CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon… — Class III medical device recall Z-0595-2024
Ongoing recall by Maquet Medical Systems USA, reported 2023-12-27, distributed nationwide. CARDIOHELP-i System was not properly tested to measure leakage current
| Recall number | Z-0595-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Medical Systems USA, Wayne, NJ, United States |
| Recall initiated | 2023-11-14 |
| Classified | 2023-12-20 |
| Reported by FDA | 2023-12-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DO, EC, EG, ES, FI, FR, GB, GH, GR, HK, HR, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KR, KW, KY, LB, LU, MX, NL, NO, NZ, OM, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SK, TH, TR, TW, UA, VN, ZA |
| Quantity | 1,594 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 04037691658384, 04058863074863 |
| Model numbers | 701072780 |
Product
CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product REF Numbers: 701072780; 701048012
Reason for recall
CARDIOHELP-i System was not properly tested to measure leakage current
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-0595-2024. 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.