Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

FDA device recall Z-2172-2026 · posted 2026-05-13 · Open, Classified

Recall details

Recalling firm

Edwards Lifesciences, LLC

Reason for recall

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

Action taken

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.

Root cause

Labeling design

Status

Open, Classified

Product code

NPW

Distribution

Worldwide - US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD

Date initiated

2026-03-27

Date posted

2026-05-13

Location

Irvine, CA