Z-2172-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2026
- Initiation Date
- March 27, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
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.
Distribution Pattern
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.
Code Information
All Lots/UDI:0690103D004EVD000V5