Cardiovascular Systems Inc. has issued a voluntary recall of unused WIRION® Embolic Protection systems due to complaints of filter breakage during retrieval. The Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall.

WIRION is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris) while performing atherectomy in calcified lesions of the lower extremities.

The recall was initiated following reports of 9 device malfunctions. Specifically, the filter component may tear or separate during withdrawal when the filter basket is too full. This may result in embolization and require additional medical interventions. At this time, there have been no reports of death related to this issue.

The Company is recalling a total of 697 WIRION Embolic Protection devices distributed in the United States between March 22, 2021 to November 15, 2021.

Adverse events or quality problems should be reported to the FDA’s MedWatch program.

For more information regarding this recall contact Cardiovascular Systems Inc. at (651) 259-2800. 

References

  1. Cardiovascular Systems, Inc recalls WIRION Embolic Protection Device due to complaints of filter breakage during retrieval. News 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.
  2. Cardiovascular Systems, Inc. initiates voluntary recall of WIRION® Embolic Protection System. News 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.