Cardiovascular Systems Recalls Unused WIRION Embolic Protection Systems

(RTTNews) - Cardiovascular Systems Inc. (CSII) has initiated a voluntary recall of unused WIRION Embolic Protection Systems due to complaints of filter breakage during retrieval.

The company said it has informed all affected healthcare facilities to discontinue use of WIRION immediately and return unused product.

The company has also notified the U.S. Food and Drug Administration. To date, CSI has received 9 complaints of filter breakage during retrieval. Filter breakage may result in device embolism and possible additional intervention.

The company plans to voluntarily recall all WIRION units currently in customer inventory. In total, 697 devices were distributed in the U.S. between March 22, 2021 and November 15, 2021.

The Wirion distal embolic protection filter is used to capture thrombus and debris that can be associated with all types of peripheral vascular intervention procedures, including atherectomy. Wirion is indicated for use as an EPS to contain and remove embolic material (thrombus/debris) while performing atherectomy in calcified lesions of the lower extremities. The Wirion EPS has received FDA clearance and CE Mark approval.