{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "72661",
      "product_res_number": "Z-0110-2009",
      "event_date_initiated": "2008-05-20",
      "event_date_posted": "2008-10-14",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-12-10",
      "res_event_number": "49061",
      "product_code": "NTE",
      "k_numbers": [
        "K063313"
      ],
      "product_description": "Boston Scientific FilterWire EZ\" Embolic Protection System, Model FW EZ 300cm, 3.5-5.5 mm, MT OUS PV, Material H749201053000, Model # 20105-300, Sterilized with irradiation, Made in USA: 2011 Stierlin Court, Mountain View, CA 94043-4655.  Filter wire EZ\" Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts and carotid arteries. The diameter of the vessel at the site of filter loop placement should be between 2.25 mm and 5.5 mm for coronary saphenous vein bypass graft procedures and between 3.5 mm and 5.5 mm for carotid procedures.",
      "code_info": "731004, 731803, and 805701",
      "firm_fei_number": "3002095335",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "1 Scimed Pl",
      "city": "Maple Grove",
      "state": "MN",
      "postal_code": "55311-1565",
      "additional_info_contact": "800-272-3737",
      "reason_for_recall": "Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ\" Embolic Protection System.  Boston Scientific has determined that the Directions for Use (DFU), which accompanies each packaged device, may be missing.  If the product does not include a DFU and the user is unable to find a copy, the user will have to seek another product box containing the DFU.  This may",
      "root_cause_description": "Employee error",
      "action": "Consignees were sent a \"Boston Scientific Urgent Medical Device Recall or Correction-Immediate Action Required\" letter dated May 20, 2008. The letter addressed to Risk Mangers, described the issue and product. A Reply Verification Tracking Form was requested to be completed and returned.  Contact Boston Scientific Corporation at 1-800-272-3737 for assistance.",
      "product_quantity": "A total of 4338 units distributed.",
      "distribution_pattern": "US: AL AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD. TN,  TX. UT, VA, VT, WV, WA, WI, WY, and PR.\n\nEuropean Countries: Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Great Britain, Germany, Greece, Hungary, Italy, Latvia, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Spain, Sweden, and Switzerland, \n\nIntercontinental: Taiwan, Korea, Australia, China, Singapore, Canada, Columbia, and Mexico.",
      "openfda": {
        "k_number": [
          "K092177",
          "K101651",
          "K083300",
          "K052454",
          "K052165",
          "K210282",
          "K052166",
          "K121015",
          "K110909",
          "K042908",
          "K042218",
          "K123156",
          "K143072",
          "K200198",
          "K230402",
          "K063313",
          "K052659",
          "K222694",
          "K090665",
          "K180023",
          "K081549",
          "K141678",
          "K062531",
          "K072990",
          "K220654",
          "K153485",
          "K191173",
          "K063204",
          "K081523",
          "K143570",
          "K111987",
          "K082348",
          "K120480",
          "K111010",
          "K153086",
          "K103500"
        ],
        "registration_number": [
          "2134265",
          "3013556777",
          "3002807314",
          "2126666",
          "3012121095",
          "2011171",
          "3013944123",
          "1000121056",
          "2124215",
          "3004091615",
          "3004859241",
          "3002806603",
          "3013666336",
          "3011471056",
          "2024024",
          "2939561",
          "2024168",
          "1016427",
          "1319639",
          "3004742232",
          "2183744",
          "3007738736",
          "3007695959",
          "2183870",
          "9617601"
        ],
        "fei_number": [
          "3013556777",
          "3004635528",
          "3002807314",
          "3002534070",
          "1000138054",
          "2126666",
          "3012121095",
          "3002095335",
          "2011171",
          "3013944123",
          "1000121056",
          "2124215",
          "3004091615",
          "3004859241",
          "3002806603",
          "3013666336",
          "3011471056",
          "2024024",
          "2024168",
          "1016427",
          "3004742232",
          "2183744",
          "3007738736",
          "3007695959",
          "2183870"
        ],
        "device_name": "Temporary Carotid Catheter For Embolic Capture",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1250",
        "device_class": "2"
      }
    }
  ]
}