Edwards recalls Sapien mitral delivery systems after balloon failures and one death

Edwards is asking customers to return four lots of Commander M delivery systems used with its Sapien M3 devices after reports of balloons bursting during procedures. MedTech Dive reported that the recall was tied to one death. The FDA said units with other lot numbers are not affected and can continue to be used.

The company told MedTech Dive that the four lots represent fewer than 200 delivery systems and that it is working with customers on returns and replacements. Edwards received three reports of balloons bursting when inflated during a procedure. Leerink Partners analysts said the issue appeared batch-specific, rather than a broader platform issue, and predicted little financial impact to Edwards.