{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Plymouth",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "66597",
      "recalling_firm": "St. Jude Medical",
      "address_1": "5050 Nathan Ln N",
      "address_2": "N/A",
      "postal_code": "55442-3209",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US distribution: KS, MA, UT,TX, KY, OH.",
      "recall_number": "Z-0174-2014",
      "product_description": "US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled REF A700244, Rx only, Sterile EO.     The catheters are intended for use with a compatible external irrigation pump and the IBI-15500T9-CP RF Generator at a maximum of 50 Watts. MediGuide Enabled Ablation catheters are used with the MediGuide Technology to enable real-time tip positioning and navigation and in conjunction the the EnSite Velocity System. The MediGuide Technology is indicated for use as an adjunct to fluoroscopy.",
      "product_quantity": "59",
      "reason_for_recall": "St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batches of Coolpath Duo Ablation Catheter MediGuide Enabled products and Safire Duo Ablation Catheter MediGuide Enabled.  These units were inadvertently shipped with the incorrect version of the Instructions for Use (IFU).",
      "recall_initiation_date": "20131011",
      "center_classification_date": "20131106",
      "termination_date": "20160310",
      "report_date": "20131113",
      "code_info": "Catalog Number A700244 Batch Number 4113241.  Catalog Number A700240 Batch Number 4113242."
    }
  ]
}