BEUDAMED
    FDA Recall Terminated

    TAXUS Express Paclitaxel-Eluting MONORAIL Coronary Stent System (3.5 x 32mm). On August 5, 2004 an additional 38 lots were added to this recall, the following TAXUS Express2 Paclitaxel-Eluting Coronary Stent System Part Numbers correspond to the lot numbers listed at the end of the code information below. US part# H7493897024250 H7493897032270 H7493897020300 H7493897020350 H7493897032300 H7493897020350 H7493897024300 H7493897020300 H7493897020300 H7493897032350 H7493897020250 H7493897020270 H7493897024300 H7493897032350 H7493897032270 H7493897020350 H7493897024300 H7493897024250 H7493897024250 H7493897020300 H7493897032350 H7493897032350 H7493897024350 H7493897024250 H7493897024250 H7493897016300 H7493897032350 H7493897024350 H7493897016350 H7493897032300 H7493897016350 H7493897016350 H7493897024350 H7493897016250 H7493897016250 H7493897024300 H7493897024350 H7493897016250 OUS part# H7493800132270 H7493800132270 H7493800132350 H7493800132270 H7493800124350

    Recall: Z-1052-04 · Initiated July 1, 2004

    Recall

    Recall Number
    Z-1052-04
    Event Number
    29479
    Firm
    Boston Scientific Scimed
    FEI Number
    3002095335
    Product Code
    NIQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 1, 2004
    Posted
    July 20, 2004
    Terminated
    February 22, 2006
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    TAXUS Express Paclitaxel-Eluting MONORAIL Coronary Stent System (3.5 x 32mm). On August 5, 2004 an additional 38 lots were added to this recall, the following TAXUS Express2 Paclitaxel-Eluting Coronary Stent System Part Numbers correspond to the lot numbers listed at the end of the code information below. US part# H7493897024250 H7493897032270 H7493897020300 H7493897020350 H7493897032300 H7493897020350 H7493897024300 H7493897020300 H7493897020300 H7493897032350 H7493897020250 H7493897020270 H7493897024300 H7493897032350 H7493897032270 H7493897020350 H7493897024300 H7493897024250 H7493897024250 H7493897020300 H7493897032350 H7493897032350 H7493897024350 H7493897024250 H7493897024250 H7493897016300 H7493897032350 H7493897024350 H7493897016350 H7493897032300 H7493897016350 H7493897016350 H7493897024350 H7493897016250 H7493897016250 H7493897024300 H7493897024350 H7493897016250 OUS part# H7493800132270 H7493800132270 H7493800132350 H7493800132270 H7493800124350

    Reason

    On a few occasions the balloon has failed to deflate within one minute after deployment of the stent.

    Action

    July 2 and 16, 2004 recall letters were sent to user accounts, such as Hospitals and clinics of the need to recall TAXUS Express2 Paclitaxel-Eluting and Express 2 Coronary Stent Systems. Recall was due to characteristics in the delivery catheters that had the potential to impede balloon deflation during a coronary angioplasty procedure, a condition known as focal neckdown. An additional 38 lots were added to the recall on August 5, 2004, for the same reason.

    Distribution

    Nationwide and Canada

    Quantity

    205,983 units plus additional 3,000 units recalled on 8/5/04.