- Recalling firm
- Edwards Lifesciences, LLC
- Reason for recall
- Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
- Affected products (lot / model / serial)
- All Lots/UDI:0690103D004EVD000V5
- 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.
- Firm location
- Irvine, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2172-2026
- Recall initiated
- March 27, 2026
- FDA classification date
- May 13, 2026
- FDA report date
- May 20, 2026
- FDA event ID
- 98633
- Last updated on HTM Vibe
- July 24, 2026