Objective To evaluate the efficacy and safety of a novel ultrafiltration device (FQ-16) in patients with acute decompensated heart failure and diuretic resistance. Methods A retrospective study was carried out on 35 patients with acute decompensated heart failure and diuretic resistance who were hospitalized in our department from November 2015 to June 2017. They were treated using a new ultrafiltration device (FQ-16). The body weight, systolic blood pressure (SBP), diastolic blood pressure (DBP), serum creatinine (SCr), blood urea nitrogen (BUN), heart rate (HR), hemoglobin (Hb), platelet (PLT) count, hematocrit (Hct), dyspnea score, central venous pressure (CVP), arterial oxygen saturation (SaO₂), N-terminal pro-brain natriuretic peptide (NT-proBNP), left ventricular ejection fraction (LVEF) before and after the ultrafiltration treatment, and the incidence of major adverse event were measured and observed to evaluate the clinical efficiency and safety. Clinical data were analyzed by SPSS statistics 17.0. The differences were compared with t test. Results No significant differences were found in SBP, DBP, HR, SCr, BUN, Hb, Hct, PLT, K⁺,Na⁺ and Cl- level before and after the last ultrafiltration (P>0.05). But body mass, dyspnea score, SaO₂, CVP and NT-proBNP were improved obviously (P<0.05). During and within 72 h after the ultrafiltration, no death, myocardial infarction or aggravation of heart failure was observed, neither treatment-required hypotension occurred. Two very old patients experienced conscious disturbance in the treatment, and relieved in 24 h after ultrafiltration. Conclusion The novel ultrafiltration device FQ-16 adequately relieves hypervolemia and dyspnea, but has no effect on blood pressure, electrolytes, and renal function in patients with acute decompensated heart failure and diuretic resistance. No serious adverse events were observed. It is an effective and safe therapeutic method.