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See today's BioWorld MedTech
Home » FDA says Wirion embolic protection device recall a class I event
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FDA says Wirion embolic protection device recall a class I event

Jan. 11, 2022
By Mark McCarty
The FDA reported a class I recall of the Wirion embolic protection device by Cardiovascular Systems Inc. (CSI), of St. Paul, Minn., due to reports of nine instances of device malfunction. The agency said the filter portion of the device can be difficult to withdraw under some circumstances and thus lead to separation, although the FDA noted that no deaths have been reported in association with the issue despite the risk of embolization. The FDA’s device center also posted a Jan. 11 notification against the use of two tests by Lusys Labs Inc., of San Diego, for the SARS-CoV-2 virus.
BioWorld MedTech Regulatory Cardiovascular Coronavirus Diagnostics U.S. FDA Product recall

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