The Certitude Delivery System is used to deliver the Sapien 3, a transcatheter aortic heart valve replacement (THV) that is designed to treat aortic stenosis (abnormal narrowing of the aorta).
During implantation, the valve is crimped to the Certitude Delivery System’s balloon before the Sapien 3 is inserted into the body.
The recall was announced due to a manufacturing problem. There is a molding overflow defect in the button valve in the Certitude Delivery System’s loader, according to the Food and Drug Administration.
The problem is that the overflow material could potentially detach and travel in the patient’s bloodstream, resulting in a life-threatening embolism.
The recall involves approximately 1,730 devices from lots that were manufactured between November 22, 2016 and July 10, 2017.
The recall involves Lot numbers between 60677270 and 60990824.
The following model numbers were recalled: 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A, 9600SDS20A, 9600SDS23A, 9600SDS26A, 9600SDS29A
Edwards Lifesciences previously warned consumers about the issue in July 2017.
The company called the issue an “old recall” and said there were no incidents reported:
All potentially affected inventory was swapped out without disruption, and there were no patient safety issues and no customer complaints.”
For more information, customers may call Edwards Customer Service at 1-800-424-3278, from 6:00 AM to 4:30 PM (Pacific Time).