Cardiovascular Systems, Inc Recalls WIRION Embolic Protection Device Due to Complaints of Filter Breakage During Retrieval

Date:  01/10/22

Product Names: WIRION Embolic Protection Device

Product Codes: See Recall Database Entry

Model Numbers: All products and lots

Manufacturing Dates: January 3, 2021 to August 16, 2021

Distribution Dates: March 22, 2021 to November 15, 2021

Devices Recalled in the U.S.: 697

Date Initiated by Firm: November 22, 2021

USA-FDA Link:  https://www.fda.gov/medical-devices/medical-device-recalls/cardiovascular-systems-inc-recalls-wirion-embolic-protection-device-due-complaints-filter-breakage