The FDA determined that Cardiovascular Systems’ recall of some of its Wirion embolic protection devices is Class I, the most serious kind.

St. Paul, Minnesota–based Cardiovascular Systems is recalling all products and lots of its Wirion embolic protection device due to complaints of filter breakage during retrieval. It includes devices with manufacturing dates of Jan. 3, 2021, to Aug. 16, 2021, with distribution dates of Mar. 22, 2021 to Nov. 15, 2021. There have been 697 devices recalled in the U.S., and the company has received reports of nine device malfunctions.

There are no reports of deaths related to the device.

In some circumstances, such as when the filter basket is too full, the filter assembly could become difficult to withdraw. Withdrawal could cause the filter component to tear or separate, which can result in adverse events such as embolization, need for additional medical procedures or possibly death.

Cardiovascular Systems designed the Wirion embolic protection device to hold and remove debris or blood clots from the lower limbs that can be associated with atherectomy procedures.

The company issued a voluntary recall of the devices in November last year when it informed all affected healthcare facilities to discontinue use of the device immediately and to return all unused products.