Maquet Cardiohelp-i System Recall: Excessive Patient Leakage Current Risk
Maquet recalls Cardiohelp-i blood oxygenation systems with potential patient leakage current exceeding safe levels. Affected units have specific serial numbers and part numbers listed in the recall notice.
Use caution until it’s fixed
The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.
Contact the company
What happened, in plain English
Maquet is recalling its Cardiohelp-i blood oxygenation and carbon dioxide removal system due to measured patient leakage current exceeding expected levels in some devices. This could pose a risk to patient safety during medical use. Read more at govinfonow.com/recall/55393-maquet-cardiohelp-i-system-recall-excessive-patient-leakage-current-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/55393-maquet-cardiohelp-i-system-recall-excessive-patient-leakage-current-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1831-2024
Cite this page
“Maquet Cardiohelp-i System Recall: Excessive Patient Leakage Current Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55393-maquet-cardiohelp-i-system-recall-excessive-patient-leakage-current-risk. Based on FDA recall #Z-1831-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1831-2024%22&limit=1).
Why it’s dangerous
The device measures patient leakage current, which in some units significantly exceeds safe levels. This could potentially cause electrical issues during medical procedures, though the exact risk mechanism isn't specified in the recall.
Who’s affected
Medical facilities using the Cardiohelp-i system with the listed serial numbers or part numbers are most at risk. Patients receiving treatment with these devices may be affected.
How to tell if you have this one
Check for part numbers 70104.8012 or 70104.8012R and serial numbers listed in the recall notice. The UDI-DI code 04037691658384 also identifies affected units.
- Brand
Maquet- Category
Medical device
What to do — step by step
Check Device Details
Verify your Cardiohelp-i system's part number and serial number against the list provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
FDA distribution: “US Nationwide distribution in the states of NJ & TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: New Jersey, Texas.
Recall timeline
FDA published this recall 37 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1831-2024 (April 15, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1831-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.