Early Alert: Transcatheter Mitral Valve Delivery System Issue From Edwards Lifesciences

Recalling firm: Edwards Lifesciences
Product: Transcatheter Mitral Valve Delivery System
Reason: Potential balloon burst during inflation can lead to embolism or the need for surgery.
Category: medical device recall
Country: United States
Agency: FDA-MEDWATCH-RSS
Recall date: 2026-10-15
Status: Ongoing

Recall details on Nibble Recalls: https://trynibble.app/recalls/8d38b61a-55f9-41ac-90e8-f34a2cb46987