FDA MedWatch - LOTUS Edge Aortic Valve System by Boston Scientific: Recall and Product Discontinuation

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: LOTUS Edge Aortic Valve System by Boston Scientific: Recall and Product Discontinuation AUDIENCE: Patient, Health Professional, Risk Manager, Cardiology ISSUE: Boston Scientific Corporation is recalling of all unused inventory of the LOTUS Edge Aortic Valve System due to complexities associated with the product delivery system. The recall is related solely to the delivery system, as the valve continues to achieve positive and clinically effective performance post-implant. There is no safety issue for patients who currently have an implanted LOTUS Edge valve. For more information about this recall click on red button "Read Recall" below. BACKGROUND: The LOTUS Edge Valve System is a transcatheter aortic valve replacement system that consists of an artificial aortic heart valve and a delivery system used to implant the valve without the need for open-heart surgery. RECOMMENDATION: Patients who have a LOTUS Edge valve implanted should continue with their routine follow-up care. There is no need additional need for action. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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