US-based cardiovascular devices maker Cardiovascular Systems (CSI) has announced the voluntary recall of unused WIRION embolic protection systems.

The WRN-D6 model WIRION embolic protection devices were recalled due to complaints related to filter breakage at the time of retrieval.

Filter breakage may result in device embolism and require additional intervention.

Between 22 March and 15 November this year, CSI has distributed a total of 697 devices in the US.

The company has received nine complaints regarding filter breakage so far and is planning to recall all the devices currently in customer inventory.

All the affected healthcare facilities were informed to immediately discontinue the use of WIRION and return the unused product to the company.

CSI has also notified the US Food and Drug Administration (FDA) regarding the voluntary recall.

WIRION is a rapid exchange, pre-loaded filter, used as an embolic protection system for removing embolic material during atherectomy, in calcified lesions of the lower extremities.

The device can be used for vessels with a diameter between 3.5mm and 6.0mm, at the site of filter basket placement, and can be used with commercially available 0.014″ guide wires.

WIRION is not indicated for patients with a severe allergy to Heparin, patients with an uncorrected bleeding disorder, and those who are not eligible for anticoagulant and antiplatelet therapy.

In March this year, the company acquired a portfolio of peripheral support catheters from WavePoint Medical, which focuses on high-performance microcatheters.

The catheters are used during peripheral vascular intervention (PVI) procedures for guidewire support to facilitate lesion crossing and guidewire exchanges.