“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,” said Medtronic in the statement.
The company has recalled nearly 15,000 guidewires. A company spokesman told Reuters the recall is not expected to have a material impact on its financial results, news that could buffer IHI from any knee-jerk reactions to the recall headlines.
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