FDA Issues Update on Cardiovascular Systems’ Wirion Recall

The FDA issued on update on Cardiovascular Systems’ November recall of its Wirion embolic protection systems, deeming it a Class 1 recall because of the risk of serious injury or death.

The Wirion system is used to hold and remove debris or blood clots from the lower limbs that can be associated with atherectomy procedures.

The recall in late November followed complaints of filters breaking during retrieval. The 697 recalled devices that were distributed in the U.S. between March 22 and Nov. 15, 2021. Cardiovascular Systems has received nine reports of device malfunctions but no reports of deaths, the FDA said.