Cardiovascular Systems Recalls Wirion Embolic Protection System

Cardiovascular Systems Inc CSII has commenced a voluntary recall of its WIRION Embolic Protection Systems (WIRION).

• The unused WRN-D6 models of the WIRION device are being recalled due to receiving complaints regarding filter breakage at the time of retrieval.
• The Company stated that the filter breakage might cause device embolism as well as additional intervention.
• All affected healthcare facilities were informed to stop using and return the unused WIRION devices to the Company.
• CSI has also notified the FDA regarding the voluntary recall.
• The Company has received nine filter breakage complaints so far and plans to recall all the devices currently in customer inventory.
• Between 22 March and 15 November, approximately 697 devices were distributed in the US.
• WIRION is a rapid exchange, pre-loaded filter used as an embolic protection system for removing embolic material (thrombus/debris) while performing atherectomy in calcified lesions of the lower extremities.
• In March, CSI acquired a portfolio of peripheral support catheters from WavePoint Medical.
• These catheters are used during peripheral vascular intervention (PVI) procedures for guidewire support to aid in lesion crossing and for guidewire exchanges.
• CSI expects to introduce the acquired catheters as its new ViperCross line in the first half of its fiscal year, ending on 30 June 2022.
• Price Action: CSII shares closed at $23.72 on Wednesday.