Documentary record · October 19, 2026 edition
Edwards SAPIEN M3 Commander M delivery systems: FDA Early Alert
SOURCE-VERIFIED · HUMAN REVIEW PENDING
Event date
October 15, 2026
Lifecycle state
EARLY ALERT (device issue communication)
Source published
October 15, 2026
Source checked
October 20, 2026
Published on KPSGILL
Edwards reported three balloon-burst events on specific lots (67718561, 67804014, 67887043, 67887044). These carry a risk of embolization or a non-retrievable device that may need surgery. As of October 5, Edwards had reported one death and one serious injury associated with the issue. Edwards told customers on October 5 to remove the affected lots.
Does not establish
a recall classification. The alert is addressed to facilities that stock the delivery system; it gives no instructions to patients who already have a valve.
Sources
- FDA Early Alert Edwards SAPIEN M3 delivery system Primary · 2026-10-15 · checked 2026-10-19
- FDA Early Alert (one death, one serious injury as of Oct 5) Primary · 2026-10-15 · checked 2026-10-20
Related on this site
Register: the record store · record id fda-early-alert-edwards-sapien-m3-commander-2026-10-15 · SOURCE-VERIFIED · HUMAN REVIEW PENDING.