Edwards LifeSciences has announced a recall of its Certitude Delivery System, which is used to deliver the company’s SAPIEN 3 transcatheter heart valve. The issue is a molding overflow defect in the button valve within the loader; there is a risk that the overflow material could detach when the delivery system is placed and embolize into the patient. The issue affects lot numbers between 60677270 and 60990824, with manufacturing dates from November 22, 2016–July 10, 2017 and distribution dates from January 9, 2017–July 17, 2017.
According to an alert on FDA’s MedWatch, Edwards sent affected customers a recall notification letter on July 21, 2017, detailing the risk of the device. Customers were told to return affected models to Edwards.