Cardiovascular Systems Inc. has issued a voluntary recall of unused WIRION® Embolic protection systems due to complaints of filter breakage during recovery. The Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall.
WIRION is indicated as an embolic protection system to contain and remove embolic material (thrombus / debris) when performing atherectomy in calcified lesions of the lower limbs.
The recall was initiated following reports of 9 device malfunctions. Specifically, the filter element may tear or separate upon removal when the filter basket is overfilled. This can lead to embolization and require additional medical interventions. To date, no deaths related to this issue have been reported.
The Company is recalling a total of 697 WIRION embolic protection devices distributed in the United States between March 22, 2021 and November 15, 2021.
Adverse events or quality issues should be reported to the FDA MedWatch Program.
For more information regarding this recall, contact Cardiovascular Systems Inc. at (651) 259-2800.
- Cardiovascular Systems, Inc. is recalling the WIRION Embolic Protection Device due to complaints about filter rupture during recovery. Press release. Cardiovascular Systems, Inc. November 22, 2021. Accessed January 11, 2022. https://www.fda.gov/medical-devices/medical-device-recalls/cardiovascular-systems-inc-recalls-wirion-embolic-protection-device-due-complaints-filter-breakage.
- Cardiovascular Systems, Inc. Launches Voluntary Recall of WIRION® Embolic protection system. Press release. Cardiovascular Systems, Inc. November 24, 2021. Accessed January 11, 2022. https://investors.csi360.com/news-releases/press-release-details/2021/Cardiovascular-Systems-Inc.-Initiates-Voluntary-Recall-of-WIRION-Embolic-Protection-System/default.aspx.
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