BEUDAMED
    FDA Recall Terminated

    Boston Scientific Scimed Radius 4.0 mm x 31 mm Self-Expanding Coronary Stent with Over-the-Wire Delivery System, Catalog Number H74917500401

    Recall: Z-0778-03 · Initiated March 17, 2003

    Recall

    Recall Number
    Z-0778-03
    Event Number
    25947
    FEI Number
    3002095335
    Product Code
    MAF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 17, 2003
    Posted
    April 22, 2003
    Terminated
    July 2, 2004
    Address
    Boston Scientific Scimed One Scimed Place Maple, Grove, MN, 55311-1566

    Description

    Boston Scientific Scimed Radius 4.0 mm x 31 mm Self-Expanding Coronary Stent with Over-the-Wire Delivery System, Catalog Number H74917500401

    Reason

    A component within the manifold of the stent delivery systems was found to have pyrogen levels above specification.

    Action

    Consignees were sent a recall letter dated March 17, 2003. The letter requested that consignees discontinue use of stents from the affected lots and return them.

    Distribution

    Nationwide in the United States

    Quantity

    7 Stent Systems