{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "San Jose",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "72721",
      "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": "Worldwide Distribution - US Nationwide in the state of: PA, FL, IN, MI, TN, AL, IL, KY, MI, TX, OH, MO, MA, MN, ID, AL, TN, VA, CA and internationally to Austria, Australia, Belgium, Switzerland, Germany, Great Britain, Greece, Hong Kong, Israel, Iran, Italy, Japan, Kuwait, Latvia, Malaysia, Netherlands, Saudi Arabia, Singapore, Thailand, and South Africa.",
      "recall_number": "Z-0463-2016",
      "product_description": "IntellaTip MiFi XP Asymmetric (N4) Curve  7/110/2.5/8-10 OUS;  Material Number: M004EPM4790N40; Catalog number: EPM4790N4;    Cardiac:    The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia  typically chronic, drug refractory atrial fibrillation.",
      "product_quantity": "1556 total - all models",
      "reason_for_recall": "During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BSCs product risk documentation.",
      "recall_initiation_date": "20151120",
      "center_classification_date": "20151222",
      "termination_date": "20191127",
      "report_date": "20151230",
      "code_info": "Material Number: M004EPM4790N40;   Catalog number: EPM4790N4;  Lot numbers: 16743398, 17135082..  Expiration Date Range: 2/16/2017 to 7/22/2017"
    }
  ]
}