Cardiohelp-i — Class II medical device recall Z-0290-2024
Ongoing recall by Maquet Medical Systems USA, reported 2023-11-15, distributed nationwide. It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was ins
| Recall number | Z-0290-2024 |
|---|---|
| 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 | 2023-10-12 |
| Classified | 2023-11-09 |
| Reported by FDA | 2023-11-15 |
| Distributed | Nationwide (US) |
| Quantity | 1,022 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04058863074863 |
| Serial numbers | 90414355 |
| Model numbers | 701072780 |
Product
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
Reason for recall
It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual force.
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-0290-2024. 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.