BEUDAMED
    FDA Recall Terminated

    WALLSTENT Endoprostheses with UNISTEP Plus Delivery System.

    Recall: Z-1340-04 · Initiated July 9, 2004

    Recall

    Recall Number
    Z-1340-04
    Event Number
    29560
    Firm
    Boston Scientific Scimed
    FEI Number
    3002095335
    Product Code
    JCT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 9, 2004
    Posted
    August 13, 2004
    Terminated
    January 5, 2007
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    WALLSTENT Endoprostheses with UNISTEP Plus Delivery System.

    Reason

    Specific lots of the WALLSTENT Endoprosthesis with UNISTEP Plus Delivery System were packaged without one of the three required directions for use.

    Action

    Boston Scientific is notifying sales representatives and customers of recall along with instructions regarding the return of potentially affected product.

    Distribution

    Inside the US only.

    Quantity

    82 units (H965402100) aa7 units (H965402100)