CARDIOHELP-i Heart Lung Support System- A blood oxygenation and… — Class II medical device recall Z-0555-2024
Ongoing recall by Maquet Medical Systems USA, reported 2023-12-20, distributed nationwide. Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits fo
| Recall number | Z-0555-2024 |
|---|---|
| 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 | 2023-11-06 |
| Classified | 2023-12-14 |
| Reported by FDA | 2023-12-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GH, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KR, KW, KY, LB, LT, LU, LV, MX, MY, NL, NO, NP, NZ, OM, PA, PH, PK, PL, PT, QA, RO, RS, RU, SA, SE, SG, SI, SK, TH, TR, TW, UA, VN, ZA |
| Quantity | 1,595 units |
| UPC / GTIN / UDI-DI | 04037691658384, 04058863074863 |
| Model numbers | 701072780 |
Product
CARDIOHELP-i Heart Lung Support System- A 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 Part Number: 701072780, (CARDIOHELP-I US); 701048012 (CARDIOHELP-I NON US)
Reason for recall
Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the venous bubble sensor (VBS) and the automatic lock in the Minimized Extracorporeal Circulation (MECC) ThApp
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-0555-2024. 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.