Sam Brusco, Associate Editor01.10.22
Cardiovascular Systems Inc. (CSI) has recalled its WIRION embolic protection devices manufactured between January 3 and August 6, 2021. The FDA has designated it as a Class I recall. 697 devices were distributed from March 22 to November 15, 2021. CSI began the recall on November 22.
WIRION holds and removes debris or blood clots from lower limbs that can be associated with atherectomies.
The company recalled WIRION because of complaints about filter breakage during retrieval. When the filter basket is too full, the assembly may become difficult to withdraw. In this situation, withdrawal can cause the system filter to tear or separate, resulting in embolization, need for additional procedures, or potentially death.
CSI received reports of nine device malfunctions so far, but no reports of death related to the issue.
Customers were instructed to remove the device from distribution and return it to CSI.
Find more information about the recall here.
WIRION holds and removes debris or blood clots from lower limbs that can be associated with atherectomies.
The company recalled WIRION because of complaints about filter breakage during retrieval. When the filter basket is too full, the assembly may become difficult to withdraw. In this situation, withdrawal can cause the system filter to tear or separate, resulting in embolization, need for additional procedures, or potentially death.
CSI received reports of nine device malfunctions so far, but no reports of death related to the issue.
Customers were instructed to remove the device from distribution and return it to CSI.
Find more information about the recall here.