2 Dead In Class I Recall Of Medtronic Stents

 
• By Shawn M. Schmitt

The medtech giant yanked from shelves in July its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology. The recall was labeled high-risk class I by the US FDA on 20 September. It’s the company’s ninth class I this year.

Sign of Medtronic at Canada Headquarters in Brampton, Ontario, Canada.

Two deaths have been linked to a recall of Medtronic PLC stents that was labeled high-risk class I by the US Food and Drug Administration on 20 September, the agency says.

The manufacturer on 13 July yanked from shelves its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology. The stents were distributed from April 2019 to August...

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