Medtronic recalls heart valve delivery system due to safety risk

July 7, 2026 - 02:47

Medtronic has announced a recall for a specific heart valve delivery system, citing a safety risk that could affect patients. The recall involves the company's Evolut FX and Evolut PRO+ delivery systems, which are used to implant aortic valves during transcatheter aortic valve replacement procedures. The issue stems from a potential failure in the device's balloon inflation mechanism, which could lead to complications such as difficulty in deploying the valve or, in rare cases, vessel damage.

This is not the first time this delivery system has faced scrutiny. The same device was previously recalled in 2022 due to similar concerns. Medtronic has since updated its instructions for use and is urging customers to inspect their inventory. Any unused delivery systems should be returned to the company to prevent potential harm.

The recall is classified as a Class I event by the U.S. Food and Drug Administration, the most serious category, indicating a reasonable chance that the device could cause serious injury or death. Medtronic has stated that no patient injuries have been directly linked to the current issue, but the company is taking proactive steps to address the risk. Healthcare providers are advised to follow the updated guidelines and to report any adverse events to the FDA. Patients who have already received the valve implant do not need to have it removed, but doctors should monitor them closely for any signs of complications.