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# Early Alert: Transcatheter Mitral Valve Delivery System
- URL: https://www.fdaweb.com/early-alert-transcatheter-mitral-valve-delivery-system/
- Published: 2026-10-16T15:44:33.000Z
- Updated: 2026-10-16T15:44:33.000Z
- Author: David McFarland
- Tags: Devices

CDRH has issued an early alert after learning that Edwards Lifesciences notifed customers recommending certain delivery systems used for SAPIEN M3 transcatheter mitral valve replacement be removed from where they are used or sold. Affected devices:

  - Commander M delivery systems (for SAPIEN M3 Transcatheter Mitral Valve Replacement System); Lots: 67718561, 67804014, 67887043, and 67887044

Edwards says it has received three reports of balloons bursting during inflation. Potential injuries associated with the device failure include embolism and inability to retrieve the device through the guide sheath, which may require additional intervention, including surgery, an [agency notice](https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-transcatheter-mitral-valve-delivery-system-issue-edwards-lifesciences?utm%5Fmedium=email&utm%5Fsource=govdelivery) says.

The device is used to deliver a replacement mitral heart valve to a patient’s heart through their blood vessels, without requiring open chest surgery.