Cook's recall gets FDA's highest-risk label

The FDA slaps its highest-risk Class I label on Cook Medical's recall of CloverSnare vascular retrieval snares.

The FDA issued a warning this month on Cook Medical's medical device recall, warning that a defect in certain of the company's CloverSnare 4-Loop Vascular Retrieval Snares could harm patients.

Federal device regulators gave the recall Class I status, reserved for "situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death."

Cook Medical, Food & Drug Administration (FDA)

News Well, Food & Drug Administration (FDA), Recalls, Vascular

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