The US Food and Drug Administration (FDA) has conveyed a ‘potentially high-risk’ issue affecting certain mitral valve delivery systems marketed by Edwards Lifesciences, which have been linked to a patient death.

The FDA alert concerns certain delivery systems used to implant Edwards’ SAPIEN M3 mitral valve during transcatheter mitral valve replacement (TMVR) procedures.

Edwards’ Commander M delivery system is a key part of the company’s Sapien M3 TMVR system. Ahead of insertion into a patient, Sapien M3 is mechanically collapsed directly onto the deflated balloon section of the Commander M catheter, allowing for the mitral valve to be delivered to a patient’s heart through their blood vessels.

The life sciences giant issued a letter to affected customers after receiving three reports of balloons bursting during inflation. Potential injuries associated with balloon burst include embolism and inability to retrieve the device through the guide sheath – a situation that may require additional intervention, including surgery, Edwards stated.

Given that the recipient patient population for this procedure is typically deemed unsuitable for surgery, such interventions carry a high risk of serious adverse health consequences, including death, Edwards added.

Edwards has reported one death and one serious injury associated with this issue, as of 5 October.

The FDA alert advises that the affected product lots be removed from use with immediate effect. Medical Device Network has reached out to Edwards regarding the alert.

Edwards Sapien M3 system received FDA approval in December 2025 and is the first transcatheter therapy that uses a transseptal approach for treating mitral regurgitation (MR) to receive approval from the agency.

Specifically, the system is indicated for the treatment of symptomatic moderate-to-severe or severe MR in patients who have been deemed unsuitable for surgery or transcatheter edge-to-edge repair (TEER) therapy. It is also indicated for the treatment of symptomatic mitral valve dysfunction, severe mitral stenosis (MS), or moderate MR associated with mitral annular calcification (MAC) in patients who are deemed unsuitable for surgery or TEER therapy.

This is not the first time that a delivery system for Edwards's Sapien range has been involved in an FDA alert. Edwards’ Sapien 3 ultra delivery system was tagged as a Class I recall in July 2019. Also related to a ‘balloon-burst’ issue, the recall encompassed 2,579 units.