FDA DevicesClass II
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Published: May 20, 2026Recall ID: Z-2172-2026Category: devicesCountry: US
Reason for Recall / Hazard
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
Product Description & Identification
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Affected Products
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Additional Source Details
| Field | Value |
|---|---|
| City | Irvine |
| State | CA |
| Event id | 98633 |
| Address 1 | 1 Edwards Way |
| Code info | All Lots/UDI:0690103D004EVD000V5 |
| Postal code | 92614-5688 |
| Report date | 20260520 |
| Product type | Devices |
| Reason for recall | Labeling update to provide warning if functionality of the valve replacement delivery system is compromised. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260327 |
| Initial firm notification | |
| Center classification date | 20260513 |
Overview
- Recalling FirmEdwards Lifesciences, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - 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.