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Open, Classified

Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

FDA Recall Z-2172-2026 · Posted 2026-05-13

Recalling FirmEdwards Lifesciences, LLC
Recall StatusOpen, Classified
Product CodeNPW
Date Initiated2026-03-27

Reason for Recall

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

Firm Action

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 [email protected]. Electronic signatures may also be used, where available, to facilitate physician acknowledgment.

Root Cause

Labeling design

Distribution Pattern

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, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Saudi Arabia, Germany, United Kingdom.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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