Gyrus ACMI, Inc. Olympus Surgical Technologies America, QIL FY26-EMEA-19-FY26-077-F-1 ViziShot 2 FLEX, ViziShot 2 FLEX 19G

Olympus received complaints for the ViziShot 2 FLEX (19G) devices in which the hypotube component ejected from the device or plastic components detached during use. Investigation has identified that device heat-shrink material degradation and use errors can cause hypotube component ejection. Additionally, investigation has identified that the device heat-shrink material (which seals the needle) degrades during clinical use and may result in difficulty in extracting or expelling samples, fluid leakage, impaired needle deployment or retraction, or breakage of device components. To mitigate these risks, Olympus is removing all ViziShot 2 FLEX (19G) devices from the market.