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# Cardiovascular Systems Recall Wirion Device
- URL: https://www.fdaweb.com/cardiovascular-systems-recall-wirion-device/
- Published: 2022-01-10T12:00:00.000Z
- Updated: 2026-09-14T17:28:00.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150896

Cardiovascular Systems has initiated a Class 1 recall of its Wirion system due to complaints about filter breakage during retrieval. The device is used to hold and remove debris or blood clots from the lower limbs that can be associated with atherectomy procedures. “Under certain circumstances, such as when the filter basket is too full, the filter assembly may become difficult to withdraw,” a [recall notice ](https://www.fda.gov/medical-devices/medical-device-recalls/cardiovascular-systems-inc-recalls-wirion-embolic-protection-device-due-complaints-filter-breakage?ref=fdaweb.com)says. “In this situation, withdrawal may cause the Wirion system filter component to tear or separate, which may result in serious adverse events such as embolization, need for additional medical procedures, or possibly death.” Cardiovascular Systems has received reports on nine device malfunctions, but no reports of death related to the issue, it says.