Recombinant activated factor VII may be effective in patients with severe bleeding following congenital heart disease surgery requiring cardiopulmonary bypass. From August 2009 through June 2011, 13 patients (median age, 5 months) were given recombinant activated factor VII for severe bleeding after open heart surgery, preventing sternal closure 2 h after completion of cardiopulmonary bypass, or chest tube drainage >10 mL · kg(-1) · h(-1) for 2 h. The median dose was 75 μg · kg(-1). The response was positive if postoperative bleeding decreased, permitting sternal closure in the operating room, or if there was >50% decrease in chest tube drainage. The 3 patients who received factor VIIa in the operating room had successful sternal closure within 1 h. Of the 10 patients who received factor VIIa in the intensive care unit, drainage decreased to <50% in 1 h in 6 cases, and a second dose was required in 4. None required surgical reexploration. There were 4 deaths, none was related to bleeding. Nine patients were discharged (median hospital stay, 29 days) and were doing well after 3 months. There were no thrombotic complications. Recombinant activated factor VII may be an effective rescue therapy for severe postoperative hemorrhage.