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.
The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.
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.
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.
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.
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.
Verify your Cardiohelp-i system's part number and serial number against the list provided in the recall notice.
The recall states that measured patient leakage current in some devices exceeds expected levels, but the exact risk isn't specified. Affected units should be checked as per the recall instructions.
Check your device's part number and serial number against the list provided in the recall notice. If affected, follow the action steps outlined in the recall.
Look 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.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1831-2024 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1831-2024 from Maquet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
