{
  "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": "IntellaTip MiFi Open-Irrigated Ablation Catheter  Material Number: M004PM96200  Batch: 20368736 Expiration Date: 3/5/2020  Batch: 20531648 Expiration Date: 4/16/2020  Batch: 20560477 Expiration Date: 4/23/2020  Batch: 20566637 Expiration Date: 4/24/2020  Batch: 20628704 Expiration Date: 5/9/2020  Batch: 20628705 Expiration Date: 5/10/2020  Batch: 20763900 Expiration Date: 6/12/2020  Batch: 20769113 Expiration Date: 6/13/2020  Batch: 21318000 Expiration Date: 10/29/2020  Batch: 21318001 Expiration Date: 10/29/2020  Batch: 21357647 Expiration Date: 11/10/2020  Batch: 21463186 Expiration Date: 12/3/2020  Batch: 21543193 Expiration Date: 12/20/2020  Batch: 21574774 Expiration Date: 1/4/2021  Batch: 22195929 Expiration Date: 5/31/2021  Batch: 22202991 Expiration Date: 6/3/2021  Batch: 22290601 Expiration Date: 6/3/2021  Batch: 22305067 Expiration Date: 6/25/2021  Batch: 22315782 Expiration Date: 6/27/2021  Batch: 22317356 Expiration Date: 6/28/2021  Batch: 22327178 Expiration Date: 7/1/2021  Batch: 22329367 Expiration Date: 7/2/2021  Batch: 22330626 Expiration Date: 7/2/2021  Batch: 22371866 Expiration Date: 7/12/2021  Batch: 22371868 Expiration Date: 7/12/2021  Batch: 22379905 Expiration Date: 7/15/2021  Batch: 22435929 Expiration Date: 7/26/2021  Batch: 22435930 Expiration Date: 7/26/2021  Batch: 22438118 Expiration Date: 7/27/2021  Batch: 22455198 Expiration Date: 7/31/2021  Batch: 22499957 Expiration Date: 8/10/2021  Material Number: M004PM9620K20  Batch: 20371559 Expiration Date: 3/6/2020  Batch: 20542305 Expiration Date: 4/18/2020  Batch: 20548241 Expiration Date: 4/19/2020  Batch: 20639975 Expiration Date: 5/14/2020  Batch: 20677314 Expiration Date: 5/21/2020  Batch: 20772834 Expiration Date: 6/14/2020  Batch: 22321772 Expiration Date: 6/29/2021  Batch: 22326857 Expiration Date: 7/1/2021  Material Number: M004PM9620N40  Batch: 20371742 Expiration Date: 3/8/2020  Batch: 20463744 Expiration Date: 3/28/2020  Batch: 20622763 Expiration Date: 5/8/2020  Batch: 20775597 Expiration Date: 6/14/2020  Batch: 22340824 Expiration Date: 7/4/2021  Batch: 22371871 Expiration Date: 7/12/2021  Batch: 22374909 Expiration Date: 7/13/2021",
      "center_classification_date": "20190108",
      "distribution_pattern": "Japan",
      "state": "MA",
      "product_description": "IntellaTip MiFi Open-Irrigated Ablation 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-0700-2019",
      "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"
    }
  ]
}