CARDIOHELP-i System — Class II medical device recall Z-1831-2024
Ongoing recall by Maquet Medical Systems USA, reported 2024-05-22, distributed nationwide. The firm identified that the measured patient leakage current in some devices significantly exceeded expected
| Recall number | Z-1831-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Medical Systems USA, Wayne, NJ, United States |
| Recall initiated | 2024-04-15 |
| Classified | 2024-05-16 |
| Reported by FDA | 2024-05-22 |
| Distributed | Nationwide (US) |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 04037691658384 |
| Serial numbers | 90410021, 90410024, 90410025, 90410026, 90410028, 90410029, 90410030, 90410031, 90410034, 90410035, 90410036, 90410043, 90410044, 90410045, 90410046, 90410047, 90410048, 90410049, 90410050, 90410051, 90410052, 90410053, 90410054, 90410055, 90410056 and 123 more |
| Model numbers | 70104.8012, 70104.8012R |
Product
CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
Reason for recall
The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.
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-1831-2024. 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.