Merit basixCOMPAK™, PhD™ Hemostasis Valve, and basixSKY™ Inflation Syringe

Merit Medical became aware of a manufacturing defect after an increased number of complaints. Investigation into the issue concluded that the lack of fluorinated silicone in the bleed back seal (the secondary valve) caused by the mix of incorrect silicone during production line influenced the performance of the PhD™ Hemostasis Valve. The lack of silicone was found to prevent the secondary valve from releasing and closing properly. The valve cap potentially would remain depressed causing leakage.

Recall start date: July 30, 2025