{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "142033",
      "product_res_number": "Z-0465-2016",
      "event_date_initiated": "2015-11-20",
      "event_date_created": "2015-12-22",
      "recall_status": "Terminated",
      "event_date_terminated": "2019-11-27",
      "res_event_number": "72721",
      "product_code": "OAD",
      "pma_numbers": [
        "P020025S036"
      ],
      "product_description": "IntellaTip MiFi XP Asymmetric (N4) Curve\n7/110/2.5/8-10 ;\nMaterial Number: M004PM4790N40; Catalog number: PM4790N4;\n\nCardiac:  \nThe 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.",
      "code_info": "Material Number: M004PM4790N40;  Catalog number: PM4790N4; Lot numbers: 16743269, 16818653, 16818654, 16872007, 16993525, 17511087, 18159904, 18385792. Expiration Date Range: 9/1/2016 to 9/20/2018. .",
      "firm_fei_number": "3001236349",
      "recalling_firm": "Boston Scientific Corp",
      "address_1": "150 Baytech Dr",
      "city": "San Jose",
      "state": "CA",
      "postal_code": "95134-2302",
      "additional_info_contact": "Nicole Pshon\n763-494-7971",
      "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 BSC's product risk documentation.",
      "root_cause_description": "Device Design",
      "action": "Boston Scientific sent an Urgent Medical Device Removal letters to all affected customers dated November 20, 2015 via Fed Ex or other equivalent service.  The letter identified the affected products, problem and actions to be taken.  Customers were instructed to contact their local Sales Representative to answer any questions.",
      "product_quantity": "1556 total - all models",
      "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.",
      "openfda": {
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          "P040042",
          "P110016",
          "P020025",
          "P050024",
          "P030031",
          "P010068",
          "P950005",
          "P060019"
        ],
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          "3008093809",
          "3012520654",
          "3006634485",
          "3010653929",
          "3011120183",
          "3013300026"
        ],
        "device_name": "Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}