CARDIOHELP Emergency Drive — Class I medical device recall Z-0420-2024
Ongoing recall by Maquet Medical Systems USA, reported 2023-12-13, distributed nationwide. Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead
| Recall number | Z-0420-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Medical Systems USA, Wayne, NJ, United States |
| Recall initiated | 2023-10-10 |
| Classified | 2023-12-07 |
| Reported by FDA | 2023-12-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BR, CA, CH, CL, CN, CZ, DE, ES, FI, FR, GB, HK, IE, IN, IT, JO, JP, MX, NZ, PK, PT, RU, SE, TH, TW, ZA |
| UPC / GTIN / UDI-DI | 04037691643526 |
| Serial numbers | 90421507, 90421980, 90423121, 90424277, 90425259, 90425366, 90425438, 90425443, 90425568, 90425570, 90425588, 90425716, 90425747, 90425748 |
| Model numbers | 701048002, 701076205 |
Product
CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.
Reason for recall
Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inappropriate low blood flow. Potential associated harms are ischemia and hypoxia.
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-0420-2024. 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.