BEUDAMED
    FDA Recall Completed

    Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device

    Recall: Z-2580-2026 · Initiated May 11, 2026

    Recall

    Recall Number
    Z-2580-2026
    Event Number
    99063
    Firm
    Boston Scientific Corporation
    FEI Number
    3002095335
    Product Code
    LKK
    Status
    Completed
    Root Cause
    Process control
    Initiated
    May 11, 2026
    Posted
    June 25, 2026
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device

    Reason

    There is the potential for leakage along the drug pathway from the pump through the end of the catheter.

    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: "Instructions: " Immediately stop further use of this specific Intera HAI Pump (S/N 20175). " A Boston Scientific representative will retrieve the impacted device and process the return. " Complete and return the enclosed Reply Verification Tracking Form per the included instructions. " Report any adverse events or quality concerns associated with the use of this device to Boston Scientific via email at [email protected] or FDA s MedWatch Adverse Event Reporting program [www.fda.gov/MedWatch/report.htm or 1.800.FDA.1088 (332.1088)]." The unit was collected by a representative of the firm and subsequently destroyed.

    Distribution

    US Nationwide distribution in the state of OH.

    Quantity

    1 device