Background: Balloon valvuloplasty in infants with symptomatic tetralogy of Fallot (TOF) may increase the pulmonary flow and prompt the growth of pulmonary arteries. Method: From 1994 to 2002, percutaneous transluminal balloon valvuloplasty (PTPV) was performed in 22 consecutive newborns and young infants (<3 months of age) with TOF. The indication included severe hypoxemia (systemic oxygen saturation below 75%, 10 cases) and repeated hypoxic spells (12 cases). The age at PTPV was 8–88 days (38 ± 34, median 27) and the body weight 2–5 kg (3.45 ± 1.15, median 3). A balloon catheter (4– 7 mm in diameter and 2 cm in length) was used to dilate the pulmonary valve. Results: No major procedure-related complications occurred. The systemic oxygen saturation increased significantly (14 ± 9%). A subsequent palliative shunt operation was avoided in 12 patients (54.5%), but 10 still needed operation (median 11 days after the PTPV). The presence of recurrent hypoxic spells before PTPV was the most important indicator for PTPV failure (p = 0.02). Conclusion: PTPV was safe and effective for symptomatic newborns and young infants with TOF, but a palliative shunt operation was still needed due to short effect, especially in those with recurrent spells before the dilation.