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# Boston Scientific Recalls Lotus Edge Aortic Valve
- URL: https://www.fdaweb.com/boston-scientific-recalls-lotus-edge-aortic-valve/
- Published: 2021-01-11T12:00:00.000Z
- Updated: 2026-09-14T16:42:01.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148418

Boston Scientific has recalled all unused inventory of its Lotus Edge Aortic Valve System due to “complexities” associated with the product delivery system, according to a [recall notice](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/boston-scientific-announces-lotus-edgetm-aortic-valve-system-voluntary-recall-and-product?utm%5Fmedium=email&utm%5Fsource=govdelivery). The recall is related specifically to the delivery system, and the valve “continues to achieve positive and clinically effective performance post-implant,” the notice says. There is no safety issue for patients who currently have the implanted device. The company says that because of the additional time and investment required to develop and reintroduce an enhanced delivery system, it has decided to retire the entire Lotus product platform immediately. All related commercial, clinical, research and development and manufacturing activities will also cease.