Edwards EVOQUE tricuspid delivery system recall: Labeling Error
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Why was Edwards EVOQUE tricuspid delivery system recalled?
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Lots/UDI:0690103D004EVD000V5
- Product
- Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
- Recalling firm
- Edwards Lifesciences, LLC
- 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.
- Recall date
- May 20, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)