The FDA determined that Cardiovascular Systems’ recall of some of its Wirion embolic protection devices is Class I, the most serious kind.
St. Paul, Minnesota–based Cardiovascular Systems is recalling all products and lots of its Wirion embolic protection device due to complaints of filter breakage during retrieval. It includes devices with manufacturing dates of Jan. 3, 2021, to Aug. 16, 2021, with distribution dates of Mar. 22, 2021 to Nov. 15, 2021. There have been 697 devices recalled in the U.S., and the company has received reports of nine device malfunctions. There are no reports of deaths related to the device.
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