January 10, 2022 — Cardiovascular Systems Inc. (CSI) is recalling the Wirion atherectomy embolic protection device system due to complaints of filter breakage during retrieval. Under certain circumstances, such as when the filter basket is too full, the filter assembly may become difficult to withdraw. In this situation, withdrawal may cause the Wirion system filter component to tear or separate, which may result in series adverse events such as embolization or the need for additional medical procedures.
