Wirion Embolic Protection System Recalled Over Filter Breakage

The Wirion embolic protection system, used to capture debris or blood clots associated with atherectomy procedures in the lower extremities, has been recalled by Cardiovascular Systems Inc following reports of filter breakage during retrieval. Users are being asked to return affected products to the company.

On Monday, the US Food and Drug Administration announced the action, initiated on November 22, 2021, as a class I recall, the most serious type.

“Under certain circumstances, such as when the filter basket is too full, the filter assembly may become difficult to withdraw,” the agency notes. “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.”

There have been reports of nine device malfunctions, but no deaths, associated with the issue.

The recall applies to all products and lots, with manufacturing dates ranging from January 3 to August 16, 2021, and distribution dates from March 22 to November 15, 2021. It affects 697 devices in the United States, as well as some in the Netherlands.