Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
Quick Facts at a Glance
- Recall Date
- March 27, 2026
- Hazard Level
- HIGH
- Brand
- Edwards Lifesciences
- Geographic Scope
- 1 states
Hazard Information
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Edwards Lifesciences, LLC or your healthcare provider for instructions. Notification method: E-Mail
Get instant alerts for Edwards Lifesciences recalls
Be the first to know. Free instant alerts to your inbox.
Full Description
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO. Reason: Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.. Classification: Class II. 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.
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
Get instant alerts for recalls that affect you. Free forever.