FDA designates recall of embolic protection device as class I
Cardiovascular Systems Inc. announced a recall of its embolic protection device due to complaints of filter breakage during retrieval of lower limb blood clots associated with atherectomy procedures in lower limbs.
The FDA has identified the recall as class I, the most serious type.
According to a press release from the FDA, the system (Wirion) filter assembly may become difficult to withdraw and break under certain circumstances, such as when the filter basket is too full. Breakage may result in adverse events including embolization, need for additional medical procedures or death.
The affected devices were distributed between March 22, and Nov. 15, 2021.
According to the release, Cardiovascular Systems Inc. received reports of nine device malfunctions and no deaths related to this issue.
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