The unused WRN-D6 models of the WIRION device are being recalled due to receipt of complaints regarding filter breakage at the time of retrieval.
The company stated that the filter breakage may 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 US Food and Drug Administration (FDA) regarding the voluntary recall.
The company has received nine filter breakage complaints so far and plans to recall all the devices which are currently in customer inventory.
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Between 22 March and 15 November, approximately 697 devices were distributed in the US.
WIRION is a rapid exchange, pre-loaded filter, which is used as an embolic protection system for removing embolic material (thrombus/debris) while performing atherectomy in calcified lesions of the lower extremities.
The single-use product is provided sterile and can be used with commercially available 0.014in guide wires.
These catheters are used during peripheral vascular intervention (PVI) procedures for guidewire support to aid in lesion crossing and for guidewire exchanges.
Physicians use support catheters in about 50% of PVIs, mostly in complex and below-the-knee interventions.
CSI expects to introduce the acquired catheters as its new ViperCross line in the first half of its fiscal year, which ends on 30 June 2022.