{
  "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": [
    {
      "status": "Terminated",
      "city": "Temecula",
      "state": "CA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "84826",
      "recalling_firm": "Abbott Vascular",
      "address_1": "26531 Ynez Rd",
      "address_2": "D-03Q3, AP52-1",
      "postal_code": "92591-4630",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "Worldwide Distribution: US (Nation-wide) and OUS (countries of):   Algeria                      Jordan  Argentina                  Korea  Armenia                    Kuwait  Aruba                        Lebanon  Australia                    Malaysia  Austria,                      Mauritius  Bahrain                     Mexico  Bangladesh               Morocco  Belgium                     Netherlands  Brazil                         New Zealand  Brunei                        Norway  Bulgaria                      Oman  Canada                       Pakistan  Chile                            Panama  China                           Peru  Colombia                     Poland  Costa Rica                   Portugal  Croatia                          R¿union  Cyprus                          Romania  Czech Republic             Russian Federation  Denmark                       Saudi Arabia  Dominican Republic      Singapore  Egypt                             Slovakia  Estonia                          Slovenia  Finland                          South Africa  France                          Spain  Germany                       Sri Lanka  Greece                          State of Palestine  Hong Kong                    Sweden  Hungary                        Switzerland  Iceland                          Taiwan, Province of China  India                              Thailand  Indonesia                      Tunisia  Iran                               Turkey  Iraq                               Ukraine  Ireland                          United Arab Emirates  Israel                            United Kingdom  Italy                              Uruguay  Japan                           Viet Nam",
      "recall_number": "Z-1131-2020",
      "product_description": "NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00 X 20MM BDC     The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)",
      "product_quantity": "Total 39687 NC TREK units (13891 US and 25796 OUS)",
      "reason_for_recall": "Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.",
      "recall_initiation_date": "20200129",
      "center_classification_date": "20200214",
      "termination_date": "20240416",
      "report_date": "20200226",
      "code_info": "Device Identifier/GTIN: 08717648152085  Part Number: 1012453-20  Lot Numbers: 90727G1 91004G1  90830G1 91028G1  90923G1",
      "more_code_info": ""
    }
  ]
}