Maquet recalls Cardiohelp-i heart lung support systems due to untested leakage current. This device pumps blood during surgery; affected units have specific serial numbers up to 90415172.
CARDIOHELP-i System was not properly tested to measure leakage current
Maquet is recalling its Cardiohelp-i heart lung support system because it wasn't properly tested for leakage current. This could pose a risk during medical procedures where the device pumps blood.
The system wasn't properly tested to measure leakage current, which could lead to electrical issues during medical procedures. This might cause harm to patients or medical staff if the device malfunctions while supporting blood circulation.
Medical professionals using the Cardiohelp-i system during surgery are most at risk. Patients receiving this life-support device during cardiac or pulmonary procedures may be affected.
Check the serial number on the device, which should be up to and including 90415172. The product includes specific reference numbers: 701072780, 701048012, and UDI-DI codes 04058863074863 and 04037691658384.
Look for the serial number on the device, which should be up to and including 90415172.
The Cardiohelp-i system wasn't properly tested to measure leakage current, which could lead to electrical issues during medical procedures.
The product has serial numbers up to and including 90415172.
The recall record does not specify a remedy.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-0595-2024 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-0595-2024 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.
