Medtronic Recalls CoreValve TAVR Component Due to Presence of Particulate Matter

Thursday, August 6, 2015

Source: FierceMedicalDevices

Medtronic ($MDT) is recalling 6,912 units of the loading system for its CoreValve Evolut R transaortic valve replacements following reports of the presence of particulates. The FDA just classified it as a Class 1 corrective action, reserved for situations in which "there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."

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