Edwards Lifesciences, LLC recalls Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.

On March 27, 2025, Edwards Lifesciences issued a Urgent: Medical Device Recall (Correction) Notification via mail. Edwards ask consignees to take the following actions: 1. There is no need to return any product and no patient follow-up or notification is necessary. 2. Please review this Urgent: Medical Device Recall (Correction) Notice . 3. Return the completed Customer Acknowledgment Form to your Edwards TMTT Representative or via email to xxxx@edwards.com. Electronic signatures may also be used, where available, to facilitate physician acknowledgment.

• FDA enforcement recordOfficial FDA database entry for Z-2172-2026
• FDA device classification · NPWOfficial FDA classification for this device type
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Edwards Lifesciences, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.