FDA Device recall Z-2172-2026
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
- FDA Device
- Class II
- ongoing
- Published 2026-05-20
On 2026-05-20 the FDA classified a Class II recall of Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO by Edwards Lifesciences, citing labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2172-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-27 |
| Published | 2026-05-20 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Edwards Lifesciences |
| Distribution | US |
Product
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Reason
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
Identifiers
| code_info | All Lots/UDI:0690103D004EVD000V5 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2172-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.