BEUDAMED
    FDA Recall Open, Classified

    OptiCross Coronary Imaging Catheter, REF H749518080120

    Recall: Z-1396-2024 · Initiated March 5, 2024

    Recall

    Recall Number
    Z-1396-2024
    Event Number
    94162
    Firm
    Boston Scientific Corporation
    FEI Number
    3002095335
    Product Code
    OBJ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    March 5, 2024
    Posted
    March 28, 2024
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    OptiCross Coronary Imaging Catheter, REF H749518080120

    Reason

    Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.

    Action

    Boston Scientific issued an Urgent Medical Device Removal notice to its consignees on 03/05/2024 via overnight delivery. The notice explained the issue, potential risk, and requested the consignee immediately discontinue use, segregate, and respond pending return of the device.

    Distribution

    International distribution to the country of Japan.

    Quantity

    239 units