Cardiovascular Systems Inc. has recalled its WIRION Embolic Protection Device after complaints of filter breakage during retrieval.
The U.S. Food and Drug Administration (FDA) identified this Monday as a Class I recall, the most serious type, meaning that the use of such devices can result in serious injury or death.
The device is used to hold and remove debris and blood clots from the lower limbs that can be associated with atherectomy procedures, according to the FDA’s recall notice.
Under certain circumstances, such as when the filter basket is too full, the filter assembly may become difficult to withdraw, the FDA said. When this happens, 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 agency said.
Cardiovascular Systems Inc. has received reports of nine device malfunctions and no reports of death related to this device issue.
In a Nov. 21 press release announcing its voluntary recall, Cardiovascular Systems Inc. noted that it informed all affected healthcare facilities to stop using the device immediately and return any unused products.
Physicians and healthcare facilities can direct questions to their Cardiovascular Systems Inc. representative or call (651) 259-2800. Problems may also be reported to the FDA’s MedWatch program.
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