Medtronic Guidewires: Recall
MedSun: Newsletter #90, December 2013
FDA MedWatch Safety Alert
Medtronic, Inc. announced that FDA has classified the company's recently initiated voluntary field action related to certain guidewires. Based on an internal investigation following a limited number of complaints, 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. Additional information about the recall, including the lot numbers of affected product, is accessible through the Medtronic website.
Medtronic Guidewires: Recall. FDA MedWatch Safety Alert. November 19, 2013.