CLASS II ONGOING Device recall · Reported 15 Nov 2023 · FDA Enforcement Report
Cardiohelp-i, blood oxygenation recalled by Maquet Medical Systems U
Maquet Medical Systems USA is recalling Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780, distributed nationwide in the US. The recall was initiated on 12 Oct 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0290-2024
- FDA event ID
- 93013
- Recalling firm
- Maquet Medical Systems USA, Wayne, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Oct 2023
- FDA classified
- 9 Nov 2023
- Reported
- 15 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 12 Oct 2023 | Recall initiated by company | |
| 9 Nov 2023 | Classified by FDA | +28 days |
| 15 Nov 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI-DI: 04058863074863; Serial Numbers: 90414355 through 90414868
Where was it sold?
US Nationwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Maquet Medical Systems USA
All 41| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Cardiohelp-i System recalled by Maquet Medical Systems U | Maquet Medical Systems USA | Packaging Defects | Nationwide |
| Device | CLASS II | Model No. Beq-hls 5050 USA, HLS Set Advanced 5.0, Product Code/Part recalled | Maquet Medical Systems USA | Sterility | Nationwide |
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