{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "80199",
      "product_res_number": "Z-0899-2011",
      "event_date_initiated": "2009-02-27",
      "event_date_posted": "2011-01-12",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-01-13",
      "res_event_number": "51401",
      "product_code": "GBS",
      "k_numbers": [
        "K021899"
      ],
      "product_description": "Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF 90072, manufactured by Concentric Medical, Inc., Mountain View, CA\nProduct is 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. Not intended for use to deliver embolic agents or to perform angioplasty.",
      "code_info": "Lot numbers 33367 and 33407",
      "firm_fei_number": "3003271051",
      "recalling_firm": "Concentric Medical Inc",
      "address_1": "301 E Evelyn Ave",
      "city": "Mountain View",
      "state": "CA",
      "postal_code": "94041-1530",
      "additional_info_contact": "650-810-1716 Ext. 1707",
      "reason_for_recall": "Product malfunction-- hub may leak at connection to the shaft due to insufficient adhesive curing.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Concentric Medical products sent an URGENT VOLUNTARY MEDICAL DEVICE REMOVAL letter to all affected customers.  The letter identified the product, the problem, and the action to be taken by the customer.\nCustomers were instructed to examine their inventory and identify any affected product.\nQuarantine the product and call Concentric Medical Customer Service at 877-471-0076 (USA toll-free) or 650-938-2100 to receive instructions for returning the devices.\nFor questions regarding this recall call 877-471-0076.",
      "product_quantity": "36 units affected.",
      "distribution_pattern": "Worldwide Distribution - USA including AL, FL, GA, IL, MN, NY, OH, OR, PA, TX, VA, WA, and WV and one consignee in Turkey and one in Switzerland",
      "openfda": {
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          "K862584",
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          "K810158",
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          "K872457",
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          "K813587",
          "K863247",
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          "3003256355",
          "1000237915",
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        ],
        "device_name": "Catheter, Ventricular, General & Plastic Surgery",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4200",
        "device_class": "1"
      }
    }
  ]
}