{
  "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  60414G1  60721G1  60208G1  60419G1  60420G1  60603G1  60906G1  61121G1  61121G2  60225G1  60229G1  60318G1  60318G2  60429G1  60429G2  60607G1  60705G1  60804G1  60818G1  60921G1  60921G2  61108G1  61111G1  61128G1  61128G2  61218G1  60202G1  60310G1  60401G1  60408G1  60408G2  60510G1  60616G1  60721G1  60809G1  60912G1  61014G1  61028G1  61206G1  61206G2  60310G1  60421G1  60421G2  60527G1  60716G1  60819G1  61024G2  60523G1  61026G1  60317G1  60318G1  60412G1  60419G1  60502G1  60502G2  60525G1  60705G1  60801G1  60809G1  60826G1  60916G1  61018G1  61121G1  61121G2  60218G1  60303G1  60330G1  60330G2  60406G1  60406G2  60406G3  60406G4  60408G1  60413G1  60413G2  60425G1  60429G1  60511G1  60512G1  60531G1  60607G1  60623G1  60713G1  60721G1  60804G1  60805G1  60809G1  60812G1  60816G1  60824G1  60926G1  60929G1  61012G1  61019G1  61019G2  61020G1  61115G1  61121G1  61122G1  61123G1  61123G2  61201G1  61208G1  61214G1  61214G2  61216G1  61216G2  60128G1  60215G1  60215G2  60224G1  60322G1  60329G1  60330G1  60330G2  60330G3  60401G1  60407G1  60407G2  60427G1  60428G1  60428G2  60428G3  60429G1  60502G1  60603G1  60609G1  60621G1  60718G1  60720G1  60727G1  60801G1  60809G1  60810G1  60816G1  60824G1  60906G1  60919G1  60926G1  60928G1  61104G1  61107G1  61111G1  61111G3  61122G1  61123G1  61128G1  61130G1  61202G1  60126G1  60223G1  60225G1  60226G1  60323G1  60331G1  60331G2  60516G1  60519G1  60721G1  60805G1  60824G1  60907G1  61004G1  61116G1  61128G1  61130G1  61206G1  60405G1  60412G1  60805G1  60610G1  61101G1  60530G1  60803G1  61014G1  61206G1  60212G1  60412G1  60414G1  60528G1  60623G1  60831G1  60921G1  61104G1  61207G1  61209G1  60315G1  60317G1  60328G1  60414G1  60414G2  60613G1  60718G1  60810G1  60901G1  60922G1  61128G1  61130G1  60318G1  60329G1  60429G1  60613G1  60804G1  60929G1  60603G1  61006G1  60323G1  60329G1  60329G2  60330G1  60425G1  60428G1  60526G1  60531G1  60623G1  60713G1  60805G1  60819G1  60929G1  61104G1  61204G1  61206G1  61207G1  61208G1  60205G1  60214G1  60215G1  60322G1  60330G1  60408G1  60415G2  60415G3  60415G4  60418G1  60418G2  60502G1  60525G2  60527G1  60527G2  60601G1  60616G1  60629G1  60720G1  60729G1  60805G1  60818G1  60829G1  60907G1  60922G1  61003G1  61010G1  61107G1  61108G1  61114G1  61122G1  61123G1  61130G1  61212G1  61212G2  61213G1  60210G1  60224G1  60226G1  60227G1  60229G1  60307G1  60314G1  60329G1  60329G2  60331G1  60401G1  60408G1  60408G2  60505G1  60512G1  60603G1  60607G1  60628G1  60701G1  60720G1  60727G1  60801G1  60818G1  60826G1  60826G2  60909G1  60909G2  60913G1  60920G1  61010G1  61024G1  61101G1  61115G1  61118G1  61123G1  61123G2  61202G1  61204G1  61214G1  60128G1  60307G1  60310G1  60318G1  60329G1  60419G1  60419G2  60519G1  60603G1  60824G1  60830G1  60901G1  60927G1  61115G1  61121G1  61201G1  60809G1  50114G1  50316G1  50319G1  50513G1  51022G1  51217G1  60112G1  60603G1  60810G1  60921G1  61007G1  61216G1  50109G1  50210G1  50306G1  50317G1  50330G1  50420G1  50817G1  50928G1  51023G1  51029G1  60217G1  60226G1  60308G1  60311G1  60712G1  60909G1  61102G1  61122G1  50105G1  50115G1  50213G1  50316G1  50319G1  50420G1  50609G1  50929G1  51103G1  51109G1  60224G1  60331G1  60405G1  60505G1  60718G1  60726G1  60826G1  61115G1  61128G1  61208G1  50106G1  50120G1  50204G1  50206G1  50316G1  50603G1  51110G1  60412G1  60607G1  61018G1  60405G1  60413G1  60413G2  60425G1  60425G2  60621G1  60720G1  60729G1  60819G1  61026G1  61130G1  61204G1  60302G1  60408G1  60415G1  60502G1  60502G2  60503G1  60503G2  60621G1  60705G1  60722G1  60810G1  60907G1  61004G1  61012G1  61214G1  61218G1  60301G1  60303G1  60329G1  60331G1  60427G1  60428G1  60613G1  60617G1  60721G1  60819G1  60822G1  60909G1  61026G1  61111G1  61121G1  60209G1  60226G1  60505G1  60623G1  60810G1  60926G1  61122G1",
      "center_classification_date": "20170512",
      "distribution_pattern": "US and Worldwide",
      "state": "CA",
      "product_description": "NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12, 1012448-15, 1012448-20, 1012449-06, 1012449-08, 1012449-12, 1012449-15, 1012449-20, 1012449-25, 1012450-06, 1012450-08, 1012450-12, 1012450-15, 1012450-20, 1012451-06, 1012451-08, 1012451-12, 1012451-15, 1012451-20, 1012451-25, 1012452-08, 1012452-12, 1012452-15, 1012452-20, 1012453-08, 1012453-12, 1012453-15, 1012453-20",
      "report_date": "20170524",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Abbott Vascular",
      "recall_number": "Z-2037-2017",
      "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"
    }
  ]
}