Recall Z-2172-2026 ยท NPW Percutaneously Delivered Prostheses And Tricuspid Valves
Edwards Lifesciences, LLC
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
| Date | May 13, 2026 (initiated Mar 27, 2026) |
| Status | Open, Classified |
| Reason | Labeling update to provide warning if functionality of the valve replacement delivery system is compromised. |
| Root cause | Labeling design |
| 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 xxxx@edwards.com. Electronic signatures may also be used, where available, to facilitate physician acknowledgment. |
| 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, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Saudi Arabia, Germany, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.