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Recall Of Medtronic Guidewire High-Risk Class I, FDA Says

 
• By Shawn M. Schmitt

Medtronic’s Angiographic Guidewire Component, distributed since 2007, was recalled because the devices weren’t sterilized. It’s the company’s eighth class I recall this year.

The Medtronic logo is seen on an LED screen in the background while a silhouetted person uses a smartphone in the foreground.

The US Food and Drug Administration says a recall by Medtronic PLC of its Angiographic Guidewire Component devices is high-risk class I.

The company’s vascular division recalled nearly 55,000 of the guidewires on 4 May; they were distributed from November 2007 through...

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