{
  "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": "2026-10-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "222202",
      "product_res_number": "Z-3326-2026",
      "event_date_initiated": "2026-06-25",
      "event_date_posted": "2026-09-28",
      "recall_status": "Open, Classified",
      "res_event_number": "99689",
      "product_code": "OUT",
      "pma_numbers": [
        "P100018S026"
      ],
      "product_description": "Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12\r\nUDI-DI code: 00763000448806\r\n\r\nhe Pipeline Flex Embolization Device with Shield Technology consists of a permanent implant combined with a guidewire based delivery system. The Pipeline Flex Embolization Device with Shield Technology implant is a braided, multi-alloy, mesh cylinder woven from platinum/tungsten and cobalt-chromium-nickel alloy wires and 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": "Product/Catalog Number: PED2-300-12\nUDI-DI/GTIN: 00763000448806\nLot Number: #D112860",
      "firm_fei_number": "1000220862",
      "recalling_firm": "Micro Therapeutics, Inc.",
      "address_1": "9775 Toledo Way",
      "city": "Irvine",
      "state": "CA",
      "postal_code": "92618-1811",
      "additional_info_contact": "Erika Winkels\n949-837-3700",
      "reason_for_recall": "Due to incorrect label/product dimensions.  Product is supposed to be 3.00 mm in diameter, but unit is packaging was a 2.50 mm in diameter.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On 06/25/2026, an \"URGENT: MEDICAL DEVICE RECALL\" letter was sent to customers to inform them that, Medtronic has confirmed a labeling error involving implant diameter in the affected lot. Devices from Lot # D112860 labeled as PED2-300-12 (3.00 mm diameter, 12 mm length) contain 2.50 mm diameter implants instead of the labeled 3.00 mm diameter.\n\nCustomers are instructed to:\n1. Do NOT use any impacted Pipeline Flex Embolization Device with Shield Technology devices listed. Remove and quarantine all unused impacted product units in their  inventory.\n2. Return the impacted product(s) to Medtronic. Their Medtronic representative can assist in facilitating the return of product and/or identifying suitable replacement product as necessary.\n3. Complete the attached Customer Confirmation Form and email it to neuro.quality@medtronic.com.\n4. Review their records to identify any patients who may have been treated with devices from the affected lot and assess whether any follow-up is appropriate.\n5. Share this recall communication within their organization, with other organizations where impacted devices have been transferred, and any other associated organizations that may be impacted by this action. Maintain a copy of this letter for their records and the records of their patients with Pipeline Shield.\n\nFor questions - contact Medtronic at 1 (800) 633-8766 or (763) 514-4000 (Worldwide) or Email: rs.nvquality@medtronic.com",
      "product_quantity": "2",
      "distribution_pattern": "U.S. Nationwide distribution in the states of GA and TX.",
      "openfda": {
        "pma_number": [
          "P170024",
          "P100018",
          "P180027"
        ],
        "registration_number": [
          "3009380063",
          "3022418643",
          "3008307705",
          "3008837339",
          "2029214",
          "1226348",
          "3010079067",
          "3019807891",
          "3013556777",
          "3008853977",
          "2011171",
          "3015550451",
          "3008881809",
          "3007628272"
        ],
        "fei_number": [
          "3009380063",
          "3022418643",
          "3008307705",
          "3008837339",
          "3002947440",
          "3010079067",
          "1000220862",
          "3013556777",
          "3008853977",
          "2011171",
          "3015550451",
          "3019807891",
          "3008881809",
          "3007628272"
        ],
        "device_name": "Intracranial Aneurysm Flow Diverter",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}