Edwards pulls some Sapien M3 heart valve delivery systems after death
Edwards Lifesciences has asked hospitals to pull four lots of the system used to place its Sapien M3 mitral heart valve. Balloons burst during inflation in three cases, and the company linked one death and one serious injury to the problem. The FDA issued an early alert.
Edwards Lifesciences has pulled four lots of the delivery system used to implant its Sapien M3 mitral heart valve after balloons burst during inflation in three cases, according to a Food and Drug Administration "early alert," TCTMD and Fierce Biotech reported.
The company sent customers a notice on Oct. 5 telling them to check their stock and remove Commander M delivery systems from the affected lots, Fierce Biotech reported. TCTMD listed the lot numbers as 67718561, 67804014, 67887043 and 67887044. The FDA alert was published Oct. 15.
As of Oct. 5, the company had "reported one death and one serious injury associated with this issue," according to the FDA notice, Fierce Biotech reported.
The FDA said a burst balloon can cause an embolism, a blockage in a blood vessel. It can also leave doctors unable to pull the device back through the guide sheath, which may require more procedures, including surgery. "Because this patient population is deemed unsuitable for surgery, these interventions carry a high risk of serious adverse health consequences including death," the agency said, TCTMD reported.
The FDA said it is reviewing information about "this potentially high-risk device issue" and will update the public as it learns more, TCTMD reported.
The system lets doctors replace a mitral valve through a blood vessel without open-chest surgery, Fierce Biotech reported. The FDA approved Sapien M3 in December 2025 for patients with leaking or poorly working mitral valves who are not good candidates for surgery or a less invasive repair, TCTMD reported. That approval was backed by a single-arm trial called ENCIRCLE.
It has been a tough year for Edwards, Fierce Biotech reported. In January, the company abandoned its planned $945 million purchase of heart valve developer JenaValve after a federal judge granted the Federal Trade Commission's request to block the deal.
TCTMD and Fierce Biotech rely mainly on the FDA notice, and neither included comment from Edwards on what caused the balloons to burst.
What we know: Four lots were pulled after three balloon bursts, linked to one death and one serious injury.
What we don't: What caused the bursts and whether other lots are affected.
Where outlets agree TCTMD and Fierce Biotech both report that Edwards pulled four lots of its Commander M delivery system after three balloon bursts tied to one death and one serious injury.
Where they differ The cited reports agree on the key facts so far.