{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "140075",
      "product_res_number": "Z-0120-2016",
      "event_date_initiated": "2015-09-04",
      "event_date_posted": "2015-10-14",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-05-18",
      "res_event_number": "72165",
      "product_code": "OUT",
      "pma_numbers": [
        "P100018"
      ],
      "product_description": "-Pipeline Embolization Device\n-Pipeline Flex Embolization Device\n\nThe Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based delivery system.  The Pipeline and Pipeline Flex embolization device implant is a braided, multi-alloy, mesh cylinder woven from platinum/tungsten and cobalt-chromium-nickel alloy wires.\n\nThe Pipeline and Pipeline Flex Embolization Devices are indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments.",
      "code_info": "Pipeline Model Number\tLot Number FA-77250-16V06\t9724629 FA-77350-16V10\tA024276 FA-77350-16V12\tA012865 FA-77350-18Vl0\tA013596 FA-77350-20V12\tA012039 FA-77375-14V12\tA013029 FA-77375-16Vl2\tA011629 FA-77375-16Vl2\tA029223 FA-77375-16Vl2\tA031361 FA-77375-18V10\tA024213 FA-77375-20Vl2\tA029315 FA-77400-14V12\tA012885 FA-77425-18V12\tA026942 FA-77450-14V12\tA013028 FA-77475-20Vl2\tA012383 FA-77500-16Vl2\tA029316   Pipeline Flex Model Number\tLot Number PED-400-20VO1\t9977371 PED-475-20V01\tA047151 PED-375-18V01\t9971250",
      "firm_fei_number": "3004904811",
      "recalling_firm": "Micro Therapeutics Inc, Dba Ev3 Neurovascular",
      "address_1": "9775 Toledo Way",
      "city": "Irvine",
      "state": "CA",
      "postal_code": "92618-1811",
      "additional_info_contact": "949-837-3700",
      "reason_for_recall": "The firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.S. since the devices were shipped with an EU version of the Instructions for Use.",
      "root_cause_description": "Process control",
      "action": "The firm, Medtronic, sent a \"Notification of Recall\" letter dated 09/04/15 to its customers. The letter described the product, problem and actions to be taken.  \n\nThe firm's letter instructed that customers return the Pipeline Embolization Devices to Medtronic for replacement with the US version of product.  \n\nThe firm asks customers to take the following steps:\n1) Stop using this product immediately.\n2) Segregate this product from other Inventory.\n3) Fill out the reply form and fax to the completed form directly to Customer Service at (800) 716-6700 or email to: andrew.schramm@medtronic.com. Customer Service will issue an RGA number for the return of the affected product back to Medtronic Neurovascular.\n4) Upon receipt of an RGA number, write the RGA number on the FEDEX\nslip and send the product back to: Medtronic Neurovascular, Attention: Product Recall, 9775 Toledo Way, Irvine, CA 92618.  Prepaid and preaddressed FEDEX slips are enclosed for convenience.\n5. Once they receive the returned units, product  replacement units will be shipped directly to customers.  The local Neurovascular representative can also be available to assist in expediting the exchange of product.\n\nFor any questions contact directly at 949-680-1340.",
      "product_quantity": "23 devices",
      "distribution_pattern": "US Distributions to states of: TN, KY, VA, WI, MO, IL, UT, OR, and MD. \n\nNo foreign consignees.",
      "openfda": {
        "pma_number": [
          "P180027",
          "P170024",
          "P100018"
        ],
        "registration_number": [
          "3019807891",
          "3015550451",
          "2029214",
          "3008837339",
          "3008881809",
          "3008853977",
          "3008307705",
          "1226348",
          "3022418643",
          "3013556777",
          "2011171",
          "3009380063",
          "3010079067",
          "3007628272"
        ],
        "fei_number": [
          "3019807891",
          "3015550451",
          "3002947440",
          "3008837339",
          "3008881809",
          "3008853977",
          "3008307705",
          "1000220862",
          "3022418643",
          "3013556777",
          "2011171",
          "3009380063",
          "3010079067",
          "3007628272"
        ],
        "device_name": "Intracranial Aneurysm Flow Diverter",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}