Quick Facts at a Glance
- Recall Date
- March 27, 2026
- Hazard Level
- HIGH
- Brand
- Edwards Lifesciences
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Edwards Lifesciences
- Model numbers
- All Lots/UDI:0690103D004EVD000V5
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 27, 2026
Reported by FDA DEVICE
May 20, 2026
RecallRadar source check
May 27, 2026
Consumer action
Use the official remedy and keep documentation.
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
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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.
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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?
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