{
  "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": "Mountain View",
      "address_1": "301 E Evelyn Ave",
      "reason_for_recall": "Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Balloon Guide Catheters during use for aspiration.",
      "address_2": "",
      "product_quantity": "13 units",
      "code_info": "Catalog number 90253, lot # 36140;  Catalog number 90254, lot numbers 36009, 36135.",
      "center_classification_date": "20130108",
      "distribution_pattern": "US (nationwide) including the states of CA, FL, GA, OR and TN.",
      "state": "CA",
      "product_description": "FlowGate Balloon Guide Catheter;  Manufactured by Concentric Medical, Mountain View, CA.    FlowGate" Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters with a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A balloon is flush mounted on the distal end. FlowGate" Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.",
      "report_date": "20130116",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Concentric Medical Inc",
      "recall_number": "Z-0655-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "63938",
      "termination_date": "20130205",
      "more_code_info": "",
      "recall_initiation_date": "20121220",
      "postal_code": "94041-1530",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}