{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "221301",
      "product_res_number": "Z-2773-2026",
      "event_date_initiated": "2026-06-08",
      "event_date_posted": "2026-07-22",
      "recall_status": "Open, Classified",
      "res_event_number": "99326",
      "product_code": "OUT",
      "pma_numbers": [
        "P100018S026"
      ],
      "product_description": "Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027\nREF PED2-300-12",
      "code_info": "UDI: 00763000448806/ Lot: D062612, 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": "Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.",
      "root_cause_description": "Labeling Change Control",
      "action": "On June 25, 2026, Medtronic (parent company of Micro Therapeutics)  issued a Urgent Medical Device Expansion to affected consignees via visit. The revised notification included additional lots of product. The initial notification was issued on June 4, 2026 via visit. Medtronic ask consignees to take the following actions: \n\n1. Do NOT use any impacted Pipeline Shield products. Remove and quarantine all unused\nimpacted product units in your inventory.\n2. Return the impacted product(s) to Medtronic. Your 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.\n\n4. Please share this communication within your organization, with other organizations where impacted devices have been transferred, and any other associated organizations that may be impacted by this action. \n5. Please maintain a copy of this letter for your records and the records of your patients with Pipeline Shield.",
      "product_quantity": "13 units",
      "distribution_pattern": "US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, \tWA.",
      "openfda": {
        "pma_number": [
          "P100018",
          "P180027",
          "P170024"
        ],
        "registration_number": [
          "3022418643",
          "3015550451",
          "3019807891",
          "2029214",
          "3008881809",
          "3009380063",
          "3007628272",
          "3008837339",
          "3010079067",
          "1226348",
          "3008307705",
          "3013556777",
          "2011171",
          "3008853977"
        ],
        "fei_number": [
          "3022418643",
          "3015550451",
          "3019807891",
          "3002947440",
          "3008881809",
          "3009380063",
          "3007628272",
          "3008837339",
          "3010079067",
          "1000220862",
          "3008307705",
          "3013556777",
          "2011171",
          "3008853977"
        ],
        "device_name": "Intracranial Aneurysm Flow Diverter",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}