{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "San Jose",
      "state": "CA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "70506",
      "recalling_firm": "Boston Scientific Corp",
      "address_1": "150 Baytech Dr",
      "address_2": "N/A",
      "postal_code": "95134-2302",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed in Germany, Great Britain, and the  Netherlands.",
      "recall_number": "Z-1209-2015",
      "product_description": "IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters:  Material number: M004EPM96200, Catalog Number: EPM9620:  Material number: M004EPM9620K20, Catalog Number: EPM9620K2;  Material number : M004EPM9620N40; Catalog number: EPM9620N4.        The IntellaTip MiFi Open-Irrigated Ablation Catheter is a 7.5F (2.5 mm) quadrapolar open-irrigated (OI) ablation catheter designed to deliver radiofrequency (RF) energy to the 4.5 mm catheter tip electrode for cardiac ablation    The product is not approved for use/sale in the US.",
      "product_quantity": "14 units",
      "reason_for_recall": "Reports of formation of char adherent to the proximal part of the distal tip electrodes",
      "recall_initiation_date": "20150203",
      "center_classification_date": "20150302",
      "termination_date": "20170321",
      "report_date": "20150311",
      "code_info": "Material number: M004EPM96200, Catalog Number EPM9620;  Serial numbers: 16941576, 16943730, 17150129, 17156568, 17156570, 17168752, 17171230, 17218387, 17221754, 17237747, 17247469, 17261879.    Material number: M004EPM9620K20, Catalog Number: EPM9620K2:  Serial numbers : 17018928, 17018929, 17147617, 17172602, 17175351, 17223957, 17230227, 17233882, 17235011, 17241926, 17263604, 17285884, 17288714.    Material number : M004EPM9620N40; Catalog number: EPM9620N4;  Serial numbers: 17148152, 17226126, 17266642.    All with Expiry Dates of April 20, 2015 - June 14, 2015."
    }
  ]
}