Cardiovascular Systems Recalls Wirion Embolic Protection System Due to Filter Breaks

Cardiovascular Systems is voluntarily recalling its Wirion embolic protection systems because of reports of the filter breaking during retrieval.

The embolic protection filter is used to capture blood clots and debris that can be associated with all types of peripheral vascular intervention procedures. The 697 devices being recalled were distributed in the U.S. between March 22 and Nov. 15, according to the St. Paul, Minn.-based company.

Cardiovascular Systems said it has received nine complaints of filter breakage during retrieval. Filter breakage may result in an embolism in the device, which could require another medical intervention.