{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "IRVINE",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85559",
      "recalling_firm": "BIOSENSE WEBSTER",
      "address_1": "33 TECHNOLOGY DRIVE",
      "address_2": "",
      "postal_code": "92618",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI IL, VA,, NE, OK, NJ, CT, KS, HI, CO, ND, RI, ID, MS, VT, DC and WV.       \t  The countries of (EMEA, APAC, LATAM, US, Canada)  including: NZ,BE,DE,PL,SI,TR,HU,CO,KR,CL,PE,AU,BR,CA,CN,HK,ID,JP,MY,MX,PH,RU,SG,TW,TH,IL,AT,FR,GR,DE,IE,IT,PL,NL,PT,ES,SE,DK,NO,FI,CH,GB,RO,SI,HR,CZ,TR,ZA,AE,BR,ID,BE,PA,CR,CL,NZ,HK,RU,GR,NL,EG,QA,LU,NL,CH,AT,IE,CY.    See Attachments 2 & 3 for a distribution list including all domestic and foreign consignees of the device, addresses and phone numbers and the dates and number of devices distributed to each such consignee.",
      "recall_number": "Z-2371-2020",
      "product_description": "PENTARAY NAV HIGH-DENSITY MAPPING CATHETER   ELECTRODE EA 22   Rx only  STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.",
      "product_quantity": "0 units (Products were not manufactured from 2016 and later)",
      "reason_for_recall": "Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.",
      "recall_initiation_date": "20200422",
      "center_classification_date": "20200616",
      "termination_date": "20221215",
      "report_date": "20200624",
      "code_info": "This field action includes all lots of the following product codes: D-1282-07, D-1282-08, D-1282-10 and D-1282-11      The other product codes listed in the 806 report for the PENTARAY NAV High-Density Mapping Catheter: D128201, D128202, D128203, D128204, D128205, D128206 are out of scope of this recall because they were not manufactured during the period that is subject to this field action (2016 or later).     Product Code   Product Description                         GTIN Number  D-1282-01-S    PENTARAY¿ NAV, 7FR, F, 4-4-4   10846835009576  D-1282-02-S    PENTARAY¿ NAV, 7FR, F, 2-6-2   10846835009583  D-1282-03-S    PENTARAY¿ NAV, 7FR, F, 1-8-1   10846835009590  D-1282-04-S    PENTARAY¿ NAV, 7FR, D, 4-4-4   10846835009606  D-1282-05-S    PENTARAY¿ NAV, 7FR, D, 2-6-2   10846835009613  D-1282-06-S    PENTARAY¿ NAV, 7FR, D, 1-8-1   10846835009620    Note - the firm is including the above code information for products that will be distributed to new customers.  No Lot Numbers.",
      "more_code_info": ""
    }
  ]
}