Edwards EVOQUE tricuspid delivery system recallZ-2172-2026 · Edwards Lifesciences, LLC · initiated Mar 27, 2026
Class II Open, Classified All recalls posted in May 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Edwards Lifesciences, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
FDA root cause category: Labeling design
What the company is doing
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.
Recall details
- Recall number
- Z-2172-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Mar 27, 2026
- Posted by the FDA
- May 13, 2026
- Recalling firm
- Edwards Lifesciences, LLC
- Product code
- NPW
- FDA submissions
- P230013
- 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.
Product description
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Code information (models, lots, serial numbers)
All Lots/UDI:0690103D004EVD000V5
Other devices under the same FDA submission
5 devices cleared under P230013 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- EVOQUE 9850TDSUSEdwards Lifesciences LLC · Prosthesis, Tricuspid Valve, Percutaneously Delivered14 deaths52 reports
- EVOQUE 9850EV48USEdwards Lifesciences LLC · Prosthesis, Tricuspid Valve, Percutaneously Delivered3 deaths42 reports
- EVOQUE 9850EV52USEdwards Lifesciences LLC · Prosthesis, Tricuspid Valve, Percutaneously Delivered2 deaths40 reports
- Edwards EVOQUE Valve 9850EV56USEdwards Lifesciences LLC · Percutaneously Delivered Prostheses And Tricuspid Valves1 death29 reports
- EVOQUE 9850EV44USEdwards Lifesciences LLC · Prosthesis, Tricuspid Valve, Percutaneously Delivered2 deaths22 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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