{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Miami Lakes",
      "address_1": "14201 NW 60th Ave",
      "reason_for_recall": "Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).",
      "address_2": "",
      "product_quantity": "162 units total (74 units in USA)",
      "code_info": "Catalog Number     Lot Number       Expiry Date  4400322X               82144115          2020-04-30;  4400602S               82144141          2020-05-31;  4400515X               82144947          2020-06-30;  4400308S               82148810          2020-11-30; and   4400508S               82148811          2020-11-30.",
      "center_classification_date": "20181106",
      "distribution_pattern": "Worldwide distribution - US Nationwide in the states of AL, CA, FL, GA, IL, IN, KS, KY, LA, MA, MD, MO, MS, NC, ND, NJ, OH, PA, SC, TN, TX, and WI. Countries of Japan and Netherlands.",
      "state": "FL",
      "product_description": "Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for postdilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.",
      "report_date": "20181114",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Cordis Corporation",
      "recall_number": "Z-0390-2019",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "81294",
      "termination_date": "20210211",
      "more_code_info": "",
      "recall_initiation_date": "20180905",
      "postal_code": "33014-2802",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}