BEUDAMED
    FDA Recall Terminated

    Express 2 Monorail Coronary Stent Systems (bare metal stents) - balloon expandable Express 316L stainless steel Stent premounted on a MONORAIL catheter with a Dynaleap balloon.

    Recall: Z-1121-04 · Initiated July 16, 2004

    Recall

    Recall Number
    Z-1121-04
    Event Number
    29581
    Firm
    Boston Scientific Corporation
    FEI Number
    3001451463
    Product Code
    MAF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 16, 2004
    Posted
    July 27, 2004
    Terminated
    November 29, 2005
    Address
    1 Boston Scientific Pl, Natick, MA, 01760-1536

    Description

    Express 2 Monorail Coronary Stent Systems (bare metal stents) - balloon expandable Express 316L stainless steel Stent premounted on a MONORAIL catheter with a Dynaleap balloon.

    Reason

    Due to characteristics in the delivery catheters that have the potential to impede balloon deflation during a coronary angioplasty procedure.

    Action

    Press release has been issued. Institutions with affected units will receive packages outlining the recall process and should immediately discontinue use of these units. Clinician and patient inquiries may be directed to Boston Scientific.

    Distribution

    Inside U.S.

    Quantity

    82,424