FDA Announces Recall Of Boston Scientific’s Lotus Edge TAVR System
The US agency announced on 11 January a recall of the Lotus Edge transcatheter aortic valve replacement (TAVR) system – a device that Boston Scientific stopped making and voluntarily recalled two months ago.
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The company is recalling all unused Lotus Edge inventory and will stop developing the Lotus platform while shifting resources to support its Acurate neo2 transcatheter aortic valve system. The decision will cost the company up to $300m.
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