The FDA announced it has classified Edwards Lifesciences’ past voluntary recall of a transcatheter heart valve delivery system as a Class I recall, the most serious kind.
In an email to Cardiology Today’s Intervention, the company said the move concerned “an old recall that was resolved” without any harm to patients.
The delivery system (Certitude) is used to deliver a balloon-expandable transcatheter heart valve (Sapien 3, Edwards Lifesciences) in transcatheter aortic valve replacement procedures, according to an alert from the FDA.
The delivery system is for transapical procedures, which make up a small percentage of all TAVR procedures, the company told Cardiology Today’s Intervention.
The recall applies to model/item numbers 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A, 9600SDS20A, 9600SDS23A, 9600SDS26A and 9600SDS29A, manufactured from November 22, 2016 to July 10, 2017 and distributed January 9, 2017 to July 17, 2017.
According to the FDA alert, a molding overflow defect in the button valve within the loader could potentially detach during placement of the delivery system, causing embolism. This could cause an obstruction to blood flow to critical organs, resulting severe neurologic, cardiac, limb, renal or gastrointestinal injury, the agency stated.
The problem “was caught during testing and all potentially affected inventory was swapped out without disruption,” the company stated in the email. “There were no patient safety issues and no customer complaints.”
Edwards Lifesciences has sent a recall notification letter to customers directing them to complete the acknowledgement form, check all inventory for affected models of the device and to return the form and all affected models of the device to the company, according to the FDA announcement.
The announcement urges healthcare professionals and patients to report adverse events or side effects related to the use of the delivery system to the FDA’s Medwatch Safety Information and Adverse Event Reporting Program.
Editor’s Note: This article was updated on Jan. 15, 2018 to add information from Edwards Lifesciences about the recall.