The FDA issued its own alert this week, saying three incidents as of earlier this month have resulted in one death and one serious injury — as a burst balloon can cause an embolism or become unable to be retrieved through the catheter’s sheath, requiring surgical interventions in patients potentially at a high risk for an open procedure.
The issue spans four lots of Edwards’ Commander M delivery systems, used with its Sapien M3 TMVR implant for mitral regurgitation. The company previously sent a letter notifying customers October 5, and urged them to return any impacted products to the manufacturer.
The FDA’s early alert labeled the issue as high-risk but did not make a formal recall classification, and the agency said it would work to update the public as new information becomes available.
The Sapien M3 was approved in December 2025 as the first minimally invasive mitral regurgitation therapy to employ a transseptal approach. Designed for patients deemed unsuitable for surgery or transcatheter edge-to-edge repair, the valve’s implantation includes a two-step process that starts with the delivery of a nitinol dock to anchor it in place.
