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 device giant recalled its Ingenio family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) because there’s a chance they can slip into safety mode, posing a risk to patients. It’s Boston Scientific’s fifth high-risk class I this year.
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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