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FDA Classifies Medtronic Inc's Worldwide Voluntary Field Action On Guidewires As Class I Recall

Friday, 15 Nov 2013 07:00pm EST 

Medtronic Inc announced 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. The notification requested that all potentially affected units be quarantined immediately and returned to the Company as soon as possible for credit and replacement. Medtronic has also taken the necessary steps to prevent future shipments of the recalled products and notified regulatory agencies around the world as appropriate. The FDA defines a Class I recall as a situation in which there is a reasonable probability that use of, or exposure to, a violative product will cause serious adverse health consequences or death. 

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