Warning
Edwards Lifesciences Recalls Edwards EVOQUE tricuspid delivery system REF:9850TDS
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-2172-2026Medical Device
Edwards Lifesciences Recalls Edwards EVOQUE tricuspid delivery system REF:9850TDS
Edwards Lifesciences, LLC · Class II — Moderate Risk
Product Description
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Reason for Recall
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A Class II FDA recall has been issued for a medical device from Edwards Lifesciences, LLC, initiated on March 27, 2026. Labeling update to provide warning if functionality of the valve replacement delivery system is compromised. The product was distributed internationally, including the United States. While not the highest severity, consumers should exercise caution and stop using the product until the recall is resolved.
Sources: FDA openFDA Enforcement Database
This recall appears in: Medical Device Defects.