Cardiovascular Systems has initiated a voluntary recall of unused Wirion embolic protection systems due to complaints of filter breakage during retrieval.
Wirion is a distal embolic protection filter used to capture thrombus and debris that can be associated with all types of peripheral vascular intervention procedures, including atherectomy.
CSI has informed all affected healthcare facilities to discontinue use of Wirion immediately and return unused product to CSI. The US Food and Drug Administration (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 plans to voluntarily recall all Wirion units currently in customer inventory. In total, 697 devices were distributed in the USA between 22 March and 15 November 2021.