{
  "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,
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  "results": [
    {
      "cfres_id": "131303",
      "product_res_number": "Z-0482-2015",
      "event_date_initiated": "2014-10-22",
      "event_date_posted": "2014-12-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-02-12",
      "res_event_number": "69669",
      "product_code": "NJE",
      "product_description": "Gateway OTW 2.75mm x 9mm;\n\nThe Gateway PTA balloon catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries for the purpose of improving intracranial perfusion.",
      "code_info": "Model M00320072209270, Lot number: 12693091;  Exp. Jun 2012.",
      "firm_fei_number": "3008853977",
      "recalling_firm": "Stryker Neurovascular",
      "address_1": "47900 Bayside Pkwy",
      "city": "Fremont",
      "state": "CA",
      "postal_code": "94538-6515",
      "additional_info_contact": "Gary Rebman\n510-413-2263",
      "reason_for_recall": "Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.",
      "root_cause_description": "Process control",
      "action": "Stryker Neurovascular sent an Urgent Medical Device Recall Notification dated October 22, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.\n\nLetters request that users take the following actions:\n1.   Immediately locate the subject devices and quarantine them.\n2.   Distribute this notice to all affected Departments in your facility.\n3.   Inform Stryker Neurovascular if any of the subject devices have been distributed to other organizations.\na.   Please provide contact details so that Stryker Neurovascular can inform those recipients appropriately.\n4.   Complete and sign the attached Customer Response Form and:\na.   Fax it to: 1-866-876-4355  or\nb.   E-mail a copy to:  NeuroComplaints@stryker.com\nc.   Please complete this form even if you do not have any subject devices to return to prevent the need of follow up notices.\n5.   Keep a copy of the completed, signed Customer Response Form for your\nrecords.\n\nStryker Customer Service reps will contact customers to arrange for replacement.\nAny returned product will be quarantined and destroyed.",
      "product_quantity": "1 unit",
      "distribution_pattern": "US Distribution to the states of: VA, NH, OH and TX.",
      "openfda": {
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          "3002807314",
          "9681260",
          "1721676",
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          "3008837339",
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        ],
        "device_name": "Intracranial Neurovascular Stent",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "f"
      }
    }
  ]
}