Edwards EVOQUE Tricuspid Delivery System Labeling Update for Valve Functionality
Edwards Lifesciences is updating labeling for the Edwards EVOQUE tricuspid delivery system (REF 9850TDS) to provide a warning if valve replacement delivery system functionality becomes compromised.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a labeling-only update (FDA Class II) with no reported injuries or illnesses. The update provides a warning about a potential functionality issue but does not indicate that the device has caused reported harm or failure. This is a precautionary labeling correction, consistent with a Moderate severity rating.
Plain-English summary
Edwards Lifesciences, LLC is issuing a labeling update for the Edwards EVOQUE tricuspid delivery system (REF 9850TDS, Sterile EO, all lots/UDI 0690103D004EVD000V5). The update provides warning information if the functionality of the valve replacement delivery system becomes compromised.
The affected product has been distributed worldwide, including nationwide distribution across the United States (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 internationally in Saudi Arabia, Germany, and the United Kingdom.
Healthcare providers who use or stock this device should review the updated labeling for the warning information regarding potential functionality compromise.
The recalled product
- Product
- Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
- Manufacturer
- Edwards Lifesciences, LLC
- Hazard
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots/UDI:0690103D004EVD000V5
Distribution
Distributed nationwide across the United States.