January 11, 2022
FDA: Class I recall of Cardiovascular Systems’ WIRION Embolic Protection Device
Editor's Note
The Food and Drug Administration (FDA), on January 10, identified the recall of Cardiovascular Systems’ WIRION Embolic Protection Device as Class I, the most serious.
The device, which is used to hold or remove debris or blood clots from the lower limbs, was recalled because of complaints of filter breakage during retrieval.
Cardiovascular Systems has received reports of nine device malfunctions and no reports of deaths.
Distribution dates were March 22, 2021, to November 15, 2021.
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