FDA Device recall Z-0420-2024
CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205
- FDA Device
- Class I
- ongoing
- Published 2023-12-13
On 2023-12-13 the FDA classified a Class I recall of CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205 by Maquet Medical Systems Usa, citing 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. Potenti….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0420-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-10-10 |
| Published | 2023-12-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Maquet Medical Systems Usa |
| Distribution | US |
Product
CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.
Reason
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.
Identifiers
| code_info | Part No. 701048002: UDI - 04037691643526; Serial Numbers 90425259 to 90425748 (Excluding 90425438, 90425443, 90425568,…Part No. 701048002: UDI - 04037691643526; Serial Numbers 90425259 to 90425748 (Excluding 90425438, 90425443, 90425568, 90425570, 90425588, 90425716) [***Updated 1/8/24 to include Serial numbers 90421507, 90421980, 90424277. Serial numbers 90425366 and 90423121 are additionally included in the scope due to internal complaints, but these units were corrected prior to the field action initiation and therefore are not included in customer notification***] Part No. 701076205: No UDI; Serial Numbers 90425438, 90425443, 90425568, 90425570, 90425588, 90425716, 90425747, 90425748 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0420-2024%22
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