Z-2172-2026 Class II Ongoing
FDA device recall Z-2172-2026 was initiated by Edwards Lifesciences, LLC on March 27, 2026 and is designated Class II. Reason for recall: Labeling update to provide warning if functionality of the valve replacement delivery system is compromised. The recall status is 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