{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "96170",
      "recalling_firm": "Biosense Webster, Inc.",
      "address_1": "31 Technology Dr Ste 200",
      "address_2": "",
      "postal_code": "92618-2302",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Worldwide distribution; US states of AR, CA, CO, KS, LA, MA, MO, NY, OH and TX.   EMEA, New Zealand, Saudi Arabia, Oman, United Ecuador, Panama, South Africa, China  Austria Belgium Czech Republic France Germany Hungary Ireland  Israel Italy UK Sweden Norway Denmark Finland Luxembourg Netherlands Poland Portugal Slovenia Spain Switzerland Serbia United Arab Emirates Croatia Canada South Korea Japan",
      "recall_number": "Z-1205-2025",
      "product_description": "VARIPULSE Bi-Directional Ablation Catheter  REF D141201.      The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used for TRUPULSE Generator, for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. The catheter provides location information when used with the CARTO 3 System.",
      "product_quantity": "497 total catheter - 378 US and 119 OUS",
      "reason_for_recall": "Due to an observed trend of neurovascular events",
      "recall_initiation_date": "20250105",
      "center_classification_date": "20250228",
      "report_date": "20250312",
      "code_info": "Product Number: D141201-12 UDI-DI code: 10846835025460 Batch Numbers: 31483574L 31483560L 31483581L 31483542L 31487313L 31483552L 31483544L 31487311L 31483550L 31483558L 31483575L 31483556L 31487312L 31483553L 31483565L 31483576L 31483547L 31487320L 31483549L 31483561L 31483548L 31483564L 31483541L 31483546L 31483562L 31483566L 31483583L 31483567L",
      "more_code_info": ""
    }
  ]
}