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Edwards Lifesciences, LLC: Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

Medical DevicesSource: FDA (device) · Date: 2026-05-20

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Edwards Lifesciences, LLC
Product
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Reason / hazard
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
Classification
Class II
Status
Ongoing
Distribution / sold at
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 initiated
2026-03-27
Code info
All Lots/UDI:0690103D004EVD000V5
Voluntary mandated
Voluntary: Firm initiated
City
Irvine
State
CA
Country
United States
Event id
98633
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