "3003113629",
      "recalling_firm": "Biosense Webster, Inc.",
      "address_1": "15715 Arrow Hwy",
      "city": "Irwindale",
      "state": "CA",
      "postal_code": "91706-2006",
      "reason_for_recall": "Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.",
      "root_cause_description": "Other",
      "action": "Recall Notification letter, dated 04/14/2016, and Acknowledgement Form was sent to customers via express mail on 05/17/2017.  Instructions included to read and follow Labeling Correction Notice carefully, provide the notice to anyone in the facility that should be aware, sign and return the Acknowledgement Form, and to maintain awareness of the correction.",
      "product_quantity": "73,796 units total",
      "distribution_pattern": "Nationwide \n\nDistributed internationally to Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Republic of Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, The Netherlands, New Zealand, Norway, Oman, People's Republic of China, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.",
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          "K153093",
          "K140733",
          "K241372",
          "K120425",
          "K003782",
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        "registration_number": [
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        "device_name": "Catheter, Intracardiac Mapping, High-Density Array",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1220",
        "device_class": "2"
      }
    }
  ]
}