Cardiovascular Systems Inc (CSI) has recalled its Wirion embolic protection device (Wirion) due to complaints that the filter may break during retrieval, according to a notice posted on the US Food and Drug Administration (FDA) website.
The Wirion system is used to hold and remove debris or blood clots from the lower limbs during atherectomy procedures.
“Under certain circumstances, such as when the filter basket is too full, the filter assembly may become difficult to withdraw. In this situation, withdrawal may cause the Wirion system filter component to tear or separate, which may result in series adverse events such as embolization, need for additional medical procedures or possibly death,” the recall notice states.
The FDA has identified this as a Class I recall, the most serious type, due to the risk for serious injury or death.
To date, CSI has received nine reports of device malfunctions related to this issue. No deaths have been reported.
The recall includes all products and lots of the Wirion system (Model: WRN-D6) manufactured between January 3, 2021, and August 16, 2021, and distributed nationwide between March 22, 2021, and November 15, 2021.
A total of 697 devices have been recalled.
CSI, based in St. Paul, Minnesota, sent an urgent recall notice to all affected customers asking them to discontinue use of all Wirion units and return unused product to the company.
Physicians and healthcare facilities can direct questions to their CSI representative or by calling 651-259-2800.
Adverse reactions or quality problems related to this recall should be reported to the FDA’s MedWatch program.