{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "188522",
      "product_res_number": "Z-2327-2021",
      "event_date_initiated": "2021-07-23",
      "event_date_posted": "2021-08-19",
      "recall_status": "Open, Classified",
      "res_event_number": "88369",
      "product_code": "NAW",
      "pma_numbers": [
        "P200029"
      ],
      "product_description": "TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)",
      "code_info": "GTIN 05060116920253, Lot Numbers:  001E, 002E, 004E, 005E, 006E, 007E, 114E, 690E, 692E",
      "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": "Rebecca KinKead Rubio\n763-494-1133",
      "reason_for_recall": "Potential for leaks and loosening at the patient catheter connection",
      "root_cause_description": "Component change control",
      "action": "The firm disseminated a Medical Device Product Advisory on 07/23/2021 by overnight mail delivery.  The letter explained the issue and directed users to ensure a firm connection is made between the outlet luer and the patient catheter prior to, and during ThersSphere administration.",
      "product_quantity": "4980 sets",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Belgium, Canada, Germany, Spain, France, United Kingdom/Great Britain, Hong Kong, Ireland, Israel, India, Italy, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, Switzerland, Turkey, and Argentina.",
      "openfda": {
        "pma_number": [
          "P200029",
          "P990065"
        ],
        "registration_number": [
          "3005579300",
          "3009088444",
          "3013070673",
          "2134265",
          "1450662",
          "3012690638",
          "8022247",
          "2124215"
        ],
        "fei_number": [
          "3001092088",
          "3005579300",
          "3009088444",
          "3013070673",
          "1450662",
          "3012690638",
          "3002095335",
          "2124215"
        ],
        "device_name": "Microspheres Radionuclide",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}