FDA early alert identifies four lots of Commander M heart-valve delivery systems
FDA says facilities should remove four affected lots of Edwards Commander M delivery systems following reports of balloons bursting during inflation.
What the record says
FDA's October 15 early alert identifies Commander M delivery systems used with SAPIEN M3 transcatheter mitral valve replacement. Affected lots are 67718561, 67804014, 67887043 and 67887044. The notice says Edwards reported three balloon-burst incidents and, as of October 5, one death and one serious injury associated with the issue.
Source details and supporting locations.
Practical next step
Healthcare facilities should check inventory against the exact lot numbers, follow the FDA notice and work with their Edwards representative to return affected products.
Limits and what is not established
The notice is an early alert while FDA reviews information. Other lot numbers are not covered by the stated action. Reported events associated with an issue do not by themselves establish causation; patients should discuss care questions with their clinical team.
Sources checked October 21, 2026. Later notices may change instructions or arrangements.
Original sources
U.S. Food and Drug Administration: original information