CSI Initiates Voluntary Recall of Wirion Embolic Protection System

November 24, 2021—Cardiovascular Systems, Inc. (CSI) announced it has initiated a voluntary recall of unused Wirion embolic protection systems because of complaints of filter breakage during retrieval.

The company has informed all affected health care facilities to discontinue the use of Wirion immediately and return the unused products to CSI. The FDA has also been notified.

To date, CSI has received nine complaints of filter breakage during retrieval. Filter breakage may result in device embolism and possible additional intervention.

The company advised that it plans to voluntarily recall all Wirion units currently in customer inventory. In total, 697 devices were distributed in the United States between March 22, 2021, and November 15, 2021. All lots of model WRN-D6 of the Wirion embolic protection device are being recalled.

Physicians and health care facilities can direct questions to their CSI representative or, call 651-259-2800. Adverse reactions or quality problems experienced with the use of the Wirion system may be reported to the FDA MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm or by regular mail or by fax complete and submit the report. Forms can be downloaded at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.