The FDA has announced that Cardiovascular Systems is recalling its Wirion embolic protection device due to issues with the filter breaking off during the retrieval process. The recall covers a total of 697 devices.
The Wirion device was designed to hold and remove blood clots or other debris from a patient’s lower limbs, typically during an atherectomy procedure.
“Under certain circumstances, such as when the filter basket is too full, the filter assembly may become difficult to withdraw,” according to the announcement. “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, need for additional medical procedures, or possibly death.”