{
  "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": [
    {
      "country": "United States",
      "city": "Temecula",
      "address_1": "26531 Ynez Rd",
      "reason_for_recall": "Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.",
      "address_2": "",
      "product_quantity": "449,661 units total (132,040 units in US)",
      "code_info": "Lot Number  60202G1  60301G1  60502G1  60301G1  60401G1  61101G1  60202G1  60401G1  60601G1  60801G1  61101G1  60302G1  60401G1  60601G1  60801G1  60202G1  60401G1  60502G1  60601G1  60701G1  60902G1  61004G1  61101G1  60202G1  60301G1  60401G1  60502G1  60601G1  60701G1  60801G1  60902G1  61101G1  60401G1  60601G1  60801G1  60301G1  60701G1  60301G1  60502G1  60701G1  60301G1  60502G1  60701G1  60902G1  60301G1  60502G1  60701G1  61004G1  60301G1  60401G1  60601G1  60701G1  60805G1  61004G1  50204G1  50406G1  50202G1  50901G1  50204G1  60202G1  60502G1  60701G1  61101G1  60202G1  60506G1",
      "center_classification_date": "20170512",
      "distribution_pattern": "US and Worldwide",
      "state": "CA",
      "product_description": "NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T,  1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T,  1012449-15T, 1012450-08T, 1012450-12T, 1012450-15T,  1012451-08T, 1012451-12T, 1012451-15T, 1012452-08T,  1012452-12T, 1012452-15T, 1012453-08T, 1012453-12T",
      "report_date": "20170524",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Abbott Vascular",
      "recall_number": "Z-2039-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "76841",
      "termination_date": "20180207",
      "more_code_info": "",
      "recall_initiation_date": "20170322",
      "postal_code": "92591-4630",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}