FDA Device recall Z-0290-2024
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
- FDA Device
- Class II
- ongoing
- Published 2023-11-15
On 2023-11-15 the FDA classified a Class II recall of Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder) by Maquet Medical Systems Usa, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0290-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-12 |
| Published | 2023-11-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Maquet Medical Systems Usa |
| Distribution | US |
Product
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
Reason
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.
Identifiers
| code_info | UDI-DI: 04058863074863; Serial Numbers: 90414355 through 90414868 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Maquet Medical Systems Usa
- CARDIOHELP-i System
FDA Device · Class II · 2024-05-22 · Maquet Medical Systems Usa - Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077
FDA Device · Class II · 2024-02-21 · Maquet Medical Systems Usa - BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078
FDA Device · Class II · 2024-02-21 · Maquet Medical Systems Usa - Bubble Sensor (REF: 70105.5720)
FDA Device · Class II · 2024-02-14 · Maquet Medical Systems Usa - BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553
FDA Device · Class II · 2024-02-14 · Maquet Medical Systems Usa
All Maquet Medical Systems Usa recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0290-2024%22
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