FDA confirms new Class I recall for heart valve delivery system due to safety risk
The U.S. Food and Drug Administration (FDA) has confirmed that a safety issue with certain accessories used to implant the Sapien M3 transcatheter mitral valve replacement (TMVR) system has been ruled a Class I recall.
This is the agency’s most severe recall classification. It means using the devices in question could cause “serious adverse health consequences or death.”
This Class I recall only covers four specific lots of these devices: 67718561, 67804014, 67887043 and 67887044. Delivery systems distributed as part of those four lots should not be used to treat any patients going forward. However, all other delivery systems sold with the Sapien M3 TMVR system can be used as normal.
The FDA first released information about this recall in October while the issue was still under investigation. As the agency explained at the time, four lots of the Commander M delivery systems sold with the Sapien M3 TMVR systems were being recalled due to an increased risk of the balloons bursting during inflation. Four serious injuries and one death were linked to the issue.
Key details about the Sapien M3 TMVR system
The Sapien M3 TMVR system first secured FDA approval in January for the treatment of mitral regurgitation (MR). It was designed for patients with symptomatic moderate-to-severe or severe MR who may not be good candidates for mitral valve surgery or transcatheter edge-to-edge repair. The device is also indicated to treat high-risk patients who present with symptomatic mitral valve dysfunction linked to mitral annular calcification.
At TCT 2026 in San Diego, late-breaking data confirmed that the Sapien M3 TMVR system is associated with positive two-year outcomes for patients requiring TMVR. The device was confirmed to be both safe and effective in patients two years after treatment. Those findings were simultaneously published in JACC.[1]
Again, this recall only includes certain Commander M delivery systems. No issues have been identified with the actual Sapien M3 TMVR devices.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.