BEUDAMED
    FDA Recall Terminated

    Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X

    Recall: Z-2235-2021 · Initiated July 19, 2021

    Recall

    Recall Number
    Z-2235-2021
    Event Number
    88348
    Firm
    Cordis Corporation
    FEI Number
    1016427
    Product Code
    LIT
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 19, 2021
    Terminated
    February 16, 2023
    Address
    14201 NW 60th Ave, Miami Lakes, FL, 33014-2802

    Description

    Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X

    Reason

    The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon.

    Action

    The firm initiated the recall by letter on 07/19/2021. The letter explained the issue and requested the return of the devices.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of CA, OH, and the countries of Switzerland, Portugal, and Poland.

    Quantity

    8 units