Maquet recalls Cardiohelp-i heart lung support systems with incorrect factory settings that could risk improper blood oxygenation. Affected units have specific part numbers and serial numbers up to 90415177.
Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the venous bubble sensor (VBS) and the automatic lock in the Minimized Extracorporeal Circulation (MECC) ThApp
Maquet is recalling Cardiohelp-i heart lung support systems due to incorrect factory settings that might lead to improper blood oxygenation and carbon dioxide removal. This could affect patients during critical medical procedures.
The device's factory settings were incorrectly described in the instructions, which could lead to improper blood oxygenation and carbon dioxide removal. This might cause complications during critical medical procedures.
Medical professionals using the Cardiohelp-i system for cardiopulmonary bypass procedures are most at risk. Patients receiving this support during surgery may be affected if the device malfunctions.
Check for part numbers 701072780 (US) or 701048012 (non-US) and serial numbers up to 90415177. The device is used for blood oxygenation and carbon dioxide removal during heart surgery.
Identify the part number and serial number to confirm if your Cardiohelp-i system is affected.
Part numbers 701072780 (US) and 701048012 (non-US) with serial numbers up to 90415177.
The recall record states no remedy is provided.
Incorrect factory settings in the device's instructions could lead to improper blood oxygenation and carbon dioxide removal during medical procedures.
We’ve drafted a message you can send Maquet Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0555-2024 — Maquet Medical Systems Maquet Medical Systems Hello, I own a Maquet Medical Systems that is covered by recall Z-0555-2024 from Maquet Medical Systems. 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.
