{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "29482",
      "product_res_number": "Z-0030-04",
      "event_date_initiated": "2003-08-20",
      "event_date_posted": "2003-10-15",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-10-24",
      "res_event_number": "27231",
      "product_code": "LOX",
      "pma_numbers": [
        "P860019"
      ],
      "product_description": "Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011",
      "code_info": "Lot 5689062",
      "firm_fei_number": "3002095335",
      "recalling_firm": "Boston Scientific Scimed",
      "address_1": "One Scimed Place",
      "city": "Maple Grove",
      "state": "MN",
      "postal_code": "55311-1566",
      "additional_info_contact": "Michelle Gudith\n763-494-1194",
      "reason_for_recall": "Some of the recalled catheters have a component that has levels of pyrogens above specification.",
      "root_cause_description": "Other",
      "action": "Consignees were sent a recall letter dated August 20, 2003.  The letter requested that consignees discontinue use of the catheters from the affected lots and return them.",
      "product_quantity": "9 catheters",
      "distribution_pattern": "The recalled products were distributed to consignees located nationwide in the United States.",
      "openfda": {
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        "device_name": "Catheters, Transluminal Coronary Angioplasty, Percutaneous",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.5100",
        "device_class": "2"
      }
    }
  ]
}