EV1000 Clinical Platform — Class I medical device recall Z-1193-2019
Terminated recall by Edwards Lifesciences, LLC, reported 2019-05-29, distributed nationwide. Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power
| Recall number | Z-1193-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Irvine, CA, United States |
| Recall initiated | 2019-03-21 |
| Classified | 2019-05-21 |
| Reported by FDA | 2019-05-29 |
| Terminated | 2023-11-28 |
| Distributed | Nationwide (US) |
| Quantity | 22,443 |
| Reason classes | device malfunction |
| Lot numbers | EV1000 |
| Model numbers | EV1000A, EV1000CS, EV1000NI |
Product
EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid management through the use of minimally invasive monitoring with the FloTrac sensor (or the Volume View sensor).
Reason for recall
Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets.
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-1193-2019. 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.