{
  "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": 1
    }
  },
  "results": [
    {
      "cfres_id": "220721",
      "product_res_number": "Z-2580-2026",
      "event_date_initiated": "2026-05-11",
      "event_date_posted": "2026-06-25",
      "recall_status": "Completed",
      "res_event_number": "99063",
      "product_code": "LKK",
      "pma_numbers": [
        "P890055"
      ],
      "product_description": "Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device",
      "code_info": "GTIN 00850014110147, Serial Number 20175",
      "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": "Clara Johnson\n763-494-1133",
      "reason_for_recall": "There is the potential for leakage along the drug pathway from the pump through the end of the catheter.",
      "root_cause_description": "Process control",
      "action": "Boston Scientific issued an Urgent Medical Device Removal - Immediate Action Required notice to it sole consignee on 5/11/2026 via hand delivery.  The notice explained the issue and requested the following:  \n\"Instructions:\n\" Immediately stop further use of this specific Intera HAI Pump (S/N 20175).\n\" A Boston Scientific representative will retrieve the impacted device and process the\nreturn.  \n\" Complete and return the enclosed Reply Verification Tracking Form per the included\ninstructions.  \n\" Report any adverse events or quality concerns associated with the use of this device to\nBoston Scientific via email at HAI-quality@bsci.com or FDA s MedWatch Adverse Event\nReporting program [www.fda.gov/MedWatch/report.htm or 1.800.FDA.1088 (332.1088)].\"  \nThe unit was collected by a representative of the firm and subsequently destroyed.",
      "product_quantity": "1 device",
      "distribution_pattern": "US Nationwide distribution in the state of OH.",
      "openfda": {
        "pma_number": [
          "P990034",
          "P860004",
          "P140032",
          "P890055",
          "P800036",
          "P080012"
        ],
        "registration_number": [
          "2135338",
          "2246552",
          "1722746",
          "3018094310",
          "3007829657",
          "2182207",
          "3003174284",
          "2183319",
          "2124215",
          "3004209178",
          "2523676",
          "1422634",
          "3004593495",
          "2032227",
          "3030198397",
          "1526611",
          "3003120897",
          "3009183442",
          "3015537318"
        ],
        "fei_number": [
          "1000306216",
          "2246552",
          "3005700659",
          "3018094310",
          "3007829657",
          "2182207",
          "1000514656",
          "3003174284",
          "2183319",
          "2124215",
          "2523676",
          "3004593495",
          "3030198397",
          "1526611",
          "3003166194",
          "3003120897",
          "3009183442",
          "3015537318",
          "3004369318"
        ],
        "device_name": "Pump, Infusion, Implanted, Programmable",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}