{
  "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": [
    {
      "country": "United States",
      "city": "Marlborough",
      "address_1": "300 Boston Scientific Way",
      "reason_for_recall": "Supplier had changed its resin sub-suppliers three (3) times without notifying BSC.  These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation.  Not approved in customer document.",
      "address_2": "",
      "product_quantity": "1,282 (all three types in Japan)",
      "code_info": "Blazer Open Irrigated Ablation Catheter  Material Number: M00496200,  Batch: 20399570, Expiration Date: 3/13/2020  Batch: 21778776, Expiration Date: 2/21/2021  Batch: 22152470, Expiration Date: 5/21/2021  Batch: 22499259, Expiration Date: 8/13/2001  Material Number: M0049620N40  Batch::20413170, Expiration Date: 3/16/2020  Batch: 20809676, Expiration Date: 6/22/2020   Material Number: M0049620K20   Batch: 20403945, Expiration Date: 3/13/2020",
      "center_classification_date": "20190108",
      "distribution_pattern": "Japan",
      "state": "MA",
      "product_description": "Blazer Open-Irrigated Ablation Batch Catheter      Product Usage:  Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for:   Cardiac electrophysiological mapping   Delivering diagnostic pacing stimuli   RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older   Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system",
      "report_date": "20190116",
      "classification": "Class III",
      "openfda": {},
      "recalling_firm": "Boston Scientific Corporation",
      "recall_number": "Z-0699-2019",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "81747",
      "more_code_info": "",
      "recall_initiation_date": "20181128",
      "postal_code": "01752-1291",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Ongoing"
    }
  ]
}