Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO — Class II medical device recall Z-2172-2026
Ongoing recall by Edwards Lifesciences, LLC, reported 2026-05-20, distributed nationwide. Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
| Recall number | Z-2172-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Irvine, CA, United States |
| Recall initiated | 2026-03-27 |
| Classified | 2026-05-13 |
| Reported by FDA | 2026-05-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, GB, SA |
| Reason classes | labeling |
| Model numbers | 9850TDS |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2172-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.