BEUDAMED
    FDA Recall Terminated

    Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, Coronary Sinus - Extended Hook Right Tip Shape, CS-EH R, REF 7592

    Recall: Z-0805-04 · Initiated March 11, 2004

    Recall

    Recall Number
    Z-0805-04
    Event Number
    28498
    Firm
    Guidant Corp-Cpi Division
    FEI Number
    2124215
    Product Code
    DQR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 11, 2004
    Posted
    July 20, 2004
    Terminated
    October 31, 2005
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700

    Description

    Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, Coronary Sinus - Extended Hook Right Tip Shape, CS-EH R, REF 7592

    Reason

    The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery system components during lead placement.

    Action

    Starting on March 11, 2003, the firm''s representatives visited consignees, to whom the recalled catheters had been consigned, and retrieved the catheters.

    Distribution

    Nationwide in the United States.

    Quantity

    43 catheters