Cardiovascular Systems (CSII) Announces Voluntary Recall of WIRION

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Cardiovascular Systems, Inc. Initiates Voluntary Recall of WIRION® Embolic Protection System

November 24, 2021 4:05 PM EST

ST. PAUL, Minn.--(BUSINESS WIRE)-- Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII) has initiated a voluntary recall of unused WIRION Embolic Protection Systems (WIRION) due to complaints of filter breakage during retrieval.

CSI has informed all affected healthcare facilities to discontinue use of WIRION immediately and return unused product to CSI. The U.S. Food and Drug Administration (FDA) has also been notified. To date, CSI has received 9 complaints of filter breakage during retrieval. Filter breakage may result in device embolism and... More