Maquet recalls Cardiohelp-i blood oxygenation systems with part numbers 701072780 and 701068550 due to risk of nut bolt breaking off during use, potentially causing injury.
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.
Maquet is recalling Cardiohelp-i blood oxygenation systems that could have a nut bolt breaking off with slight force, which might cause injury. This recall affects specific model numbers and serial ranges.
The nut bolt connecting the slide rail plate can break off with minimal manual force due to a weak weld. This breakage could lead to injury if the broken bolt causes damage to the device or patient.
Healthcare professionals using the Cardiohelp-i system for blood oxygenation are most at risk. Patients receiving treatment with this device may also be affected.
Check for part numbers 701072780 (Cardiohelp-i) or 701068550 (Slide Rail Holder) on the device. The serial numbers range from 90414355 to 90414868.
Verify the part numbers and serial numbers on your Cardiohelp-i system to confirm if it is affected.
The device may have a risk of nut bolt breakage with slight force, so it is not safe to use without checking for recall status.
Check the part numbers and serial numbers to see if it is in the recall range; if affected, contact Maquet for further instructions.
Look for part numbers 701072780 or 701068550 and serial numbers between 90414355 and 90414868.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-0290-2024 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-0290-2024 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.
