FDA Classifies Medtronic's Worldwide Voluntary Field Action on Guidewires as Class I Recall

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA Classifies Medtronic's Worldwide Voluntary Field Action on Guidewires as Class I Recall

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FDA Classifies Medtronic's Worldwide Voluntary Field Action on Guidewires as Class I Recall

11/15/2013 08:42 PM EST

Medtronic, Inc. (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) has classified the company's recently initiated voluntary field action related to certain guidewires as a Class I recall. Based on an internal investigation following a limited number of complaints, including one patient injury, Medtronic began notifying hospitals and distributors worldwide the week of Oct. 21 that some models of its guidewires from recent lots have the potential for the coating on their surface to delaminate and detach.

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